D-0049-2021 Class III Terminated
FDA drug recall D-0049-2021 was initiated by Mylan Pharmaceuticals Inc. on Oct 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 Jan 24, 2022). Affected quantity: 10,695 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Oct 28, 2020
- Initiation Date
- Oct 2, 2020
- Termination Date
- Jan 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0049-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026