Plainsboro, NJ, United States
Jacobus Pharmaceutical Company Inc. recalls
1 recall recorded since 2018, most recently on 9 September 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I Drugs
- Recall started
- 9 September 2021
- Terminated
- 18 February 2022
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0008-2022
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.