Class 2 medicine recall High risk 27 November 2017

Lipitor (Atorvastatin) 80mg film-coated tablets / Atorvastatin 80mg film-coated tablets, Almus livery

Yes – this has been recalled
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. (EL (17) A/12)
What to do
Check the batch number on your pack against the list below. Do not stop taking a prescribed medicine without talking to your pharmacist, GP or prescriber first – they can check your supply and swap it if needed.
Source: Medicines and Healthcare products Regulatory Agency (MHRA) Official notice ↗

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

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Class 2 Medicines Recall: Lipitor (Atorvastatin) 80mg film-coated tablets / Atorvastatin 80mg film-coated tablets, Almus livery

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.

Updated 27 November 2017. This page summarises an official notice. Details can change – always follow the official notice.

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