Drug 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.
D-0008-2022
Product summary
- Event
- Event 88647
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2,324 bottles
- Official record key
drug-enforcement:D-0008-2022
Official wording
Reason: Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
Code information: Lot #: 18038, 18039, Exp 03/2023; 18079, Exp 05/2023
Distribution pattern: Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only.
Derived failure modes
-
Microbial contamination
Microbial contamination