Drug recall
Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by…
FDA recall event 83354 · Class II · Lupin Pharmaceuticals Inc.
Key facts
| Event ID | 83354 |
|---|---|
| Recall numbers | D-1720-2019 |
| Recalling firm | Lupin Pharmaceuticals Inc. |
| Product type | Drugs |
| Products | Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles. |
| Initiation date | Jul 17, 2019 |
| Report date | Aug 21, 2019 |
| Termination date | Sep 14, 2020 |
| City | Baltimore |
| State | MD |
| Country | United States |
| FEI number | 3004097115 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: