Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Reported: April 5, 2017 Initiated: March 20, 2017 #D-0621-2017
Product Description
Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Reason for Recall
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 452,269 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 452,269 bottles.
Why was this product recalled? ▼
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 5, 2017. Severity: Moderate. Recall number: D-0621-2017.
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