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Rapid Alert: Drug Product Recall: Incidents of loss and damage of vision with the off-label use of Avastin 100mg/4ml injection

Yasir Mahmood Recall Alerts , ,

Information Update on 3rd Nov, 2023: The recall of Avastin 100mg/4ml has been terminated based on the report of Central Drugs Laboratory, Karachi which declared the samples as of standard quality.

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Rapid Alert

DRAP Alert NoNo  I/S/09-24-36
Action DateSeptember 24, 2023
Target Audience1. Ophthalmologists and Endocrinologists
2. Healthcare Professionals – Physicians, Pharmacists, and Nurses.
3. Regulatory Field Force.
4. General Public
Problem StatementIncidents of loss of vision in diabetic patients have been reported following treatment with Altered/Dispensed/Diluted Avastin injection. This product is approved by the Drug Regulatory Authority of Pakistan (DRAP) to treat Colorectal and other metastatic carcinomas. The use of this drug product in diabetic retinopathy or other ophthalmic conditions is one of the off-label uses and is not approved by DRAP.

The incident is linked with the alteration/dispensing/dilution and sale of Avastin 100mg/4mL Injection under unhygienic/non-sterile conditions illegally and without any Drug Sale/Dispensing License (DSL) from Provincial Health Authority by M/s Genius Advanced Pharmaceutical Services Lahore.
Threats to Public HealthAvastin is a registered drug of M/s. Roche Pharma in Pakistan and is available in strength of 100mg/4ml and 400mg/16ml preparations. This drug is indicated for the treatment of colorectal and other metastatic carcinomas as a VGRF (vascular endothelial growth factor) inhibitor.

However, the use in diabetic retinopathy is an off-label use to block the growth of abnormal blood vessels in the eye. Since this drug was being dispensed/diluted/repacked in 1.25mg/0.05ml dose under unhygienic conditions and in an unapproved manner, therefore, its safety cannot be ascertained which may lead to damage and loss of vision in the patients.

The product identification details are as under: –

Therapeutic Goods Affected:-

Following is the detail of the alleged product:

Product InvolvedManufacturer
Inj. Avastin 1.25 mg/0.05ml

Composition: Bevacizumab
Registration No. Nil		Genius Advanced
Pharmaceutical Services.
Un-registered Product

Following is the detail of DRAP approved product:

Product NameSuspected BatchManufacturer/Importer
Avastin 100mg/4ml Injection


Composition: Bevacizumab
Registration No. 043004		H0352B11
B7266B20
B7266B07		M/s Roche Diagnostics, Germany


Importer:
M/s Roche Pharma, Karachi.
Registered Product
Action InitiatedThe Regulatory field force raided the premises of M/s Genius Advanced Pharmaceutical Services, Lahore, involved in the repacking and dispensing of Avastin injection under unhygienic/non-sterile conditions. The premises have been sealed and legal proceedings have been initiated against the personnel involved.

The Importer of the registered product has been directed to recall the suspected batches of Avastin 100mg injection from the marked immediately. The sale/distribution of registered Avastin Injection has been put on halt till verification of its quality through sampling and laboratory testing to safeguard public health. Healthcare Professionals, Pharmacists and Chemists have been directed to stop the distribution, dispensing and administration of this product immediately, and check their stocks and stop supplying this product. The remaining stocks should be quarantined and returned to the supplier/company.
Advice for Healthcare Professionals-DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities regarding the off-label use of this product.

-Adverse reactions or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for ConsumersPatients should not use this product for any ophthalmic disease and should 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.

Rapid Alert: Falsified Sildenafil Citrate 100mg Tablets identified in the market

Asad Ullah Recall Alerts , , , ,

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

Asad Ullah Recall Alerts ,

Recall Alert

DRAP Alert NoNoI/S/02-23-12
Action Date21st 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 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-AlertDownload

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

    Asad Ullah Product Recalls, Recall Alerts, Safety Info , , , , , , ,

    Rapid Alert

    Urgent Recall of Suspected Product for contamination of DEG / EG

    DRAP Alert NoNoI/S/02-23-8
    Action Date20th February 2023
    Target Audience1. 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 StatementMedical 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:-

    SrProduct NameCompositionBatch #Manufactured by (as stated on label)
    1Bromgen Syp 100mL

    (Reg. Export Only)    		Bromhexine HClL392M/s Davis Pharmaceutical Laboratories,
    Islamabad-Pakistan
    2Kof Relief Syp 100mL
     
    (Reg, Export Only)    		Chlorpheniramine Maleate
    Ammonium Chloride
    Sodium Citrate
    Menthol
    Green Banana Flavour    		L394-do-
    3Macofen Syp 100mL
     
    (Reg, Export Only)    		IbuprofenL395-do-
    4Vomitil Suspension 120mL

    (Reg, Export Only)    		DomperidoneL400, L408,
    L414,    		-do-
    5Asperfin Syp 60mLKetotifenL401-do
    6Davis 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-
    7Zinc Syp 60mLZinc Sulphate MonohydrateCS06, CS36,
    CS37, CS38,
    CS39, CS45,
    CS46, CS47,
    CS48, CS60,
    CS75, CS76,
    CS80, CS81,
    CS83, CS92,
    CS93    		-do-
    Action InitiatedThe 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-ProductsDownload