Candesartan Cilexetil and Hydrochlorothiazide Tablets recall: Impurity Out of Spec
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.
Why was Candesartan Cilexetil and Hydrochlorothiazide Tablets recalled?
Out-of-specification organic impurity results obtained during routine stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: a) 8095666, Exp. Date July 2021 b) 3104664, Exp. Date July 2021
- Product
- 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.
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Quantity
- 10,695 bottles
- Distribution
- Nationwide within the United States
- Recall date
- October 28, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)