FDA Drug Class II — Moderate

Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20

Hazard

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

Products

Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20
Brand
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
UPC
Lot #: 3084288, Exp. 07/18

Units Affected

1,527 cartons