Drug product
Enalapril maleate and hydrochlorothiazide tablets USP, 10/25 mg, 100-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 60505-0209-1
D-1215-2015
Product summary
- Firm
- Apotex Inc.
- Event
- Event 71418
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,584 bottles
- Official record key
drug-enforcement:D-1215-2015
Official wording
Reason: Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Code information: Lot #: KP4529, Exp 10/2015
Distribution pattern: Nationwide, Hawaii and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Content Uniformity Specifications