DRAP RECALL ALERT: SUBSTANDARD AND ADULTERATED PRODUCTS IDENTIFIED BY CDL KARACHI

DRAP Alert No: I/S/01-26-130

Action Date: 14 January 2025

Problem / Issue

CDL Karachi has reported that samples of the following therapeutic products have been declared Substandard, Adulterated, or Misbranded following laboratory analysis.

Therapeutic Goods Affected

1. Injection Neocobal

   • Composition: Mecobalamin 0.5 mg/mL

   • Registration No.: 071447

   • Batch No.: S-2901

   • Manufacturer:
     M/s Pulse Pharmaceuticals (Pvt.) Ltd., Mozay Badoke, Raiwind Road, Lahore

   • DML No.: 000564

   • Remarks:
     Declared Substandard with respect to assay and Adulterated under Section 3(a)(v) of the Drugs Act, 1976.

2. Injection Kamedex (1 mL)

   • Composition: Each mL contains Dexamethasone Sodium Phosphate equivalent to Dexamethasone Phosphate 4 mg

   • Registration No.: 074983

   • Batch No.: DX-2485

   • Manufacturer:
     M/s Amaan Pharma, 30-Km Sheikhupura Road, Lahore

   • DML No.: 000808

   • Remarks:
     Declared Adulterated under Section 3(a)(v) of the Drugs Act, 1976, as laboratory analysis identified Dexamethasone base at a significantly lower level than claimed, rendering the label false and misleading.

3. Unisol NS Infusion 100 mL

   • Composition: Each 100 mL contains Sodium Chloride 0.9 g

   • Batch No.: 5109040

   • Manufacturer:
     M/s Unisa Pharmaceutical Industries Ltd., Main GT Road, Adamzai, Akora Khattak, District Nowshera

   • DML No.: 000740

   • Remarks:
     Declared Substandard on the basis of Bacterial Endotoxin Test (BET) failure.

4. Isobaj Injection 10 mL

   • Composition: Each mL contains Isosorbide Dinitrate 1 mg

   • Registration No.: 100721

   • Batch No.: IB-1125

   • Manufacturer:
     M/s Bajwa Pharmaceuticals (Pvt.) Ltd., 36-Km Lahore–Gujranwala Road, Sheikhupura

   • DML No.: 000805

   • Remarks:
     Declared Substandard on the basis of Bacterial Endotoxins Test (BET) and Misbranded under Section 3(s)(iv) of the Drugs Act, 1976, as the product does not comply with the BP monograph definition of “ready-to-use solution” while labeling states “must be diluted prior to use”.

5. ZEESOL-H Infusion (Ringer Lactate) 1000 mL

   • Composition:

     • Calcium Chloride 2H₂O — 0.27 g

     • Potassium Chloride — 0.40 g

     • Sodium Chloride — 6.00 g

     • Sodium Lactate — 3.20 g

     • Water for Injection q.s.

   • Registration No.: 019752

   • Batch No.: 2503281

   • Manufacturer:
     M/s Shazeb Pharmaceutical Industries Ltd., Hazara Trunk Road, Sarai Gadaee, District Haripur

   • DML No.: 000380

   • Remarks:
     Declared Substandard on the basis of Sterility Test failure.

6. Injection Neudex

   • Composition: Dexamethasone Sodium Phosphate equivalent to Dexamethasone Phosphate 4 mg/mL

   • Registration No.: 32876

   • Batch Nos.: DX079, DX080, DX064, DX060, DX042, DX063, DX072, DX067, DX068, DX070, DX065

   • Manufacturer:
     M/s Neutro Pharma (Pvt.) Ltd., 9.5-Km Sheikhupura Road, Lahore

   • DML No.: 000576

   • Remarks:
     Declared Adulterated under Section 3(a)(v) of the Drugs Act, 1976, as laboratory analysis revealed significantly lower Dexamethasone content than claimed, making the composition false and misleading.

7. Entagyl Oral Suspension 400 mL

   • Composition: Each 5 mL contains Benzoyl Metronidazole equivalent to Metronidazole BP 200 mg

   • Registration No.: 087947

   • Batch No.: 272

   • Manufacturer:
     M/s BJ Pharmaceuticals, Mandialai Stop, Bhattianwala Road, Lahore

   • DML No.: 000770

   • Remarks:
     Declared Substandard due to presence of Ethylene Glycol impurity above permissible limits.

Risk Statement

Substandard potency, adulteration, misleading labeling, and contamination with bacterial endotoxins or toxic impurities pose severe risks to patient safety, including:

• Treatment failure

• Toxic reactions

• Fever, shock, and sepsis

• Hormonal imbalance and steroid-related adverse effects

Patients at highest risk include hospitalized individuals, critically ill patients, children, pregnant women, and those receiving injectables, intravenous fluids, steroids, or vitamin B12 therapy, where even minor quality deviations may result in fatal outcomes.