Could cause temporary or reversible harm; serious harm is unlikely.
CGMP Deviations: Firm did not adequately investigate customer complaints.
| Distributed by / for | Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA |
| NDC | 64679-928-01 |
| Full product label | Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C) 1000 Count Bottles (NDC: 64679-928-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. |
| Recalling firm | Wockhardt Usa Inc. |
| Distribution | U.S. Nationwide including Puerto Rico. |
| Quantity | A) 128,594 Bottles, B) 25,472 Bottles, and C) 62,124 Bottles. |
| Recall initiated | 2015-04-22 |
| Report date | 2015-07-29 |
| Recall completed | 2018-05-09 |
| Recall number | D-1257-2015 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Parsippany NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗