# FDA recall D-0095-2022

> **Precision Dose Inc.** · Class II · drug recall initiated 2021-11-01.

## Product

Acetaminophen Oral Suspension, 325 mg/10.15 mL,  packaged in 10.15 mL per cup (NDC Individual cup: 68094-330-59), in a) 30-count case (NDC 30-count case: 68094-330-62), and b) 100-count case (NDC 100-count case:  68094-330-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.

## Reason for recall

cGMP Deviations: Product manufactured with contaminated raw ingredient.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0095-2022
- **Recalling firm:** Precision Dose Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-11-01
- **Report date:** 2021-11-17
- **Termination date:** 2024-07-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Beloit, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0095-2022

## Citation

> AI Analytics. FDA recall D-0095-2022. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/D-0095-2022. Source: US FDA. Licensed CC0.

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