CLASS II Drug recall · Reported 17 Jan 2018 · FDA Enforcement Report
For Export Only Atorvastatin calcium Film-Coated Tablets a) recalled
Pfizer Manufacturing Deutschl is recalling For Export Only Atorvastatin calcium Film-Coated Tablets a) 80 mg Smt Tabs Bulk, b) 40 mg. The recall was initiated on 27 Sep 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0212-2018
- FDA event ID
- 78682
- Recalling firm
- Pfizer Manufacturing Deutschl, Freiburg im Breisgau, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Sep 2017
- FDA classified
- 8 Jan 2018
- Reported
- 17 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Cholesterol Medication
Timeline
| 27 Sep 2017 | Recall initiated by company | |
| 8 Jan 2018 | Classified by FDA | +103 days |
| 17 Jan 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Germany; products were packaged at the Pfizer Manufacturing Deutshland Gmbh location and then distributed to other countries. No product distributed in the United States or its territories.
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products
Which lots are affected?
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
Where was it sold?
Germany; products were packaged at the Pfizer Manufacturing Deutshland Gmbh location and then distributed to other countries. No product distributed in the United States or its territories.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.