Recall Alert: Medical Devices; Aquavent Neonatal Breathing Circuits by M/s. Armstrong Medical Limited, Ireland

Recall Alert

DRAP Alert NoNo I/V/05-23-23
Action Date17th May 2023
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
Product(s) Affected AQUAVENT NEO Neonatal CPAP limb
(Ventilator breathing circuit)
Manufactured by: Armstrong Medical Limited, Northern Ireland, Distributed by M/s. Elate C.C (Pvt) Ltd. Karachi, Pakistan
Batch No. 230123 (230123 as per the list in the Field Safety Notice)
Problem / Issue Armstrong Medical Limited, Ireland received reports for their Neonatal Breathing Circuits for risk of patient harm as a result of tubing (and a connector attached to the tubing) disconnecting from the elbow within Neonatal Breathing Circuits. Accordingly, the manufacturing company has issued a field safety notice and initiated recall of the defective product from the international market including Pakistan. 
Action Initiated-The manufacturing company has initiated a recall of the affected lots of defective products from the market where it was distributed.

-All healthcare professionals working in critical care units of hospitals as well as pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these lots of the product. 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 gsmsdra.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 this product’s defective batch(es) 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). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this Medical Device.

-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: Falsified Sildenafil Citrate 100mg Tablets identified in the market

Rapid Alert

Falsified and Unregistered Sildenafil Citrate 100mg Tablets

DRAP Alert NoNoI/S/02-23-18
Action Date3rd May 2023
Target Audience1. Regulatory Field Force
2. Pharmacists and Chemists at Distribution, Pharmacies and, Medical Stores
3. General Public
Problem StatementFederal Inspector of Drugs Karachi seized a sample of an unregistered product “Viagra 100mg Tablet” from the market and also sent the samples to Central Drug Laboratory, Karachi for testing/analysis. Federal Government Analyst has declared the sample as Spurious under section 3(z-b) (i) of the Drugs Act 1976.

The product detail as mentioned on the label is as under: –

Therapeutic Goods Affected:-

SrProduct NameComposition as per labelBatch #Manufactured by (as stated on label)
1Viagra 100mg Tablets

Mfg. Date: 03-2021
Exp. date:  03-2025
Sildenafil Citrate19990544AGMs. Brooklyn, Ne.
* Tablet Viagra sold in the black market is not registered with DRAP, hence considered Spurious /Falsified and unregistered, and its Quality, Safety, and Efficacy are not ascertained, hence its consumption may be harmful.
Risk Statement:Consequences of the use of unregistered, Spurious/ Falsified Drugs include but are not limited to the followings:
·     Falsified/Spurious drugs may contain toxic ingredients which are manufactured under unhygienic conditions without the proper inspection and approval of the product, which are highly injurious to human health.
·     Poor-quality medicines compromise the treatment of diseases and may intensify the existing condition.
Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product.
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 ConsumersConsumers should not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product 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; Fluorazine 1mg Tablet (Batch # T-2065) CKD Pharmaceuticals Pak (Pvt) Ltd, Karachi

Recall Alert

DRAP Alert NoNoI/S/04-23-20
Action Date11th April 2023
Target Audience1. 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 Fluorazine 1mg Tablets
Composition: Trifluoperazine HCl
Manufactured by: M/s. CKD Pharmaceutical, Karachi
Batch No. 2040006
Problem / Issue Provincial Drug Inspector, Karachi took the sample of Fluorazine 1mg Tablet. Provincial Government Analyst/Director, Drug Testing Laboratory, Karachi has declared the Batch No. T-2065 of the product as of substandard quality.
Action Initiated-The manufacturing company/registration holder has been directed to immediately recall the defective product batch 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 gsmsdra.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 this product’s defective batch(es) 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). They shall contact 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: Drug Product; Spadix Injection (Batch# 570) by M/s. Tabros Pharma Karachi

Recall Alert

DRAP Alert NoNoI/S/20-23-21
Action Date20th April 2023
Target Audience1. 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 StatementDrug 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 gsmsdra.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: Drug Product; Micogen-B Cream (Batch#MB-012/22) by M/s. Delux Chemical Industries, Karachi

Recall Alert

DRAP Alert NoNoII/S/03-23-17
Action Date27th March 2023
Target Audience1. 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 StatementDrug 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 gsmsdra.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: Drug Product; Mefco 50mg/5ml Suspension (Batch# 2J041) by M/s. Eros Pharmaceuticals (Pvt) Ltd., Karachi

Recall Alert

DRAP Alert NoNoII/S/03-23-19
Action Date29th March 2023
Target Audience1. 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 StatementMefenamic 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 gsmsdra.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: Drug Product; Opth-Carb Sterile Intraocular Solution (Batch#OP154) by M/s Opth Pharma (Pvt) Ltd., Karachi.

Recall Alert

DRAP Alert NoNoI/S/03-23-16
Action Date9th March 2023
Target Audience1. 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 StatementCarbachol 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 gsmsdra.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.

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

Safety Alert

Update from WHO Global Surveillance and Monitoring System

Date:28th February 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 IssueWorld 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.

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.

Recall Alert

DRAP Alert NoNoI/S/02-23-14
Action Date24th February 2023
Target Audience1. 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 StatementOscal-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 gsmsdra.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: Drug Product; Calcium Gluconate Injection (Batch # 220325) by M/s Shaheen Agency Karachi

Recall Alert

DRAP Alert NoNoI/S/02-23-11
Action Date23rd February 2023.
Target Audience1. 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 Statementinjection 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 gsmsdra.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.