Drug product
Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
D-0620-2017
Product summary
- Event
- Event 76750
- Status
- Terminated
- Classification
- Class II
- Quantity
- 444,201 bottles
- Official record key
drug-enforcement:D-0620-2017
Official wording
Reason: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Code information: Lot #: a) 3073779, 3073780, Exp 02/18; 3074910, Exp 03/18; 3075568, Exp 04/18; 3075889, 3075890, Exp 06/18; 2007339, 2007340, Exp 08/18; 3079881, 3079882, Exp 10/18; b) 3070839, Exp 10/17; 3073778, 3073779, Exp 02/18; 3075566, 3075567, Exp 04/18; 3075890, 2007225, Exp 06/18; 2007340, Exp 08/18; 3079880, 3079881, Exp 10/18
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Microbial contamination
Microbial Contamination