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
Reported: January 17, 2018 Initiated: September 27, 2017 #D-0212-2018
Product Description
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
Reason for Recall
Microbial Contamination of Non-Sterile Products
Details
- Recalling Firm
- Pfizer Manufacturing Deutschland GmbH
- Units Affected
- a)7387263 tablets; b)5877188 tablets; c)11755825 tablets; d) 5872816 tablets
- Distribution
- 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.
- Location
- Freiburg im Breisgau, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Pfizer Manufacturing Deutschland GmbH. Units affected: a)7387263 tablets; b)5877188 tablets; c)11755825 tablets; d) 5872816 tablets.
Why was this product recalled? ▼
Microbial Contamination of Non-Sterile Products
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 17, 2018. Severity: Moderate. Recall number: D-0212-2018.
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