Jacobus Pharmaceutical Company Inc.: Drug Recall
Recall #D-0008-2022 · 09/09/2021
Class I: Dangerous
Recall Details
- Recall Number
- D-0008-2022
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- Jacobus Pharmaceutical Company Inc.
- Status
- Terminated
- Date Initiated
- 09/09/2021
- Location
- Plainsboro, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,324 bottles
Reason for Recall
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
Product Description
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.
Distribution Pattern
Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.