Drug recall
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each…
FDA recall event 88244 · Class III · LNK International, Inc.
Key facts
| Event ID | 88244 |
|---|---|
| Recall numbers | D-0665-2021 |
| Recalling firm | LNK International, Inc. |
| Product type | Drugs |
| Products | Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet' |
| Initiation date | Jul 7, 2021 |
| Report date | Jul 28, 2021 |
| Termination date | May 4, 2023 |
| 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 · Source date: