Drug recall
Our Family Ibuprofen CAPLETS, IBUPROFEN TABLETS USP (NSAID) 200 mg, 24 CAPLETS, 200 mg EACH, NDC 70253-292-08…
FDA recall event 54461 · Class III · LNK International, Inc.
Key facts
| Event ID | 54461 |
|---|---|
| Recall numbers | D-353-2010 |
| Recalling firm | LNK International, Inc. |
| Product type | Drugs |
| Products | Our Family Ibuprofen CAPLETS, IBUPROFEN TABLETS USP (NSAID) 200 mg, 24 CAPLETS, 200 mg EACH, NDC 70253-292-08, OTC -- DISTRIBUTED BY: NASH FINCH COMPANY 7600 France Ave. S, MINNEAPOLIS, MN 55435 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Mislabeling: the directions on the outer box are wrong and lack the word "not", thereby incorrectly reading "Do exceed 6 caplets in 24 hours unless directed by a doctor". |
| Initiation date | Dec 31, 2009 |
| Termination date | Aug 2, 2010 |
| City | Hauppauge |
| State | NY |
| Country | United States |
| FEI number | 2432212 |
At a glance
- 1–9 Products in this recall
- 10–99 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