Drug recall D-0618-2017
Product
Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), 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) 3076141, 3076142, Exp 05/18; 2007223, Exp 06/18; 2007335, Exp 07/18; 2007336, Exp 08/18; 2007446, 3084691, Exp 09/18; 3084692, Exp 01/18; b) 3073773, Exp 01/18; 2007445, Exp 09/18; c) 3076139, 3076140, 3076143, Exp 05/18; 3076144, 3076145, Exp 06/18; 2007445, Exp 09/18; d) 3070837, Exp 10/17; 3073773, Exp 01/18; 3076139, Exp 05/18; 3073774, Exp 01/18; 2007445, Exp 09/18
Recall details
- Recalling firm
- Mylan Pharmaceuticals Inc., Morgantown, WV
- Quantity
- 1,233,107 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.