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 for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217 |
| NDC | 68084-061-11 |
| Full product label | Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11); 10 blister packs per carton (NDC 68084-061-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217. |
| Recalling firm | American Health Packaging |
| Distribution | Nationwide |
| Quantity | 13,532 cartons |
| Recall initiated | 2015-06-01 |
| Report date | 2015-07-15 |
| Recall completed | 2017-02-22 |
| Recall number | D-1227-2015 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Columbus OH United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗