Drug product
Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
D-0619-2017
Product summary
- Event
- Event 76750
- Status
- Terminated
- Classification
- Class II
- Quantity
- 299,112 bottles
- Official record key
drug-enforcement:D-0619-2017
Official wording
Reason: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Code information: Lot #: a) 3073776, Exp 01/18; 3073777, 3074909, Exp 02/18; 3075564, 3075565, Exp 03/18; 2007338, Exp 08/18; b) 3070838, Exp 10/17; 3073775, Exp 01/18; 3074908, 3074909, Exp 02/18; 3075564, Exp 03/18; 2007224, 3075887, Exp 06/18; 2007337, 2007338, Exp 08/18
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Microbial contamination
Microbial Contamination