Recall Alerts – Page 3 – Drug Regulatory Authority of Pakistan

Recall Alert: Drug Product; Spadix Injection (Batch# 570) by M/s. Tabros Pharma Karachi

Asad Ullah Recall Alerts April 20, 2023April 20, 2023DRAP, Patient Safety, QA & LT, QualityDefects, Recall

Recall Alert

DRAP Alert No	N^oI/S/20-23-21
Action Date	20^th April 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	Spadix 4mL Injection Composition: Phloroglucinol and Trimethylphloroglucinol Manufactured by: M/s. Tabros Pharma, (Pvt) Ltd., Karachi Batch No. 570
Problem / Issue	A video is circulating on social media regarding presence of a fly/insect in a liquid injection ampoule visible with 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 market.
Risk Statement	Drug Product contains fly/insect is of adulterated quality which may compromise the standard quality of drugs as not being sterile. The sterility is a basic quality attribute of all Injectable drugs. In this case such adulterated drug may initiate but not limited to following reaction in patients/users (i) Anaphylactic shock in patients which may lead to death of patient (ii) Skin rashes, itching, difficulty in breathing (iii) Sub optimal to no therapeutic effect for indicated medical treatment.
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 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-of-Spadix-Injectin Download

Recall Alert: Drug Product; Micogen-B Cream (Batch#MB-012/22) by M/s. Delux Chemical Industries, Karachi

Asad Ullah Recall Alerts April 5, 2023April 5, 2023

Recall Alert

DRAP Alert No	N^oII/S/03-23-17
Action Date	27^th March 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	Micogen-B Cream Composition: Gentamicin, Miconazole and Betamethasone Manufactured by: M/s. Delux Chemical Industries, Karachi Batch No. MB-012/22 Manufacturing Date: 11-2022 Expiry Date: 11-2024
Problem / Issue	Federal Government Analyst, CDL Karachi has declared the Batch No. MB-012/22 of the product “Micogen-B Cream” as of substandard quality.
Risk Statement	Drug Product contains multiple ingredients including Betamethasone, Gentamicin & Miconazole, is indicated for treatment of fungal and bacterial infections of the skin. Impact of use of substandard product on basis of Bio Assay test may leads to sub optimal to no therapeutic effect and may intensify/ flare the existing bacterial and fungal infection.
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 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.

Micogen-B-Cream-Batch-MB-012-22 Download

Recall Alert: Drug Product; Mefco 50mg/5ml Suspension (Batch# 2J041) by M/s. Eros Pharmaceuticals (Pvt) Ltd., Karachi

Asad Ullah Recall Alerts April 3, 2023April 11, 2023

Recall Alert

DRAP Alert No	N^oII/S/03-23-19
Action Date	29^th March 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 Composition: Mefenamic Acid Manufactured by: M/s. Eros Pharmaceutical (Pvt) Ltd., Karachi Batch No. 2J041 Manufacturing Date: 10-2022 Expiry Date: 10-2024
Problem / Issue	Federal Government Analyst, CDL Karachi has declared the Batch No. 2J041 of the product “Mefco 50mg/5ml Suspension” as of substandard quality.
Risk Statement	Mefenamic acid is used to treat mild to moderate pain. Impact of use of substandard product on basis of pH test may significantly altered the solubility and interfere with its absorption.
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 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.

Mefco-50mg-Suspension-batch-2J041-Eros-Pharma Download

Recall Alert: Drug Product; Opth-Carb Sterile Intraocular Solution (Batch#OP154) by M/s Opth Pharma (Pvt) Ltd., Karachi.

Asad Ullah Recall Alerts March 13, 2023March 17, 2023

Recall Alert

DRAP Alert No	N^oI/S/03-23-16
Action Date	9^th March 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	Ophth-Carb Sterile Intraocular Solution Manufactured by: M/s. Ophth Pharma (Pvt.) Ltd., Karachi Batch No. OP154 Manufacturing Date: 12-2022 Expiry Date: 11-2024
Problem / Issue	Federal Government Analyst, CDL Karachi has declared the Batch No. OP154 of product “Ophth-Carb Sterile Intraocular Solution” as of substandard quality.
Risk Statement	Carbachol is primarily used in the treatment of glaucoma, it is also used during ophthalmic surgery. All ophthalmic products must meet a number of requirements of safety and sterility and if the product is not sterile (free from bacteria or microorganisms), it may lead to serious infection which includes but not limited to redness of eyes, itching in eyes, watery discharge, blurred vision and loss of vision.
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.

Opth-Carb-Intraoculat-Soln-Recall-Alert Download

Safety Alert: WHO Global Alert on Tetracycline Hydrochloride Ophthalmic Ointment USP 1%

Asad Ullah Recall Alerts, Regulatory Updates, Safety Alerts March 6, 2023March 16, 2023

Safety Alert

Update from WHO Global Surveillance and Monitoring System

Date:	28^thFebruary 2023
Target Audience:	· Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc. · International travelers/General Public · NGO’s/Supply Donations/Humanitarian Medicines
Problem or Issue	World Health Organization (WHO) issued Medical Product Alert No. N°2/2023 dated 22nd February 2023 which refers to the batches of Tetracycline Hydrochloride Ophthalmic Ointment USP 1%, manufactured by Galentic Pharma (India) Pvt. Ltd, located at R-673, T.T.C. MIDC Rabale, Thane- Belapur Road, Navi Mumbai – 400701, Maharashtra, India Supplied in various countries under various labels. Visual examination of random samples had shown a range of quality issues with the random samples of the product batches e.g. particles ranging in color, size and shape on the nozzle, in the cap and in the ointment inside each tube, black spots and brown splotches on the inner foil layer of the tube, and phase separation. DRAP has never authorized sale of any products from Galentic Pharma (India) Pvt. Ltd (Thane Belapur Road, Navi Mumbai, India). These products are neither registered nor available on Pakistan market, however these may have been carried for personal use while visiting other countries. The manufacturer has initiated a voluntary recall for several batches. The manufacturer has indicated that other batches may be included in the voluntary recall
Potential Hazards:	There is currently no established evidence of any adverse events from the affected batches of TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1%. Redness and swollen eyes are common reactions to general use of tetracycline eye ointment. There is currently no indication that the above-mentioned quality issues may give rise to adverse events that are not listed in the product labelling. The affected TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1% is supplied in bulk and as a component of various medical kits supplied by some international organizations providing humanitarian assistance.
Advice for healthcare professionals:	DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this affected batch of product. Adverse reactions or quality problems experienced with the use of any product shall be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information of reporting problems to DRAP is available on this link.
Advice for patients:	Consumers should stop using this product bearing the affected batch number(s) 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.

Safety-Alert-for-Tetracycline Download

All therapeutic goods must be obtained from the licensed pharmacies, and other authorized retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professional in case of any doubt.

Recall Alert: Drug Product; Oscal-D Tablets (Batch # 6904) by M/s Aries Pharmaceuticals (Pvt) Ltd, Peshawar.

Asad Ullah Recall Alerts March 1, 2023March 6, 2023

Recall Alert

DRAP Alert No	N^oI/S/02-23-14
Action Date	24^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	Oscal-D Tablets Manufactured by: M/s. Aries Pharmaceuticals (Pvt) Ltd, Peshawar. Batch No. 6904 Manufacturing Date: 07-2022 Expiry Date: 07-2024
Problem / Issue	Federal Government Analyst, CDL Karachi has declared the Batch No. 6904 of product “Oscal-D Tablets” as of substandard quality.
Risk Statement	Oscal-D Tablets may be used to treat conditions caused by low calcium levels such as osteoporosis, osteomalacia/rickets, hypoparathyroidism and latent tetany. Inaccurate use of the product may lead to adverse reactions including but not limited to irregular heartbeat, weakness, drowsiness, headache, dry mouth or a metallic taste in your mouth or muscle or bone pain. Impact of use of substandard product on basis of assay test may leads to low to no therapeutic effect etc.
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-Oscal-D-tablets Download

Recall Alert: Drug Product; Calcium Gluconate Injection (Batch # 220325) by M/s Shaheen Agency Karachi

Asad Ullah Recall Alerts February 28, 2023March 6, 2023

Recall Alert

DRAP Alert No	N^oI/S/02-23-11
Action Date	23rd 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	Calcium Gluconate Injection Company: Importer Name; M/s. Shaheen Agency, Karachi , Manufactured by: M/s. China National M/H Shanghai China Batch No. 220325 Manufacturing Date: 03-2022 Expiry Date: 03-2025
Problem / Issue	Drug inspector Quetta took the sample of Calcium Gluconate Injection Batch no. 220325 which has declared as Misbranded by Provincial Drug Testing Laboratory, Quetta. Details of the product is given as under:
Risk Statement	injection Calcium gluconate is a lifesaving drug which is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Wrongful use /misleading information due to delible printing upon label of Injection Calcium Gluconate, may disturb the patient’s body calcium balance and may lead to adverse reactions including but not limited to following: (i) Arrhythmias with Concomitant Cardiac Glycoside Use. (ii) End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates. (iii) Tissue Necrosis and Calcinosis. (iv)Hypotension, Bradycardia, and Cardiac Arrhythmias.
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.

Calcium-Gluconate-Inj-Shaheen-Agency-Recall-Alert Download

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