Class 2 Medicines Recall: Nitrofurantoin CNX Therapeutics 100 mg Prolonged-Release capsules, EL(25)A/05

CNX Therapeutics is recalling the batches listed in this notification as a precautionary measure due to a small number of packs that contain an additional tablet of Nitrofurantoin. The registered product is a capsule containing powder and two yellow tablets.

DMRC Number: DMRC-34425982

Company name: CNX Therapeutics Limited

Product description: Nitrofurantoin CNX Therapeutics 100 mg Prolonged-Release capsules

PL: 19635/0006 SNOMED code: 44125511000001105

Details of the affected batches: 

Brief description of problem:

CNX Therapeutics is recalling the above batches as a precautionary measure due to a small number of packs that contain an additional tablet of Nitrofurantoin. The registered product is a capsule containing powder and two yellow tablets. A small percentage of blister pockets have been found to contain an additional yellow tablet alongside the capsule, these are from the manufacturing process and not from broken capsules. See full recall for a photo of the blister with an extra tablet enclosed.

Advice to Healthcare Professionals:

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

Should a patient present a pack containing an extra tablet, the tablet may be removed and the patient assured that the capsule is safe to take stating the extra tablet did not come from the capsule.

Advice to Patients: 

If you find a pack containing an additional tablet, please take the medication to the dispensing pharmacy you obtained the medicine from. Patients may continue to take capsules from non-impacted packs as prescribed by your healthcare professional.

A small percentage of blister pockets have been found to contain an additional yellow tablet alongside the capsule, these are from the manufacturing process and not from broken capsules.

Patients that have taken the additional tablet with the capsule have ingested a higher dose of nitrofurantoin than was intended, however, the effects are understood and this should not have caused harm.

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.

Company contacts for further information:

For medical information enquiries please contact 0207 821 2840 or medinfo@cnx-therapeutics.com

For stock control enquiries please contact 0207 821 2840 or supplychain@cnx-therapeutics.com

To access the full recall: Class 2 Medicines Recall: Nitrofurantoin CNX Therapeutics 100 mg Prolonged-Release capsules, EL(25)A/05