Class 4 Medicines Defect Information: Levofloxacin 500mg Tablets, PL 00289/1047 EL (20)A/21

TEVA UK Limited has informed us that the Product Code/GTIN (PC) number found on the below batches is incorrect.

MDR Number

MDR 187-02/20

Company name

TEVA UK Limited

Product description

  • Batch number: 105362
    • Expiry date: April 2021
    • Pack size: 10
    • First distributed: Sept 2019

Brief description of the problem

TEVA UK Limited has informed us 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.

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. This batch is not subject to a recall.

Advice for healthcare professional

  • 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.

Advice for wholesalers

  • 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.

Contact details for further information

Customer services queries

Email: general.enquiries@tevauk.com

Tel: Freephone 0800 590 502

Medical enquiries and/or suspected adverse reaction reporting:

Email: medinfo@tevauk.com

Tel: 020 7540 7117

Product quality queries:

Email: general.enquiries@tevauk.com

Tel: Freephone 0800 590 502

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

Download the attachment

Class 4 Medicines Defect Information: Levofloxacin 500mg Tablets PL 00289/1047 EL (20)A/21

Published 16 April 2020