Why it was recalled
Failed Dissolution Specifications
Product description
Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottle (NDC 0603-4214-28), Rx Only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811
Lot numbers, UPCs & expiration codes
Lot # a) C0570215B; Exp 02/17 b) C0570215A; Exp 02/17
Where it was sold
Nationwide 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-1406-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 29, 2015
- FDA report date
- Sep 9, 2015
- Quantity
- 8,705 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
Original FDA data
Every field from FDA enforcement report D-1406-2015, exactly as published.
Show all FDA fields
- City
- Huntsville
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 71863
- Address
- 130 Vintage Dr Ne
- Code information
- Lot # a) C0570215B; Exp 02/17 b) C0570215A; Exp 02/17
- Postal code
- 35811-8216
- Report date
- Sep 9, 2015
- Product type
- Drugs
- Recall number
- D-1406-2015
- Classification
- Class II
- Recalling firm
- Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
- Product quantity
- 8,705 bottles
- Termination date
- Mar 29, 2016
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottle (NDC 0603-4214-28), Rx Only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jul 29, 2015
- Initial firm notification
- Letter
- Center classification date
- Sep 1, 2015