Drug recall D-0619-2017
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.
Reason for recall
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Lots and codes
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
Recall details
- Recalling firm
- Mylan Pharmaceuticals Inc., Morgantown, WV
- Quantity
- 299,112 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.