Home / Recalls / Mylan Pharmaceuticals Inc. / D-0049-2021

D-0049-2021 Class III Terminated

Recalled by Mylan Pharmaceuticals Inc. — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
October 28, 2020
Initiation Date
October 2, 2020
Termination Date
January 24, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,695 bottles

Product Description

Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Reason for Recall

Out-of-specification organic impurity results obtained during routine stability testing.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: a) 8095666, Exp. Date July 2021 b) 3104664, Exp. Date July 2021

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  • D-0774-2022 Class II — Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufact (April 7, 2022)
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  • D-0452-2022 Class II — Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topica (January 21, 2022)
  • D-0462-2022 Class I — Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen ( (January 5, 2022)
  • D-1057-2020 Class III — Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals I (March 23, 2020)
  • D-1031-2020 Class II — Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceu (March 9, 2020)