The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0212-2018·Announced 2018-01-17

Pfizer Recalls Atorvastatin Tablets Due to Microbial Contamination

Pfizer is recalling specific export-only batches of atorvastatin calcium tablets due to microbial contamination. No product was distributed in the United States.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric for significant health risks such as microbial contamination.

Plain-English summary

Pfizer Manufacturing Deutschland GmbH is recalling specific batches of Atorvastatin calcium Film-Coated Tablets intended for export only. The recall is due to microbial contamination of these non-sterile products. The affected products include 80 mg, 40 mg, and 20 mg tablets in various bulk and packaged configurations.

The affected batches were packaged at the Pfizer Manufacturing Deutschland GmbH location in Germany and distributed to other countries. The source text explicitly states that no product was distributed in the United States or its territories. Specific batch numbers and expiration dates for the affected lots are listed in the official recall documentation.

Consumers in the United States are not affected by this recall. Individuals in other countries who possess these specific batches should follow the instructions provided by local health authorities or the manufacturer regarding the return or disposal of the medication.

The recalled product

Product
FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G EP PR, d) 20 mg SMT G EP PR KR, FOR MANUFACTURING, PROCESSING OR REPACKAGING
Manufacturer
Pfizer Manufacturing Deutschland GmbH
Category
Drug — Antihypertensive / Cholesterol
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • Bulk Product Batch # ( Packaged Lot#) a) S55350 Exp. 20 APR 2018
  • S55378 Exp. 07 MAR 2018
  • S55386 Exp. 14 MAR 2018
  • S53284 Exp.14 FEB 2018
  • S53283 Exp. 10 FEB 2018
  • b) S53287 Exp. 16 FEB 2018
  • S33417 Exp. 03 FEB 2018
  • c) S33445 Exp. 17 FEB 2018
  • S33452 Exp. 24 FEB 2018
  • d) S33397 Exp. 07 FEB 2018

Distribution

Distribution scope not specified by the agency.

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