DRAP RECALL ⚠️The PRODUCTS CONTAINING HYDROXYPROGESTERONE CAPROATE💉
DRAP (Drug regulatory authority of Pakistan has recalled and suspends the registration of the products containing hydroxyprogesterone caproate due to the possible but unconfirmed risk of cancer in the patients exposed to 17-Hydroxyprogesterone Caproate 💉 in the womb. The verdict of DRAP recall has been given in light of the decision made by the Coordination Group for Mutual Recognition and Decentralized Procedures – Human (CMDh) of the European Medicine Agency (EMA).
In addition to this, new research studies have shown that the said product is not effective in preventing premature birth; there are also limited data on its effectiveness in other authorized uses.
Following is the list of, 17-Hydroxyprogesterone Caproate containing Products, that has been recalled and suspended:
Product Names | Composition | Manufactured by |
GLOBINAN INJECTION 1ML & 2ML Reg. No. 030525 & 030526 | Each ampoule contains: | M/s Global Pharmaceuticals (Pvt.) Ltd., |
HYDROXYPROGESTERONE INJECTION Reg. No. 003746 | Each ampoule contains: | M/s Haji Medicines Co, |
NANDROSOL 250MG INJECTION Reg. No. 096479 | Each ampoule contains: | M/s. Pharmasol (Pvt.) Ltd., |
HYGEST INJECTION Reg. No. 094205 | Each ampoule contains: | M/s Shaigan Pharmaceuticals (Pvt.) Ltd, |
VIO-DEPOT INJECTION Reg. No. 013624 | Each ampoule contains: | M/s. Venus Pharma, |
👩💼Directions for Regulatory department regarding DRAP recall:
DRAP’s regulatory field force & Provincial Drug Control departments have been directed to instantly conduct market surveys for detection and removal of these products from the market.
🧑⚕️Direction for the Pharmacists & Chemists regarding DRAP recall:
All pharmacists and chemists working at distributors and pharmacies are directed to immediately check their stocks and stop supplying the products containing hydroxyprogesterone caproate. The remaining stocks should be separated, and the data 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 via VigiMobile App, or by Email at gsms@dra.gov.pk.
🙍♂️Directions to the consumers regarding DRAP recall:
All the consumers of these products are advised to stop using above-mentioned products and contact their health care provider or doctors, in case of any adverse effect in relation to these products.
Reference:
Drug Regulatory Authority of Pakistan. (2025, June 23). Recall alert: Recall of products containing hydroxyprogesterone caproate [Recall alert]. https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/recall-alert-recall-of-products-containing-hydroxyprogesterone-caproate/
