Class 2 Medicines Recall: Ferring Pharmaceuticals Limited, GONAPEPTYL Depot 3.75mg, Powder and solvent for suspension for injection, EL(23)A/12

Source: MHRA /Gov.uk 23.3.23

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.

MDR number

MDR 065-03/23

Company name

Ferring Pharmaceuticals Limited

Product name

GONAPEPTYL Depot 3.75mg, Powder and solvent for suspension for injection, PL 03194/0085

SNOMED Code

5615111000001102

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.

Advice for patients

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. This product is administered by healthcare professionals directly. If you have concerns about a medicine you may be using, please contact your healthcare professional.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Suspected adverse reactions may also be reported by emailing medical.uk@ferring.com or calling 0800 111 4126.

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

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Telephone +44 (0)20 3080 6574

DMRC@mhra.gov.uk

Appendix 1: Images of the content of GONAPEPTYL Depot 3.75mg

Image of the 30mm needle packaged within each pack of GONAPEPTYL Depot 3.75mg

Close-up image of a small breach observed at the peel-away needle wrapping for the 30mm needle

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Class 2 Medicines Recall: Ferring Pharmaceuticals Limited, GONAPEPTYL Depot 3.75mg, Powder and solvent for suspension for injection, EL(23)A/12

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