Home / Recalls / Mylan Pharmaceuticals Inc. / D-0619-2017

D-0619-2017 Class II Terminated

Recalled by Mylan Pharmaceuticals Inc. — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
April 5, 2017
Initiation Date
March 20, 2017
Termination Date
January 26, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
299,112 bottles

Product Description

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

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

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  • D-0049-2021 Class III — Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packag (October 2, 2020)
  • D-1057-2020 Class III — Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals I (March 23, 2020)