Class 4 Medicines Defect Information: Zamadol SR 50 mg prolonged-release hard capsules (Mylan UK Healthcare Ltd)

Class 4 Medicines Defect Information: Zamadol SR 50 mg prolonged-release hard capsules (Mylan UK Healthcare Ltd)

March 25, 2020

Class 4 Medicines Defect Information – Zamadol SR 50 mg prolonged-release hard capsules (Mylan UK Healthcare Ltd)

Drug alert number: (EL(20)A/18)

Date issued: 25 March 2020

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for:

Zamadol SR 50 mg prolonged-release hard capsules (Mylan UK Healthcare Ltd) PL 46302/0149

Mylan UK Healthcare Ltd has informed the MHRA that the GTIN barcode applied on the batches listed belowis incorrect. The GTIN number that should have been allocated for these batches of capsules is 05060035240173, however, 05060035241477 was applied in error which scans the batches as Zamadol Melt Tablet 50mg. All other information on the carton and label, including the EAN barcode is correct for the above batches of Zamadol SR 50 mg prolonged-release hard capsules.

There may be residual risk in cases where wholesalers and pharmacies use automated inventory system to dispense the affected batches within the pharmacy or wholesale facility. Due to concerns with continuity of supply these batches are not being recalled at this time.

Batch Number Expiry Date Pack Size First Distributed
8L221D 09/2021 60 30/05/2019
9B225A 01/2022 60 30/09/2019

Advice for healthcare professional

  • The GTIN barcode should not be used for any dispensing activities for the affected batches listed above. Please bring this notice to the attention of all relevant staff within your facility.
  • If you have supplied units from this batch to any other pharmacy or clinic, please forward a copy of this Alert to them.

Further Information

For more information or medical information enquiries please contact Mylan UK Healthcare Ltd. Medical Information Department on +44(0) 1707 853000 or via email on Info.uk@mylan.co.uk

View the full alert here

 



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