Recalls / Class II
Class IID-0621-2017
Product
Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), 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) 3073782, 3073783, Exp 02/18; 3074915, 3074916, 3074917, Exp 03/18; 3074918, 3075572, Exp 04/18; 3075573, 3075574, Exp 05/18; 2007226, 3075894, Exp 06/18; 2007344, 2007345, 2007346, Exp 08/18; 2007451, 2007452, 2007453, 2007454, Exp 09/18; b) 3070840, Exp 10/17; 3073781, 3074911, Exp 02/18; 3074912, 3074913, 3074914, Exp 03/18; 3075570, 3075571, Exp 04/18; 3075892, Exp 05/18; 3075893, Exp 06/18; 2007341, 2007342, 2007343, 2007347, Exp 08/18; 2007456, 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
- 452,269 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-0621-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.