Recalls / Class II
Class IID-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.
- 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) 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
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
- 444,201 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-0620-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.