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Drug safety update on Ranitidine 150mg Film-coated Tablets (PL 20075/0063)

Drug safety update on Ranitidine 150mg Film-coated Tablets (PL 20075/0063)

Accord Healthcare Limited, in agreement with the Medicines and Healthcare products Regulatory Agency (MHRA) would like to inform you of the following: 

Batches of Ranitidine Tablets 150mg (PL 20075/0063) on the market in the UK have been found to have the batch number and expiry date prompts printed on the carton in German as "Ch. - B" & "Verwendbar bis" instead of "LOT." & "EXP" (see Annex 1 for list of 31 batches that have been released onto UK market).

  • The batch numbers and expiry dates provided on the packaging are correct, and the prompts appear in English on the primary (blister) packs.
  • All the batches have been manufactured in accordance with Good Manufacturing Practice requirements and, with exception of the print error on the carton, comply with the terms of the Manufacturing Authorisation.
  • The print error on the carton is not anticipated to pose a risk to usability or traceability of product.
  • Patients should be reassured that this is an approved UK product at time of dispensing or in case of any queries.

Please see attached full details