# FDA recall D-0057-2018

> **Precision Dose Inc.** · Class III · drug recall initiated 2017-09-25.

## Product

Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL  61080.

## Reason for recall

Subpotent Drug: low out of specification results.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0057-2018
- **Recalling firm:** Precision Dose Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-09-25
- **Report date:** 2017-11-08
- **Termination date:** 2018-04-23

- **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-0057-2018

## Citation

> AI Analytics. FDA recall D-0057-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0057-2018. Source: US FDA. Licensed CC0.

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