Why it was recalled
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
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
Lot numbers, UPCs & expiration codes
Lot #: KP4529, Exp 10/2015
Where it was sold
Nationwide, Hawaii and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1215-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 29, 2015
- FDA report date
- Jul 15, 2015
- Quantity
- 4,584 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D-1215-2015, exactly as published.
Show all FDA fields
- City
- Toronto
- Status
- Terminated
- Country
- Canada
- Event ID
- 71418
- Address
- 150 Signet Drive
- Code information
- Lot #: KP4529, Exp 10/2015
- Report date
- Jul 15, 2015
- Product type
- Drugs
- Recall number
- D-1215-2015
- Classification
- Class II
- Recalling firm
- Apotex Inc.
- Product quantity
- 4,584 bottles
- Termination date
- Mar 3, 2017
- Reason for recall
- Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide, Hawaii and Puerto Rico
- Recall initiation date
- May 29, 2015
- Initial firm notification
- Letter
- Center classification date
- Jul 7, 2015