Recall Alerts – Page 2 – Drug Regulatory Authority of Pakistan

Recall Alert: Drug Product; Chloroquine Injection (Batch # 201238) by M/s Mehran International Karachi

Asad Ullah Recall Alerts February 27, 2023March 6, 2023

Recall Alert

DRAP Alert No	N^oI/S/02-23-12
Action Date	23^rd February 2023.
Target Audience	1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions 3. General Public
Product(s) Affected	Chloroquine Injection Company: Importer Name; M/s. Mehran International, Karachi , Manufactured by: M/s. Shanxi Shuguana Pharma Co Ltd, China Batch No. 201238 Manufacturing Date: 12-2020 Expiry Date: 12-2023
Problem / Issue	Drug inspector Quetta took the sample of Chloroquine 5ml Injection Bach No. 201238 which has declared as Misbranded by Provincial Drug Testing Laboratory, Quetta.
Risk Statement	Chloroquine is used to prevent and treat of Malaria and Amebiasis. Improper labels due to delible printing of label may lead to misleading information, accidentally administering the wrong medication or wrong dose, may cause a patient to experience a negative health outcome. Further it may lead to adverse reactions including but not limited to Allergic reactions, Cardiac effects, Nausea, Vomiting, Abdominal cramps, Headache, and Diarrhea.
Action Initiated	-The sole agent / registration holder has been directed to immediately recall the defected 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 quarantine and return to the supplier / company. -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or 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 increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company. -Adverse reactions or quality problems experienced with the use of this product may 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 stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product. -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.

Recall-Alert-Chloroquine-Inj Download

Rapid Alert: Falsified / Spurious Cilapen 500mg Injection identified in the market

Asad Ullah Recall Alerts February 27, 2023March 6, 2023

Rapid Alert

Falsified / Spurious Cilapen 500mg Injection

DRAP Alert No	N^oI/S/02-23-13
Action Date	21^st February 2023
Target Audience	1. Regulatory Field Force 2. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Institutions 4. General Public
Problem Statement	Federal Inspector of Drugs Karachi took the sample of Cilapen 500mg Injection and sent to Central Drug Laboratory, Karachi for test/analysis. Federal Government Analyst has declared the sample as Spurious under section 3(z-b) (ii) of the Drugs Act 1976. The product detail as mentioned on the label is as under: –

Therapeutic Goods Affected:-

Sr	Product Name	Composition as per label	Batch #	Manufactured by (as stated on label)
1	Cilapen 500mg Injection Mfg. Date: 06-2022 Exp. date: 03-2024	Imipenem + Cilastatin	CP19014	Ms. Bosch Pharmaceuticals (Pvt.) Ltd., Karachi.

Following is the comparison of sample against the original pack of the product: –

S.N	Description	Original pack of the manufacturer (Bosch)	Sample pack (Spurious/Falsified)
1	Batch number for vial	CP19014	CP19014
2	Manufacturing date	11-2018	06-2022
3	Expiry date	10-2020	03-2024
4	M.R.P	Rs.810.90/=	Rs.1,140/=
5	Batch number of WFI on the ampoule and carton	Both same as WI19085	WI21042 on the ampoule where as WI19085 on the carton
6	Color of WFI ampoule	Blue	Orange
7	Printing of descriptions of product	Over-printing batch no. manufacturing date and expiry date	Plain printing (pre-printing)
8	Font size and style	As per standard approved Bosch Artwork.	Different from the company.
9	Direction insert/leaflet	As per standard approved Bosch Artwork.	Paper size and quality, color, printing is totally different from that of the company.

Risk Statement:	Imipenem and Cilastatin injection is used to treat certain serious infections that are caused by bacteria, including endocarditis and infection of respiratory tract, urinary tract, abdominal, gynecological, blood, skin, bone, and joint. Wrongful use / misleading information as mentioned above may leads to adverse reactions including but not limited to following: · Severe stomach pain, diarrhea that is watery or bloody. · Upper stomach pain, loss of appetite. · Jaundice and fever. · Seizure; light-headed feeling, like you might pass out. Consequences of use of Falsified/Spurious Drugs are: · Falsified/Spurious drugs may contain toxic doses of dangerous ingredients and cause mass poisoning. · Contributes to the progression of antimicrobial resistance and drug-resistant infections. · Poor-quality medicines compromise the treatment of chronic and infectious diseases, causing disease progression, drug resistance, and death.
Action Initiated	The Regulatory Field Force has been directed to increase the surveillance activities in the market to confiscate this batch of product. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this batch product. The remaining stock should be quarantine immediately, and supplier(s) information should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) in order to ensure the removal of this products.
Advice for Healthcare Professionals	-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned products. -Adverse reactions or quality problems experienced with the use of these product 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 STOP using these products and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product, and report the incident to Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. -All therapeutic goods must be obtained from the 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.

Rapid-Alert-Cilapen-500mg-Injection Download

Recall Alert: Drug Product; Hydralazine 25mg Tablets (Batch # 257) by M/s Zafa Pharmaceuticals (Pvt) Ltd, Karachi .

Asad Ullah Recall Alerts February 23, 2023February 23, 2023Alert, Recall

Recall Alert

DRAP Alert No	N^oI/S/02-23-12
Action Date	21^st February 2023.
Target Audience	1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions 3. General Public
Product(s) Affected	Hydralazine 25mg Tablets Active Ingredient(s): Hydralazine Company: M/s. Zafa Pharmaceuticals (Pvt) Ltd, Karachi. Batch No. 257 Manufacturing Date: 10-2022 Expiry Date: 10-2027
Problem / Issue	CDL Karachi has declared the batch No. 257 of Hydralazine 25mg Tablets, manufactured by M/s. Zafa Pharmaceuticals (Pvt) Ltd, Karachi. as substandard drug product.
Action Initiated	-The manufacturing company has been directed to immediately recall the defected 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 quarantine and return to the supplier / company. -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or 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 increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company. -Adverse reactions or quality problems experienced with the use of this product may 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 stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product. -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.

Hydralazine-25mg-Tab-Zafa-Recall-Alert Download

Rapid Alert: Urgent Recall of Suspected Products for Contamination of DEG / EG

Asad Ullah Product Recalls, Recall Alerts, Safety Info February 21, 2023February 22, 2023Alert, DRAP, HOTC, Pharnacovigilance, QA & LT, QualityDefects, RapidAlert, Recall

Rapid Alert

Urgent Recall of Suspected Product for contamination of DEG / EG

DRAP Alert No	N^oI/S/02-23-8
Action Date	20^th February 2023
Target Audience	1. Regulatory Field Force 2. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Institutions 4. General Public
Problem Statement	Medical Control Agency, Gambia has issued a Safety Alert Ref: – MCA/AD/23/MJK(029) dated 13th February,2023 for KOF Relief Syrup bearing Batch# L394, manufactured by M/s Davis Pharmaceutical Laboratories, Islamabad-Pakistan due to presence of Ethylene Glycol (EG) at unacceptable levels. DRAP Inspectorate has initiated the investigation based on this information, and decided to recall all the suspected products manufactured by the firm using the same source of excipient i.e Glycerin and Propylene Glycol (PG). The details of suspected contaminated products are as under: –

Therapeutic Goods Affected:-

Sr	Product Name	Composition	Batch #	Manufactured by (as stated on label)
1	Bromgen Syp 100mL (Reg. Export Only)	Bromhexine HCl	L392	M/s Davis Pharmaceutical Laboratories, Islamabad-Pakistan
2	Kof Relief Syp 100mL (Reg, Export Only)	Chlorpheniramine Maleate Ammonium Chloride Sodium Citrate Menthol Green Banana Flavour	L394	-do-
3	Macofen Syp 100mL (Reg, Export Only)	Ibuprofen	L395	-do-
4	Vomitil Suspension 120mL (Reg, Export Only)	Domperidone	L400, L408, L414,	-do-
5	Asperfin Syp 60mL	Ketotifen	L401	-do
6	Davis Tonic Syrup (250mL, 120ml)	Vitamin B12 Vitamin B1 HCl Vitamin B2 Vitamin B6 Vitamin B3 Folic Acid Vitamin B5 Sodium Glycerophosphate Manganese Sulphate Ferric Ammonium Citrate	CS07, CS20, CS21, CS23, CS30, CS31, CS42, CS70, CS71, CS159	-do-
7	Zinc Syp 60mL	Zinc Sulphate Monohydrate	CS06, CS36, CS37, CS38, CS39, CS45, CS46, CS47, CS48, CS60, CS75, CS76, CS80, CS81, CS83, CS92, CS93	-do-

Action Initiated	The manufacturing company has been directed to immediately recall the suspected batches of these products from the market. All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying these batches of products. The remaining stock should be quarantine and return to the supplier / company. Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned products. -Adverse reactions or quality problems experienced with the use of these product 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 STOP using these products and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product, and report the incident to Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. -All therapeutic goods must be obtained from the 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.

Davis-Rapid-Alert-of-Suspected-Contaminated-Products Download

Recall Alert: Drug Product; Capex 500mg Tablet (Batch# 2040006) by M/s. Rotex Pharma, Islamabad

Asad Ullah Recall Alerts February 20, 2023May 10, 2023

Recall Alert

DRAP Alert No	N^oI/S/04-23-23
Action Date	16^th February 2023
Target Audience	1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions 3. General Public
Product(s) Affected	Capex 500mg Tab Composition: Capacetiabine Manufactured by: M/s. Rotex Pharma, Islamabad Batch No. 2040006
Problem / Issue	A video circulating on social media regarding the presence of a fly/insect in a liquid injection ampoule visible with the naked eye, apparently seems to be having adulterated quality. The matter is still under investigation, however as a precautionary measure, to prevent any public health hazard, the alleged drug is being recalled from the market.
Risk Statement	Drug Product reported to contain a hair punch within the tablet is of adulterated quality which may compromise the quality of drugs
Action Initiated	-The manufacturing company/registration holder has been directed to immediately recall the defected batch of product from the market. -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this product batch. 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 increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer/company. -Adverse reactions or quality problems experienced with this product may 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 stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have experienced any problem that may be related to taking or using this product. -All drug 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-of-Capex Download

Recall Alert: Drug Product; Mefco 50mg/5mL Suspension (Batch # 21053) by M/s Eros Pharmaceuticals, (Pvt) Ltd, Karachi .

Asad Ullah Recall Alerts January 27, 2023January 27, 2023

Recall Alert

DRAP Alert No	N^oI/S/01-23-02
Action Date	23^rd January 2023
Target Audience	1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions 3. General Public
Product(s) Affected	Mefco 50mg/5mL Suspension, Active Ingredient(s): Mefenamic Acid Company: M/s. Eros Pharmaceuticals (Pvt) Ltd, Karachi. Batch No. 21053 Manufacturing Date: 09-2022 Expiry Date: 09-2024
Problem / Issue	CDL Karachi has declared the batch No. 21053 of Mefco 50mg/5mL Suspension, manufactured by M/s. Eros Pharmaceuticals (Pvt) Ltd, Karachi. as substandard drug product.
Action Initiated	-The manufacturing company has been directed to immediately recall the defected batch of product from the market. -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company. -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or 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 increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company. -Adverse reactions or quality problems experienced with the use of this product may 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 stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product. -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.

Mefco-50mg-Suspension-Eros-Pharma Download

Recall Alert: Drug Product; Santodex Opthalmic Ointment (Batch # BJ-082) by M/s Sante (Private) Limited, Karachi .

Asad Ullah Recall Alerts January 27, 2023February 7, 2023

Recall Alert

DRAP Alert No	N^oI/S/01-23-03
Action Date	23^rd January 2023
Target Audience	1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions 3. General Public
Product(s) Affected	Santodex Opthalmic Ointment, Active Ingredient(s): Tobramycin 3mg/g & dexamethasone 1mg/g Company: M/s. Sante (Private) Limited, Karachi Batch No. BJ-082 Manufacturing Date: 04-2022 Expiry Date: 04-2024
Problem / Issue	CDL Karachi has declared the batch No. BJ-082 of Santodex Opthalmic Ointment, manufactured by M/s. Sante (Private) Limited, Karachi as substandard drug product.
Action Initiated	-The manufacturing company has been directed to immediately recall the defected batch of product from the market. -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company. -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or 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 increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company. -Adverse reactions or quality problems experienced with the use of this product may 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 stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product. -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.

Santodex-oint-Recall-Alert Download

Recall Alert: Drug Product; Fenbar 50mg Tablets (Batch # 2752) by M/s Usawa Pharmaceuticals, Risalpur.

Asad Ullah Recall Alerts January 26, 2023January 27, 2023

Recall Alert

DRAP Alert No	N^oI/S/01-23-05
Action Date	25^th January 2023
Target Audience	1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions 3. General Public
Product(s) Affected	Fenbar 50mg Tablet, Active Ingredient(s): Diclofenac Sodium Company: M/s. Usawa Pharmaceuticals, Risalpur. Batch No. 2752 Manufacturing Date: 04-2022 Expiry Date: 04-2025
Problem / Issue	CDL Karachi has declared the batch No. 2752 of Fenbar 50mg Tablet manufactured by M/s.Usawa Pharmaceuticals, Risalpur as substandard drug product.
Action Initiated	-The manufacturing company has been directed to immediately recall the defected batch of product from the market. -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company. -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or 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 increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company. -Adverse reactions or quality problems experienced with the use of this product may 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 stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product. -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.

Fenbar-50mg-Tab-Recall-Usawa-Risalpur Download

Recall Alert: Drug Product; Paracet 1g/100mL Infusion by M/s Standpharm Pakistan Pvt Ltd, Lahore.

Asad Ullah Product Recalls, Recall Alerts, Safety Info January 9, 2023

Recall Alert

DRAP Alert No	N^oI/S/01-23-43
Action Date	3^rd January 2023
Target Audience	1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions 3. General Public
Product(s) Affected	Paracet 1g/100mL Infusion, Active Ingredient(s): Paracetamol Company: M/s. Standpharm Pakistan Pvt Ltd, Lahore Batch No. CIJI70 Manufacturing Date: 20-09-2022 Expiry Date: 20-09-2024
Problem / Issue	CDL Karachi has declared the batch No. CIJI70 of Paracet 1g/100ml Infusion manufactured by M/s. Standpharm Pakistan (Pvt.) Ltd., Lahore as substandard & adulterated drug product.
Action Initiated	-The manufacturing company has been directed to immediately recall the defected batch of product from the market. -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company. -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or 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 increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company. -Adverse reactions or quality problems experienced with the use of this product may 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 stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product. -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.

Paracet-1g-Inj-Standpharm Download

Voluntary Recall Alert: Drug Product; Cytotol 200mcg Tablets (Batch # 176,177,178,179,180) by M/s Saffron Pharmaceutical, Faisalabad

Asad Ullah Product Recalls, Recall Alerts, Safety Info December 22, 2022January 3, 2023

Voluntary Recall Alert

DRAP Alert No	N^oI/S/12-22-42
Action Date	20^th December 2022
Target Audience	1.Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 2.Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc. 3. General Public
Product(s) Affected	Cytotol 200mcg Tablets, Active Ingredient(s): Misoprostol Company: M/s. Saffron Pharmaceutical Faisalabad Batch No. 176,177,178,179,180
Problem / Issue	Saffron Pharmaceuticals (Pvt.) Limited has initiated a voluntary recall of batch No. 176,177,178,179,180 of their product “Cytotol 200mcg Tablet”.
Action Initiated	-The manufacturing company is recalling the defected batches of product from the market. -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company. -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or 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 increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company. -Adverse reactions or quality problems experienced with the use of this product may 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 stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product. -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.

Voluntary-Recall-of-Cytotol-200mcg-Tablets Download