Recall Alert: Drug Product; Water for Injection (Batch 989) by Zafa Pharmaceutical Pvt Ltd, Karachi

Recall Alert

DRAP Alert NoNo I/S/06-24-26
Action Date09th June 2024.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
– Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics
– General Public
Problem / Issue Federal Drug Inspector in Karachi collected a sample of Sterile Water for Injection and sent for laboratory analysis. Federal Government Analyst at CDL Karachi has declared Batch No. 989 of the product as substandard.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Sterile Water for Injection

Reg No. 030217
Water for InjectionBatch No. 989
Mfg Date:03-2023
Exp Date:03-2028
M/s. Zafa Pharmaceutical
Laboratories Private Limited Karachi.
Risk Statement:Using non-sterile water for reconstitution of injectable medications can lead to bacterial and fungal infections, and may cause poor dissolution of the powder. It could also result in precipitation or deactivation of the active pharmaceutical ingredient, posing significant health risks.
Action InitiatedThe manufacturer has been directed to immediately recall the defected batch of product from the market. All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) also increased surveillance in the market to ensure the effective recall of defective products(s).

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

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 ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.  

-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the
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 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 product.

-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.