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
Reported: July 15, 2015 Initiated: May 29, 2015 #D-1215-2015
Product Description
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
Reason for Recall
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Details
- Recalling Firm
- Apotex Inc.
- Units Affected
- 4,584 bottles
- Distribution
- Nationwide, Hawaii and Puerto Rico
- Location
- Toronto, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Apotex Inc.. Units affected: 4,584 bottles.
Why was this product recalled? ▼
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 15, 2015. Severity: Moderate. Recall number: D-1215-2015.
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