# FDA recall D-1004-2020

> **Precision Dose Inc.** · Class II · drug recall initiated 2019-11-13.

## Product

Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080

## Reason for recall

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-1004-2020
- **Recalling firm:** Precision Dose Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-11-13
- **Report date:** 2020-03-18
- **Termination date:** 2022-09-17

- **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-1004-2020

## Citation

> AI Analytics. FDA recall D-1004-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1004-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*