LAHORE: Pakistan’s drug regulatory authorities in Punjab have issued a Class-I recall of a batch of Injection Rhophylac 300 (Human Anti-D Immunoglobulin) after it was declared substandard due to sterility test concerns, according to an official public notice issued by the Directorate of Drugs Control (DDC), Punjab.
The alert, classified as DDCP Alert No. 64/2026 dated May 20, 2026, states that the Drug Testing Laboratory Punjab identified the product as substandard, prompting the Provincial Quality Control Board to order an immediate recall from the market.
The recalled product is Injection Rhophylac 300 (2 mL), containing Human Anti-D (Rh) Immunoglobulin, used in the prevention of Rh immunization in specific clinical conditions. The affected batch referenced in the notice is Reg. No. 041161 | P10080575 (Exp: Feb 2028).
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The product is purportedly manufactured by CSL Behring AG, Switzerland, and distributed in Pakistan by Hakimsons (Impex) Pvt. Ltd, Karachi, according to the official notification.
Authorities said the batch has been flagged as “substandard” specifically due to failure in sterility testing — a critical quality parameter for injectable biological medicines where contamination can pose serious health risks.
Under the directive, all marketing authorization holders and distributors have been instructed to immediately initiate a full recall of the affected batch from the supply chain. They must also submit distribution records, upload recall documentation to the Drug Regulatory Authority of Pakistan (DRAP) portal, and conduct a full root cause analysis along with a Corrective and Preventive Action (CAPA) plan.
Healthcare providers, pharmacies, wholesalers, and medical stores have been directed to stop dispensing the affected batch immediately and report existing inventory to local drug inspectors.
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Provincial field teams have been instructed to intensify market surveillance and ensure complete traceability of the product under the Drugs Act 1976 and DRAP Act 2012. Compliance reports are to be submitted to the Chief Drugs Controller Punjab.
Patients and consumers have been advised to discontinue use of the affected batch immediately and seek medical guidance if any adverse reaction is observed. Adverse events can be reported to the Provincial Pharmacovigilance Centre through official reporting channels.
Officials noted that Class-I recalls are reserved for products that may pose serious or life-threatening risks, highlighting the significance of the sterility concern identified in this case.
Rhophylac 300 is widely used in obstetric and clinical settings to prevent Rh incompatibility complications, making sterility assurance particularly critical for its safe use.
The recall comes amid increased regulatory scrutiny of injectable medicines and biological products in Pakistan, as authorities continue strengthening pharmacovigilance systems and supply chain monitoring under national drug safety frameworks.
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