Drug recall
NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd…
FDA recall event 63264 · Class II · Glenmark Generics Inc., USA
Key facts
| Event ID | 63264 |
|---|---|
| Recall numbers | D-1701-2012 |
| Recalling firm | Glenmark Generics Inc., USA |
| Product type | Drugs |
| Products | NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg. |
| Initiation date | Jul 6, 2012 |
| Report date | Oct 3, 2012 |
| Termination date | Aug 13, 2015 |
| City | Mahwah |
| State | NJ |
| Country | United States |
| FEI number | 3005658103 |
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: