Class 4 MHRA drug alert – Levofloxacin 500mg tablets (Teva UK Limited)

Class 4 MHRA drug alert – Levofloxacin 500mg tablets (Teva UK Limited)

April 16, 2020

Class 4 MHRA drug alert – Levofloxacin 500mg tablets (Teva UK Limited)

Drug alert number: EL (20)A/21

Date issued: 16 April 2020

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 pharmacy level caution in use for:

Levofloxacin 500mg tablets (Teva UK Limited)

TEVA UK Limited has informed MHRA that the Product Code/GTIN (PC) number found on the above batches is incorrect. The GTIN number that should have been allocated for this batch of tablets is 05017007064459, however, 05017007064435 was applied in error which scans the batches as Levofloxacin 250mg Tablets. The product packed, the blister primary data, PIL primary data and carton primary data were confirmed as correct for a Levofloxacin 500mg Tablet batch.

Batch Number Expiry Date Pack Size First Distributed
105362 April 2021 10 Sept 2019

Advice for healthcare professionals

  • The GTIN barcode should not be used for any dispensing activities for the affected batch 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.

For customer services queries, please contact general.enquiries@tevauk.com or telephone the Freephone number 0800 590 502

For medical enquiries and/or suspected adverse reaction reporting, please contact medinfo@tevauk.com or telephone 020 7540 7117

For product quality queries, please contact general.enquiries@tevauk.com or telephone the Freephone number 0800 590 502

PL number: PL 00289/1047

To view the alert please visit the GOV.uk website.



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