MHRA Class 2 Medicines Recall: GONAPEPTYL Depot 3.75mg powder and solvent for suspension for injection (Ferring Pharmaceuticals Limited)

Drug alert number: EL(23)A/12

Date issued: 23 March 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for: GONAPEPTYL Depot 3.75mg powder and solvent for suspension for injection (Ferring Pharmaceuticals Limited)

Active Pharmaceutical Ingredient: Triptorelin

Brief description of the problem

Ferring Pharmaceuticals Limited is recalling certain batches of GONAPEPTYL Depot 3.75mg due to a defect noticed in the seal of the needle wrapping for the CE-marked 30-millimeter (30mm) needle for subcutaneous injection that is supplied with each product pack (see first image in Appendix 1).

Slight damage was detected in some sterile needle blisters, which renders the sealing to be incomplete. A small breach was observed at the peel-away opening of the needle blister, potentially compromising the sterility of the needle. The defect appears as a slight separation between the plastic and paper portions of the needle packaging (see second image in Appendix 1). There is no quality issue with the drug product.

Advice for healthcare professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Full drug alert can be viewed here.

Further Information

For all medical enquiries, please contact medical information: medical.uk@ferring.com.

For supply queries, please contact customer services: customer.services@ferring.com