DRAP’s Multiple Recalls Alerts About Adulterated, Substandard & Misbranded Medicines

Recall Alert (Class-I) – BP-NORM Tablets (Substandard & Adulterated)

DRAP Alert No: No I/S/01-26-133
Action Date: 21 January 2025

Issued By

Drug Regulatory Authority of Pakistan (DRAP) on the basis of findings from Drug Testing Laboratories, Punjab.

Target Audience

• National Regulatory Field Force

• Healthcare Professionals (Physicians, Pharmacists, Nurses)

• General Public

Reason for Recall

• Samples of the below-mentioned drug product were declared Substandard and Adulterated by Drug Testing Laboratories, Punjab.

Product Information

• Product name: BP-NORM Tablets

• Active ingredient: Atenolol 50 mg

• Batch number: 5968P485

• Drug Registration No.: 071447

• Manufacturer: M/s Neutro Pharma (Pvt.) Ltd.

• Manufacturing address: 9.5-Km Sheikhupura Road, Lahore

• Drug Manufacturing Licence (DML) No.: 000576

Laboratory Findings / Remarks

• Declared Substandard due to failed assay of Atenolol

• Declared Adulterated under Section 3(a)(v) of the Drugs Act, 1976

• Confirmed presence of an undeclared active ingredient: Ciprofloxacin HCl

Risk Statement

• Use of BP-NORM (Atenolol 50 mg), Batch No. 5968P485, poses a serious risk to public health

• Reduced atenolol content may lead to loss of blood pressure and cardiac control

• Undeclared Ciprofloxacin HCl may cause unexpected antibiotic exposure, adverse drug reactions, and drug interactions

• Risk of contributing to antimicrobial resistance, especially in elderly and cardiovascular patients

• Immediate recall and discontinuation are necessary to mitigate patient harm

 Recall Alert (Class-II) – Henafim Paediatric Suspension (Substandard)

DRAP Alert No: No II/S/01-26-134
Action Date: 14 January 2025

Issued By

Drug Regulatory Authority of Pakistan (DRAP) following test results from Central Drug Laboratory (CDL), Karachi.

Target Audience

• National Regulatory Field Force

• Healthcare Professionals

• General Public

Reason for Recall

• The product was declared Substandard based on assay testing by CDL Karachi.

Product Information

• Product name: Henafim Paediatric Suspension

• Composition per 5 mL:

  • Paracetamol 120 mg

  • Chlorpheniramine Maleate 1 mg

• Batch number: 558

• Drug Registration No.: 078545

• Manufacturer: M/s Wisdom Pharmaceutical Industry

• Manufacturing address: 78-A Industrial Estate, Hayatabad, Peshawar

• Drug Manufacturing Licence (DML) No.: 000780

Laboratory Findings / Remarks

• Paracetamol assay result: 71%

• Chlorpheniramine Maleate assay result: 81%

• Declared Substandard due to reduced potency of both active ingredients

Risk Statement

• Use of Henafim Paediatric Suspension, Batch No. 558, may result in inadequate fever control and poor relief of allergic symptoms

• Reduced potency may lead caregivers to administer repeated or higher doses, increasing the risk of misuse

• Although not adulterated, substandard quality compromises effective treatment in infants and children, a vulnerable population

• Regulatory action is required to ensure patient safety

 Rapid Alert – Unregistered OMNIVISC 2% Ophthalmic Solution (Substandard & Misbranded)

DRAP Alert No: No I/S/01-26-135
Action Date: 21 January 2026

Issued By

Drug Regulatory Authority of Pakistan (DRAP) based on reports from Drug Testing Laboratory, Punjab.

Target Audience

• DRAP and Provincial Drug Control Field Force

• Healthcare Professionals

• Pharmacies and Medical Stores

Reason for Rapid Alert

• The product was found Unregistered, Substandard, and Misbranded under the Drugs Act, 1976 and Drugs (Labeling & Packing) Rules, 1986.

Product Information (Batch-wise)

Omnivisc 2% (HPMC) Ophthalmic Solution USP, 5 mL

• Batch number: OMV190171

• Purported manufacturer: M/s Omni Lens Pvt. Ltd.

• Manufacturer address: Plot No. 17, Ambota, Sector-5, Parwanoo, Distt. Solan (H.P.), India

• Declared Substandard due to failed sterility test (Non-sterile)

• Declared Misbranded due to:

  • Mismatch of batch number on labels

  • Absence of Pakistan Drug Registration Number

  • Absence of Urdu usage instructions

  • Non-mentioning of Maximum Retail Price (MRP)

Omnivisc 2% (HPMC) Ophthalmic Solution USP, 5 mL

• Batch number: OMV191171

• Purported manufacturer: M/s Omni Lens Pvt. Ltd.

• Declared Substandard due to failed sterility test (Non-sterile)

• Declared Misbranded due to:

  • Absence of Pakistan Drug Registration Number

  • Incomplete labeling particulars

  • Missing Urdu instructions

  • Non-mentioning of Maximum Retail Price (MRP)

Risk Statement

• Use of Omnivisc 2% Ophthalmic Solution, Batches OMV190171 and OMV191171, poses a serious and vision-threatening risk

• Non-sterile ophthalmic products may cause severe ocular infections, including conjunctivitis, keratitis, corneal ulcers, and endophthalmitis

• Potential for irreversible vision impairment or blindness, particularly in post-surgical, contact lens, and immunocompromised patients

• Misbranding increases the risk of misuse, prolonged use, and delayed medical care

• Immediate withdrawal from the supply chain is necessary

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