Class 2 Medicines Recall: Paracetamol 500mg Tablets, 1 x 1000 PL 04077/0001 (MDR 13-04/19)
M & A Pharmachem is recalling the above batches because a small number of pots from each batch have been found to contain discoloured tablets due to fungal contamination.
MDR Number
MDR 13-04/19
Company name
M & A Pharmachem Limited
Product description
Paracetamol 500mg Tablets, 1 x 1000
PL 04077/0001
Batch number | Expiry Date | Pack size | First distributed |
---|---|---|---|
0110 | June 2023 | 1 x 1000 | 6 September 2018 |
0174 | October 2023 | 1 x 1000 | 14 March 2019 |
Brief description of the problem
M & A Pharmachem is recalling the above batches because a small number of pots from each batch have been found to contain discoloured tablets due to fungal contamination.
The fungi have been identified as Penicillium citrinium and Penicillium brevicompactum. It is unlikely that any affected tablets will have got to patient level as the discolouration is noticeable on opening affected packs.
Advice for wholesalers and healthcare professionals
Stop supplying the batches listed above immediately.
Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Contact details for further information
For stock enquiries, please contact Pauline Caddick, Responsible Person:
For medical Information enquiries, please contact Cristina Parau, Pharmacovigilance Manager:
Additional information
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 relevant clinics, general practitioners and community pharmacists.
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