Class 2 Medicines Recall: Lipitor (Atorvastatin) 80mg film-coated tablets / Atorvastatin 80mg film-coated tablets, Almus livery
Pfizer is recalling the above batches as a precaution due to an out of specification result for microbiological testing during routine stability studies on a batch of the product which was not released to the market. (EL (17) A/12)
Product information
MDR number
MDR 96-11/17
Company name
Pfizer Ireland Pharmaceuticals
Product description
Lipitor (Atorvastatin) 80mg film-coated tablets (PL 39933/0004) Atorvastatin 80mg film-coated tablets, Almus livery (PL 39933/0012)
Batch number/expiry
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| T43157 (Almus) | 31 Jan 2020 | 1 x 28 | 10 Sep 2017 |
| T43166 (Lipitor) | 31 Jan 2020 | 1 x 28 | 05 Sep 2017 |
| T43170 (Lipitor) | 31 Jan 2020 | 1 x 28 | 30 Aug 2017 |
Brief description of the problem
Pfizer is recalling the above batches as a precaution due to an out of specification result for microbiological testing during routine stability studies on a batch of the product which was not released to the market. The above batches were identified as being potentially affected by the same issue during the root cause investigation, although no out of specification microbiological results have been reported for these batches.
Advice for healthcare professionals & wholesalers
Remaining stock of these batches should be quarantined and returned to the original supplier for credit.
Medical information enquiries
For Medical information enquiries, please contact Pfizer Medical Information on 01304 616161
Stock enquiries
For stock enquiries, please contact your local branch of Alliance Healthcare
Download document
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, community pharmacists and dispensing GPs for action; and to General Practitioners for information.