Rapid Alert
| DRAP Alert No | No I/S/09-23-35 |
| Action Date | September 22, 2023 |
| Target Audience | 1. Regulatory Field Force 2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores 3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc. 4. General Public |
| Problem Statement | The Regulatory field force has Identified two spurious brands of Anti-D immunoglobulin injections in the market which are not legally imported into Pakistan. The identified brands include Hyp-Rho-D purported to be manufactured by M/s. Woolmar Chemical Corporation USA and distributed by M/s. Zaryab Traders Lahore, and Rhocolone® 300 mcg purported to be manufactured by M/s. Bharat Serums and Vaccines Limited, India. The manufacturer and stated distributor of Hyp-Rho-D injection is unknown and has no legal status in the supply chain of drugs. Secondly, the authorized distributor of M/s. Bharat Serums and Vaccines Limited India i.e. M/s. Hakimsons (impex) (Private) Ltd., Karachi have informed us that their principal company has not supplied any batch of product Rhocolne 300mcg to Pakistan. |
The product details are as under: –
Therapeutic Goods Affected:-
| Sr | Product Name | Composition | Batch # | Mfg. Date | Exp. Date | Manufactured by (as stated on the label) |
|---|---|---|---|---|---|---|
| 1 | Hyp-Rho-D Injection Registration No: Nil | Rho (D) immunoglobulin (Human) for injection | 09181943 | — | Jan-2025 | M/s. Woolmar Chemical Corporation, USA. Importer / Distributor: Ms. Zaryab Traders Lahore. |
| 2 | Rhocolne 300mcg Injection Registration No: Nil | Rho (D) immunoglobulin (Human) for injection | 39VAN0065 | 05.11.2022 | 05.11.2022 | Bharat Serums & Vaccines Limited, India. |
| Risk Statement: | The product claimed to contain immune globulin (anti-D immune globulin or RhIG), which is a commercial biological antibody derived from human plasma that targets red blood cells (RBCs) positive for the Rh (D) antigen (also referred to as the D antigen). It is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. Both of these products are unregistered which infers that the quality and safety attributes of the product are not accepted and approved by DRAP. Unregistered Injectable products may cause severe and lethal adverse effects as the safety and quality attributes of the product are unknown. |
| Action Initiated | The Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate these products. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product. |
| Advice for Healthcare Professionals | -DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these products. -Adverse reactions or quality problems experienced with the use of these products shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using 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 not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using these products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt. |