Drug product
Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20
D-0622-2017
Product summary
- Event
- Event 76802
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,527 cartons
- Official record key
drug-enforcement:D-0622-2017
Official wording
Reason: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Code information: Lot #: 3084288, Exp. 07/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial Contamination