FDA Recall D-0008-2022
Jacobus Pharmaceutical Company Inc. · Plainsboro, NJ
Class I — life-threatening Terminated 162 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0008-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only.
- Recall initiated
- 2021-09-09
- Classified by FDA Center
- 2021-10-08
- FDA published
- 2021-10-06
- Terminated
- 2022-02-18
- Recalling firm
- Jacobus Pharmaceutical Company Inc.
- Firm location
- Plainsboro, NJ