# FDA recall D-0665-2021

> **LNK International, Inc.** · Class III · drug recall initiated 2021-07-07.

## Product

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 46122-649-71

## 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'

## Distribution

Distributed in PA

## Key facts

- **Recall number:** D-0665-2021
- **Recalling firm:** LNK International, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-07-07
- **Report date:** 2021-07-28
- **Termination date:** 2023-05-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hauppauge, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0665-2021

## Citation

> AI Analytics. FDA recall D-0665-2021. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0665-2021. Source: US FDA. Licensed CC0.

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