DRAP Recall Alert⚠️: Multiple Substandard & Adulterated Batches of Common Medications are Recalled by DRAP as CLASS-II & CLASS-I recalls

DRAP Recall Alert (Class-II)

Recall class-II is a situation where the use of or exposure to a violative or defective product can cause temporary or medically reversible health damage to a living being

DRAP Alert No: II/S/02-26-02
Action Date: 12 February 2025
Declared by: Drug Testing Laboratories (DTL), Punjab

Problem / Issue

Drug Testing Laboratories of Punjab Province have reported that the following drug products have been declared “Substandard” and/or “Adulterated.”

Therapeutic Goods Affected

Tablet Ascard-75 (Each enteric coated tablet contains Acetylsalicylic Acid [Aspirin] 75mg) (Reg. # 016600)
- Batches: AR065L, AR047L
- Manufacturer: M/s Atco Laboratories Limited, B-18 S.I.T.E Karachi (DML # 000188)
- Issue: Declared Substandard due to failure in test for Related Substances.
Tablet Daisy 10 mg (Each film coated tablet contains Cetirizine dihydrochloride USP 10mg) (Reg. # 032865)
- Batch: 24F213
- Manufacturer: M/s Mega Pharmaceuticals Ltd., 27 Km Raiwind Road, Lahore (DML # 000537)
- Issue: Declared Substandard based on Impurities test failure.
Tablet Sapizine 10 mg (Each tablet contains Cetirizine Dihydrochloride 10mg) (Reg. # 054261)
- Batch: 13098
- Manufacturer: M/s Sapient Pharma, 123-S Industrial Area Kot Lakhpat, Lahore (DML # 000207)
- Issue: Declared Substandard with respect to Impurities test failure.
Tablet Rozen 10 mg (Each tablet contains Cetirizine Dihydrochloride 10mg) (Reg. # 040161)
- Batch: 5F006
- Manufacturer: M/s Rasco Pharma (Pvt) Ltd., 5.5 Km Raiwind Road Ali Razabad, Lahore (DML # 000530)
- Issue: Declared Substandard based on Impurities test failure.
Cream Kanadex-N (Each gram contains Dexamethasone-21 phosphate as disodium salt 1mg and Neomycin sulphate 3500 I.U) (Reg. # 012475)
- Batches: 17-54, C8-26
- Manufacturer: M/s ISIS Pharmaceutical & Chemical Works, 25/1-3 Sector 12-C North Karachi Industrial Area, Karachi (DML # 000126)
- Issue: Declared Substandard due to failure in Assay of Dexamethasone Phosphate (as disodium salt) and Adulterated due to identification and quantification of undeclared Dexamethasone (base) in HPLC analysis, which is not stated on the product label.

Risk Statement

These products pose a moderate to high public health risk, particularly affecting outpatients such as cardiac patients, allergy sufferers, children, and individuals on long-term therapy.

Substandard Ascard-75 with excessive related substances may increase the risk of gastrointestinal irritation, bleeding, or reduced cardiovascular protection in patients using it for prevention of heart attack or stroke.

Cetirizine products failing impurity tests may expose patients, especially children and individuals with liver or kidney compromise, to unexpected toxic effects or reduced safety margins.

The most serious concern is Kanadex-N cream, where the presence of an undeclared corticosteroid base may result in skin thinning, hormonal suppression, masking of infections, and significant harm in infants or prolonged users, particularly among dermatology patients and individuals practicing self-medication.

DRAP Recall Alert (Class-I)

Recall Class-I is a situation where there is enough evidence that the use of or exposure to a defective product can induce serious or permanent heatlh damage to the person or it even can cause death

DRAP Alert No: I/S/02-26-01
Action Date: 12 February 2025
Declared by: Drug Testing Laboratories (DTL), Punjab

Problem / Issue

Drug Testing Laboratories of Punjab Province have reported that the following drug products have been declared “Substandard” and/or “Adulterated.”

Therapeutic Goods Affected

PSOL 2 ml – Sterile Water for Injection (Reg. # 098431)
- Batch: AK144
- Manufacturer: M/s Pharmasol (Pvt) Ltd., Plot 549, Sunder Industrial Estate, Lahore (DML # 000872)
- Issue: Declared Substandard due to failure in the Endotoxin test.
Nafen Ophthalmic Suspension (Each ml contains Nepafenac 1 mg) (Reg. # 075907)
- Batch: 4231
- Manufacturer: M/s Helix Pharma (Pvt) Ltd., A/56 SITE Mangopir, Karachi (DML # 000030)
- Issue: Declared Substandard based on Sterility test failure.
Metrorise Infusion (Metronidazole 500mg/100ml) (Reg. # 040412-D)
- Batch: LV-2506
- Manufacturer: M/s Pak Risen Pharmaceuticals, Plot No. 3 Block B Phase-I-II Industrial Estate, Hattar (DML # 000573)
- Issue: Declared Substandard due to failure in Bacterial Endotoxin Test and presence of visible particles.
Metroin Infusion IV (Metronidazole 500mg/100ml) (Reg. # 071279)
- Batch: MT25-331
- Manufacturer: M/s Saturn Pharmaceuticals (Pvt) Ltd., 23-Km Thokar Raiwind Road, Lahore (DML # 000734)
- Issue: Declared Substandard based on Bacterial Endotoxin Test failure.
Satamin Injection (Mecobalamin 500mcg) (Reg. # 071284)
- Batches: MC24-022, MC24-023, MC24-026, MC25-001
- Manufacturer: M/s Saturn Pharmaceuticals (Pvt) Ltd., 23-Km Thokar Raiwind Road, Lahore (DML # 000734)
- Issue: Declared Substandard due to Assay test failure and Adulterated based on Quantification of Cyanocobalamin.

Risk Statement

These findings pose a high public health risk, particularly to hospitalized and vulnerable patients including neonates, children, elderly individuals, immunocompromised patients, post-surgical cases, and those receiving IV or ophthalmic therapy.

Substandard sterile water and infusions that fail endotoxin or sterility tests may cause serious bloodstream infections, septic shock, pyrogenic reactions, and potentially fatalities, especially in intensive care settings. Visible particles increase the risk of embolic or inflammatory complications.

In the case of Satamin injection, adulteration and incorrect potency may lead to therapeutic failure, delayed neurological recovery, or unexpected adverse effects. These risks are particularly critical in emergency and clinical care environments where sterile injectables are essential.

Actions Taken

The Regulatory Field Force has been instructed to conduct surveillance and seize the above-mentioned substandard & adulterated batches of all medications.

Pharmacists, chemists, distributors, and healthcare professionals must urgently inspect their stocks. Details of suppliers of such products should be reported to the Regulatory Field Force (DRAP and Provincial Drug Control Departments) to ensure removal from circulation.

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 by Email at gsms@dra.gov.pk.

Guidance for Healthcare Professionals

Any adverse events or quality concerns linked to these medicines should be reported to the National or Provincial Pharmacovigilance Centres via the Adverse Event Reporting Form or through the official online portal.

How to download VigiMobile App for ADRs reporting

Guidance for Consumers

Consumers must avoid this product. If anyone experiences health problems after using them, they should immediately consult a healthcare provider and report the incident to DRAP / the National Pharmacovigilance Centre.

Always purchase therapeutic goods only from licensed pharmacies or authorized outlets. Carefully check the authenticity and condition of products, and consult a pharmacist or healthcare professional in case of doubt.

References:

Drug Regulatory Authority of Pakistan. (2026, February 12). 02. Recall Alert (Class-II) – Drug products tested by DTL Punjab. https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/02-recall-alert-class-ii-drug-products-tested-by-dtl-punjab/

Drug Regulatory Authority of Pakistan. (2026, February 12). 01. Recall Alert (Class-I) – Drug products tested by DTL Punjab. https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/01-recall-alert-class-i-drug-products-tested-by-dtl-punjab/

Drug Regulatory Authority of Pakistan. (2022, February 22). Recalls and rapid alerts – Rapid alert system. https://www.dra.gov.pk/safety-information/product-recalls/rapid-alert-system/