# FDA recall D-0389-2022

> **Medique Products** · Class II · drug recall initiated 2021-12-06.

## Product

Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577 90316 6

## Reason for recall

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0389-2022
- **Recalling firm:** Medique Products
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-12-06
- **Report date:** 2022-01-26
- **Termination date:** 2023-06-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fort Myers, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0389-2022

## Citation

> AI Analytics. FDA recall D-0389-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0389-2022. Source: US FDA. Licensed CC0.

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