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
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