D-0008-2022 Class I Terminated
FDA drug recall D-0008-2022 was initiated by Jacobus Pharmaceutical Company Inc. on September 9, 2021 and is designated Class I. Reason for recall: Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts. The recall status is terminated (terminated February 18, 2022). Affected quantity: 2,324 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 6, 2021
- Initiation Date
- September 9, 2021
- Termination Date
- February 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,324 bottles
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.
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 Pattern
Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only.
Code Information
Lot #: 18038, 18039, Exp 03/2023; 18079, Exp 05/2023