Drug recall D-0620-2017
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.
Reason for recall
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Lots and codes
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
Recall details
- Recalling firm
- Mylan Pharmaceuticals Inc., Morgantown, WV
- Quantity
- 444,201 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 20, 2017
- Terminated
- January 26, 2018
Related products
- Atorvastatin Calcium – drug information
- NDC 0378-3952 Atorvastatin Calcium · Atorvastatin Calcium Trihydrate 40 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-3950 Atorvastatin Calcium · Atorvastatin Calcium Trihydrate 10 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-3951 Atorvastatin Calcium · Atorvastatin Calcium Trihydrate 20 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-3953 Atorvastatin Calcium · Atorvastatin Calcium Trihydrate 80 mg/1 · Mylan Pharmaceuticals Inc.