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)

Batch number Expiry date Pack size First distributed
T16656K Mar 2024 1 19 May 2022
U11271E Jun 2024 1 15 Jun 2022
U11271F Jul 2024 1 14 Jun 2022
U11386G Nov 2024 1 25 Aug 2022
U11570E Dec 2024 1 09 Nov 2022
U11571E Dec 2024 1 03 Oct 2022
U15102C May 2025 1 30 Dec 2022
U15102K May 2025 1 13 Feb 2023
U15102L May 2025 1 08 Feb 2023

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