Could cause temporary or reversible harm; serious harm is unlikely.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
| Brand name | LISINOPRIL AND HYDROCHLOROTHIAZIDE |
| Generic name | LISINOPRIL AND HYDROCHLOROTHIAZIDE |
| Active ingredient(s) | HYDROCHLOROTHIAZIDE, LISINOPRIL |
| Distributed by / for | Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; |
| NDC | 68180-518-01 |
| Full product label | Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, India. NDC: 68180-518-01 |
| Recalling firm | CARDINAL HEALTHCARE |
| Distribution | Nationwide USA |
| Quantity | 2 units |
| Recall initiated | 2022-01-26 |
| Report date | 2024-01-03 |
| Recall completed | 2024-09-29 |
| Recall number | D-0188-2024 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Dublin OH United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗