# FDA recall D-0008-2022

> **Jacobus Pharmaceutical Company Inc.** · Class I · drug recall initiated 2021-09-09.

## Product

Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. Box 5290, Princeton, New Jersey  08540, NDC 49938-110-01.

## Reason for recall

Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.

## Distribution

Product was distributed within the USA and Canada.  Control # 18038, was distributed to Canada only.

## Key facts

- **Recall number:** D-0008-2022
- **Recalling firm:** Jacobus Pharmaceutical Company Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-09-09
- **Report date:** 2021-10-06
- **Termination date:** 2022-02-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plainsboro, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0008-2022

## Citation

> AI Analytics. FDA recall D-0008-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0008-2022. Source: US FDA. Licensed CC0.

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