Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial Contamination of Non-Sterile Products
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What 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
Drug: Atorvastatin Category: Cholesterol Medication
- Recalling firm
- Pfizer Manufacturing Deutschland GmbH
- Origin
- N/A, Germany
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0212-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Atorvastatin recalls
See all
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 40 mg
Failed dissolution specifications: lower than specifications
Other microbial contamination recalls from 2017
All microbial contamination recalls
Class II · Moderate risk
Earth's Care Eczema Lotion
Microbial Contamination of Non-Sterile Products.
Class I · High risk
Linezolid Injection 600 mg/300 mL
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Class II · Moderate risk
Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant
Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
Class II · Moderate risk
Maximum Strength Zephrex-D
Microbial Contamination of Non-Sterile Products
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