Mylan Pharmaceuticals Inc. recalls Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-

Recalled April 5, 2017 · FDA recall D-0618-2017 · Mylan Pharmaceuticals

Hazard

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms. · FDA Class II

Units

1,233,107 bottles

Sold at

Nationwide in the USA and Puerto Rico

Description

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

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.

Manufacturer(s)

Mylan Pharmaceuticals Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →