Recalls / Class II
Class IID-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.
- 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) 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
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
- 299,112 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-0619-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.