Recalls / Class II
Class IID-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.
- Brand name
- Atorvastatin Calcium
- Generic name
- Atorvastatin Calcium
- Active ingredient
- Atorvastatin Calcium Trihydrate
- Route
- Oral
- NDCs
- 0378-3950, 0378-3951, 0378-3952, 0378-3953
- FDA application
- ANDA091226
- Affected lot / code info
- 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
Why it was recalled
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 1,233,107 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2017-03-20
- FDA classified
- 2017-03-28
- Posted by FDA
- 2017-04-05
- Terminated
- 2018-01-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0618-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.