Drug recall
Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India…
FDA recall event 71946 · Class II · Wockhardt Usa Inc.
Key facts
| Event ID | 71946 |
|---|---|
| Recall numbers | D-1346-2015, D-1347-2015 |
| Recalling firm | Wockhardt Usa Inc. |
| Product type | Drugs |
| Products | Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3…, Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints. |
| Initiation date | Jul 29, 2015 |
| Report date | Aug 26, 2015 |
| Termination date | Apr 12, 2017 |
| City | Parsippany |
| State | NJ |
| Country | United States |
| FEI number | 3003060524 |
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: