D-0243-2015 Class III Terminated
FDA drug recall D-0243-2015 was initiated by Apotex Inc. on Oct 16, 2014 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities. The recall status is terminated (terminated Sep 30, 2016). Affected quantity: 11,062 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 12, 2014
- Initiation Date
- Oct 16, 2014
- Termination Date
- Sep 30, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,062 bottles
Product description
Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.
Distribution pattern
Nationwide.
Code information
Lot #: a) KR3943; Exp. 11/15 Lot #: b) KT6058, KT6060; Exp. Date 11/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0243-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026