D-1213-2015 Class II Terminated
FDA drug recall D-1213-2015 was initiated by Apotex Inc. on May 29, 2015 and is designated Class II. Reason for recall: Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification. The recall status is terminated (terminated Mar 3, 2017). Affected quantity: 23,178 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 15, 2015
- Initiation Date
- May 29, 2015
- Termination Date
- Mar 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,178 bottles
Product description
Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3162-9
Reason for recall
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Distribution pattern
Nationwide, Hawaii and Puerto Rico
Code information
Lot #: KT3819, Exp 11/2015; Lot #: KT3821, Exp 11/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1213-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026