Safety Info – Page 12 – Drug Regulatory Authority of Pakistan

Recall Alert: Drug Product; INCIP 200mg Infusion (Batch # CPV-85) by Inventor Pharma Pvt Ltd, Karachi

Asad Ullah Recall Alerts January 23, 2024February 14, 2024

Recall Alert

DRAP Alert No	N^oI/S/01-24-03
Action Date	16^th January, 2024
Target Audience	· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc. · General Public
Problem / Issue	Federal Government Analyst, CDL Karachi has declared the Batch No. CPV-085 of product “INCIP Infusion” as of Substandard quality.

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch No	Manufacturer
INCIP 200mg Infusion Reg.No 088363	Ciprofloxacin	Batch No. CPV-85 Mfg. Date: 09-23 Exp. Date: 09-25	M/s Inventor Pharma (Pvt) Ltd, Karachi

Risk Statement:	The impact of the use of substandard infusion on the basis of visible particulate matter may introduce contaminants into the bloodstream that lead to adverse reactions or sepsis.
Action Initiated	-The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase surveillance in the market to ensure the effective recall of defective products(s). -Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk. -Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

Rapid Alert: Contaminated Propylene Glycol (Batch #C815N3OR41) Allegedly Produced by Dow Chemical Thailand

Asad Ullah Recall Alerts January 11, 2024April 9, 2024

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Rapid Alert

DRAP Alert No	N^oI/S/01-24-02
Action Date	11^th January, 2024
Target Audience	1. Regulatory Field Force. 2. Therapeutic Goods industry 3. Manufactures of Oral liquid preparations 4. Healthcare professionals
Problem Statement	The regulatory field force has identified a batch of Propylene Glycol (PG) that was used as a solvent in the manufacturing of oral liquid preparations. The batch was labelled as manufactured by Dow Chemical, Thailand. However, on analysis of a sample by the Central Drug Laboratory in Karachi, an unacceptable level of Ethylene Glycol was found..

The product identification details are as under: –

Therapeutic Good Affected:-

Product	Batch No*	Mfg Date	Exp. Date	Manufacturer (as per label)	Remarks
Propylene Glycol (Raw Material)	C815N3OR41	03-23	03-25	Dow Chemicals, Thailand	The sample is declared substandard for unacceptable levels of Ethylene Glycol (EG).

*Correction statement/corrigendum:
Verification of record/pictures shows that the identified batch number of contaminated propylene glycol was inadvertently written as C815N30R41 instead of C815N3OR41. Hence this batch number may be read as C815N3OR41.
Sincere apologies for the inconvenience this unanticipated ambiguity might have caused.

Dow Chemicals Thailand provided clarification to DRAP, stating that the identified samples were not their original product. Furthermore, the investigation revealed that their labels were false and that the samples were not manufactured by Dow Chemicals.

Risk Statement	Ethylene Glycol (EG) contaminated Propylene Glycol (PG) when used in oral liquid preparations, can lead to serious health risks due to EG’s toxicity. When ingested, EG is metabolized into toxic metabolites that can affect the central nervous system, and heart, and can cause kidney damage, which can be fatal.
Action Initiated	The Regulatory Field Force has taken possession of a contaminated batch of Propylene Glycol and is investigating the entire supply chain of this batch. The therapeutic goods manufacturer has been instructed to recall any finished products that were manufactured using the same lot of propylene glycol. The Regulatory Field Force has also been instructed to seize all oral preparations that were made using the same batch of propylene glycol if found in the market. DRAP has directed the therapeutic industry to hold finished products manufactured from any other lot of propylene glycol of Dow Chemical Thailand and ensure testing of finished products for EG/DEG contamination before releasing them into the supply chain.
Advice for Therapeutic Goods Manufacturers	Manufacturers of therapeutic goods are required to follow these instructions: _Recall Products: If any batch was manufactured using the same lot (C815N3OR41) of propylene glycol that has been identified as contaminated, all finished products from local and export markets should be recalled. –Hold Other Batches: All finished products manufactured from any other lot of propylene glycol of Dow Chemical Thailand should be held. These products should be tested for EG/DEG contamination before releasing them into the supply chain. –Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG. – Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination. –Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products. –Follow Guidelines: Adhere to the pharmacopoeia monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products. Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres. -Adverse Drug Reactions (ADR) or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	Consumers should stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately and report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

Recall Alert: Drug Product; IS-NS (0.9%) Infusion (Batch # B6-24) by ISIS Pharmaceutical & Chemical Works, Karachi

Asad Ullah Recall Alerts January 3, 2024January 8, 2024

Recall Alert

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DRAP Alert No	N^oI/S/12-23-48
Action Date	2^nd January, 2024
Target Audience	· Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Pharmacists, and Nurses. · Procurement Officers at Hospitals and Healthcare Institutions. · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
Problem / Issue	Federal Government Analyst, CDL Karachi has declared Batch No. B6-24 of product “IS-NS 0.9% INFUSION” as of Substandard quality.

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch No	Manufacturer
IS-NS 0.9% Infusion Reg.No 104066	0.9% Sodium Chloride	Batch No. B6-24 Mfg. Date: 08-23 Exp. date: 08-25	M/s. ISIS Pharmaceutical & Chemical Works, Karachi

Risk Statement:	The use of substandard products based on assay tests may alter the dose and hamper the efficacy of the product leading to sub-therapeutic effects.
Action Initiated	-The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase surveillance in the market to ensure the effective recall of defective products(s). -Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk. -Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

Rapid Alert; Drug Product: Crackdown on Illegal Manufacturing and Seizure of Falsified Drugs

Asad Ullah Recall Alerts December 29, 2023January 1, 2024

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Rapid Alert

DRAP Alert No	N^oI/S/12-23-46
Action Date	29th December, 2023
Target Audience	1. Regulatory Field Force. 2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores 3. Healthcare Professionals – Physicians, Pharmacists, and Nurses, Procurement officer at hospitals and institutions 4. General Public.
Problem Statement	On December 12, 2023, the regulatory field force in Karachi raided and shut down an illegal drug manufacturing facility. They collected product samples and sent them to the Central Drugs Laboratory (CDL) in Karachi for testing. The Federal Government Analyst at the CDL confirmed that the products seized by FID-III Karachi from the illicit site were “spurious”. The test results showed that these products lacked the stated active ingredients. There is a possibility that the fake manufacturers have infiltrated the supply chain with some of their falsified products.
Threats to Public Health	The use of falsified products will result in ineffective treatment. This may cause therapy failure which may lead to increased morbidity and also, mortality, in case of untreated infections. Moreover, the safety of these falsified products is also unknown.

The product identification details are as under: –

Therapeutic Goods Affected*:-

Product Name	Composition (as per label)	Batch / Lot	Mfg Date	Exp Date	Manufacture Name (as stated on label)	Illustrative Images
AL Coxime 400mg Capsule	Cefixime	110	04-23	03-25	M/s. Alpine Laboratories (Pvt) Ltd., Karachi	See DRAP Alert
Sinoxime 100mg/5ml Dry Suspension	Cefixime	101S13	10-23	09-25	M/s. Alcons Laboratories Pvt Ltd., Karachi
Flox-G 500mg Tablet	Levofloxacin	760	01-23	12-25	M/s. Alcons Laboratories Pvt Ltd., Karachi
Flox-G 250mg Tablet	Levofloxacin	761	01-23	12-25	M/s. Alcons Laboratories Pvt Ltd., Karachi
Amcox 125mg/5ml Suspension	Amoxicillin	23217	04-23	03-25	M/s. Alcons Laboratories Pvt Ltd., Karachi
Snagxone 1g injection	Ceftriaxone	L23-4	06-23	06-25	M/s Leckman Laboratories Pvt Ltd., Karachi
Leckzolid 600mg Tablets	Linezolid	002	—	09-24	M/s Leckman Laboratories Karachi
Uniclav 156.25mg/5ml Suspension	Co-amoxiclav	126	09-23	08-25	M/s. Uni-Tiech Pharmaceutical Pvt Ltd., Karachi

*The packaging of these products displays fake Drug Manufacturing Licenses (DML) and Drug Registration Numbers (DRN). None of these products are registered and no manufacturers with these names and addresses are licensed by DRAP.

Action Initiated	The Regulatory Field Force has been directed to increase the surveillance activities at Health facilities (Hospitals) in addition to markets and confiscate/seize these falsified products without any delay. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and halt the distribution/supply of these falsified products. Information related to the supplier of these falsified products should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of these falsified products.
Advice for Healthcare Professionals	-DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these falsified products. -Adverse Drug Reactions (ADR) or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	Consumers should not use these falsified products and should contact their physician or healthcare provider if they have experienced any problem related to taking or using any of these falsified products, and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

Recall Alert: Drug Product; Ketovet 100mg Injection (Veterinary use) (Batch # 2324108) by Vetz Pharmaceutical Pvt. Ltd, kotri

Asad Ullah Recall Alerts December 21, 2023December 21, 2023

Recall Alert

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DRAP Alert No	N^oI/S/11-23-45
Action Date	21st Dec, 2023
Target Audience	• Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores • Veterinarians • General Public
Problem / Issue	Federal Government Analyst, CDL Karachi has informed DRAP regarding the sample of product namely “Ketovet injection” Batch No. 2324108 manufactured by M/s. Vetz Pharmaceuticals (Pvt.) Ltd., Plot #Q1, S.I.T.E Area, Kotri, Hyderabad has been declared as of “Substandard” quality

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch No	Manufacturer
Ketovet 100mg Injection (Veterinary Use) Reg.No 102014	Ketoprofen	Batch No. 2324108 Mfg. Date: 10-23 Exp. date: 09-25	M/s Vetz Pharmaceutical (Pvt) Ltd. Kotri

Action Initiated	-The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and veterinary pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase surveillance in the market to ensure the effective recall of defective products(s). -Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk. -Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Veterinary Healthcare Professionals	DRAP requests increased vigilance within the supply chains of veterinary pharmacies and facilities likely to be affected by this faulty batch.
Advice for Consumers	-All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

Recall Alert: Drug Product; Espezar 20mg Tablets (Batch # A401) by Avant Pharmaceutical Pvt. Ltd, Hub, Baluchistan

Asad Ullah Recall Alerts December 21, 2023December 21, 2023

Recall Alert

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DRAP Alert No	N^oI/S/11-23-44
Action Date	21st Dec, 2023
Target Audience	· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc. · General Public
Problem / Issue	Federal Government Analyst, CDL Karachi has informed DRAP regarding the sample of product namely “Espezar tablet” Batch No. A401 manufactured by M/s. Avant Pharmaceuticals (Pvt.) Ltd., Plot No. 28 Hub Industrial Estate, Hub Balochistan has been declared as of “Substandard” quality.

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch No	Manufacturer
Espezar 20mg Tablets Reg.No 102983	Esomeprazole	Batch No. A401 Mfg. Date: 11-22 Exp. date: 11-24	M/s Avant Pharmaceutical Pvt. Ltd, Hub, Baluchistan

Risk Statement:	Esomeprazole is used to treat certain stomach and oesophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid the stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Esomeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). Impact of use of substandard product may leads to sub optimal therapeutic effect which may cause therapy failure or other associated problems.
Action Initiated	-The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase surveillance in the market to ensure the effective recall of defective products(s). -Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk. -Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

Recall Alert: Drug Product; Sterile Water for Injection (Batch # B6-77) by ISIS Pharmaceutical & Chemical Works, Karachi

Asad Ullah Recall Alerts December 8, 2023December 8, 2023

Recall Alert

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DRAP Alert No	N^oI/S/11-23-43
Action Date	8th Dec, 2023
Target Audience	· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc. · General Public
Problem / Issue	Federal Government Analyst, CDL Karachi has informed DRAP regarding the sample of product namely “Sterile Water for Injection” Batch No. B6-77 manufactured by M/s. ISIS Pharmaceuticals & Chemical works, 25/1-4, Sector 12-C, North Karachi Industrial Area, Karachi, has been declared as of “Substandard” quality.

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch No	Manufacturer
Sterile Water for Injection Reg.No 048819	Sterile Water for Injection	Batch No: B6-77 Mfg. Date: August 2023 Exp. Date: August 2025	M/s. ISIS Pharmaceutical & Chemical Works, Karachi

Risk Statement:	Sterile water for injection is a sterile, non-pyrogenic, and isotonic solution of water that does not contain any additives. It is mainly used as a solvent or diluent for other parenteral drugs, such as antibiotics and administered intravenously, intramuscularly, or subcutaneously. Endotoxin is a toxic substance that can cause serious harm such as fever, inflammation, shock, coagulation, and immune suppression. Using endotoxin-contaminated water for injection can lead to life-threatening complications, especially if injected intravenously.
Action Initiated	-The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase surveillance in the market to ensure the effective recall of defective products(s). -Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk. -Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

Recall Alert: Drug Product; Dolor DS 100mg/5mL Suspension (Batch # 1236,1237 and 1238) by Adamjee Pharmaceutical, Karachi

Asad Ullah Recall Alerts December 6, 2023December 8, 2023

Recall Alert

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DRAP Alert No	N^oII/S/10-23-42
Action Date	30th Nov, 2023
Target Audience	· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc. · General Public
Problem / Issue	Federal Government Analyst, CDL Karachi has declared the03 Batches of product “Dolor DS Suspension” as of substandard quality. The detail of the affected product is as under:

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch No	Manufacturer
Dolor DS Suspension Reg.No 14451	Mefenamic Acid	Batch No1236, 1237, 1238 Mfg. Date: March 2023 Exp. Date: March 2025	M/s. Adamjee Pharmaceuticals (Pvt.) Ltd, Karachi

Risk Statement:	Mefenamic acid is used for the short-term relief of mild to moderate pain from various conditions such as headache, dental pain, menstrual cramps, and muscle aches. Inaccurate use of the product may lead to common side effects like skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. Impact of use of substandard product on basis of pH test may significantly altered the solubility and interfere with its absorption which may leads to sub optimal therapeutic effect.
Action Initiated	-The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase surveillance in the market to ensure the effective recall of defective products(s). -Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk. -Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

Recall Alert: Drug Product; Piperazine Elixer (Batch # L-085) by Swat Pharmaceuticals, Swat

Asad Ullah Recall Alerts November 24, 2023November 27, 2023

Recall Alert

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DRAP Alert No	N^oII/S/10-23-41
Action Date	20th Nov, 2023
Target Audience	· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc. · General Public
Problem / Issue	Federal Government Analyst, CDL Karachi has declared the Batch No. L085 of product “Piperazine Elixer” as of substandard quality.

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch No	Manufacturer
Piperazine 750mg/5ml Elixir Reg.No 002235	Piperazine Citrate	Batch No L-085 Mfg. Date: June 2023 Exp. Date: May 2025	Ms. Swat Pharmaceuticals, Saidu Sharif Swat.

Risk Statement:	Piperazine Citrate is used to treat common roundworms (ascariasis) and pinworms (enterobiasis; oxyuriasis). To avoid the common side effects of gastrointestinal disturbances, headache, dizziness, and urticaria, it is important to use the product accurately. It is critical to ensure that the product is not substandard, as its use can significantly alter the dose and lead to suboptimal therapeutic effects.
Action Initiated	-The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase surveillance in the market to ensure the effective recall of defective products(s). -Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk. -Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

Recall Alert; Drug Product: Recall of Liquid Preparations for Suspected Contamination of DEG/EG Impurities by M/s Pharmix Laboratories, Lahore

Asad Ullah Recall Alerts November 16, 2023November 16, 2023

Recall Alert

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DRAP Alert No	N^oI/S/11-23-40
Action Date	16th November 2023
Target Audience	· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc. · General Public
Problem / Issue	DRAP has issued a recall of certain batches of liquid preparations due to suspected contamination with diethylene glycol (DEG) and ethylene glycol (EG). WHO has also informed the suspected presence of DEG/EG impurities in batch No. B220 of Alergo Syrup, (identified in the Maldives) which was manufactured by M/s. Pharmix Laboratories (Pvt.) Ltd., Lahore. Following a preliminary investigation conducted by DRAP Lahore, it is suspected that these impurities may also be present in other batches and products mentioned below. This recall is a precautionary measure taken to safeguard public health against the potential harmful effects of these impurities

Therapeutic Good(s) Affected: –

Product Names	Batch No	Manufacturer
Mucorid Syrup	A230, C227, A211, A212, B201, L111, A210, A230, B224, L121, C210, B201, B225	M/s. Pharmix Laboratories (Pvt.) Ltd., 21-Km Ferozpur Road, Lahore.
Ulcofin Suspension	B209, C223	-do-
Alergo syrup	B220, L126	do-
Emidone Suspension	B227	do-
Zincell Syrup	C218	do-

Risk Statement:	Between 2022 and 2023, several countries reported incidents of oral liquid drugs that were intended for children and were found to be contaminated with high levels of DEG and EG. These incidents lead to severe adverse events and fatalities in few countries.
Action Initiated	-The manufacturing company has been directed to immediately recall the defective batches of the above-mentioned products from the market. All pharmacists and chemists working at distributions and pharmacies are hereby advised to immediately check their stocks and stop supplying these batches of suspected products. The remaining stock should be quarantined and returned to the supplier/ company. -Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk. -Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using this product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.