Could cause temporary or reversible harm; serious harm is unlikely.
Failed Impurities/Degradation Specifications: Out of Specification results for Individual Other Unknown Related Compounds were obtained at the 48 month time-point.
| Distributed by / for | Blu Pharmaceuticals, Franklin, KY 42134; |
| NDC | 0143-1265-01 |
| Full product label | Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10), Manufactured by: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724; and c) 1000-count bottles (NDC 24658-240-10), Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724. |
| Recalling firm | West-Ward Pharmaceutical Corp. |
| Distribution | Nationwide |
| Quantity | 51,704 bottles |
| Recall initiated | 2013-07-30 |
| Report date | 2013-08-14 |
| Recall completed | 2014-06-03 |
| Recall number | D-853-2013 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Eatontown NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗