Recall Alert
| DRAP Alert No | No I/S/06-25-48 |
| Action Date | 16th June, 2025. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | The Registration Board, in its 346th meeting held on 22nd April 2025, decided to ‘suspend’ registrations of products containing 17-Hydroxyprogesterone caproate, in light of the decision made by the Coordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh) of the European Medicine Agency (EMA). The details of the marketing authorization holders of the said molecule are provided below: |
Therapeutic Goods (s) Affected: –
| Product Names | Composition | Manufactured by |
|---|---|---|
| GLOBINAN INJECTION 1ML & 2ML Reg. No. 030525 & 030526 | Each ampoule contains: Hydroxyprogesterone caproate …..250mg | M/s Global Pharmaceuticals (Pvt.) Ltd., Plot No. 204-205, Industrial Triangle Kahuta Road, Islamabad. |
| HYDROXYPROGESTERONE INJECTION Reg. No. 003746 | Each ampoule contains: Hydroxyprogesterone caproate …..250mg | M/s Haji Medicines Co, Haji Yasin Block, Plot No. 206& 207, Industrial Triangle, Kahuta Road, Islamabad |
| NANDROSOL 250MG INJECTION Reg. No. 096479 | Each ampoule contains: Hydroxyprogesterone caproate …..250mg | M/s. Pharmasol (Pvt.) Ltd., Plot No. 549, Sundar Industrial Estate, Lahore. |
| HYGEST INJECTION Reg. No. 094205 | Each ampoule contains: Hydroxyprogesterone caproate …..250mg | M/s Shaigan Pharmaceuticals (Pvt.) Ltd, l4 Km, Adyala Road Post Office Daghal, Rawalpindi. |
| VIO-DEPOT INJECTION Reg. No. 013624 | Each ampoule contains: Hydroxyprogesterone caproate …..250mg | M/s. Venus Pharma, 23Km Multan Road Lahore, Lahore. |
| HYDROXYPROGESTERONE INJECTION Reg. No. 003531 | Each ampoule contains: Hydroxyprogesterone caproate …..250mg | M/s Zafa Pharmaceutical Laboratories (Pvt) Ltd., L-4/1, A&8, Block 21, F.B Industrial Area, Karachi. |
| Risk Statement: | A review by EMA’s safety committee, Pharmacovigilance Risk Assessment Committee (PRAC) concluded that there is a possible but unconfirmed risk of cancer in people exposed to 17-Hydroxyprogesterone Caproate in the womb. In addition, the review considered new studies which showed that the said product is not effective in preventing premature birth; there are also limited data on its effectiveness in other authorized uses. |
| Action Initiated | – The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined, and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product. –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. –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 Professionals | DRAP 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. |