Recalls / Class II
Class IID-1406-2015
Product
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
- Affected lot / code info
- Lot # a) C0570215B; Exp 02/17 b) C0570215A; Exp 02/17
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 130 Vintage Dr Ne, N/A, Huntsville, Alabama 35811-8216
Distribution
- Quantity
- 8,705 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-07-29
- FDA classified
- 2015-09-01
- Posted by FDA
- 2015-09-09
- Terminated
- 2016-03-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1406-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.