D-0049-2021 Class III Terminated
FDA drug recall D-0049-2021 was initiated by Mylan Pharmaceuticals Inc. on October 2, 2020 and is designated Class III. Reason for recall: Out-of-specification organic impurity results obtained during routine stability testing. The recall status is terminated (terminated January 24, 2022). Affected quantity: 10,695 bottles.
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