FDAFDA · Food and drugs·Recall number D-0621-2017
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.
Published April 5, 2017 · Recall initiated: March 20, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- Nationwide in the USA and Puerto Rico
- UPC
- 0303783953779
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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