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.
Reported: October 6, 2021 Initiated: September 9, 2021 #D-0008-2022
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.
Details
- Recalling Firm
- Jacobus Pharmaceutical Company Inc.
- Units Affected
- 2,324 bottles
- Distribution
- Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only.
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Jacobus Pharmaceutical Company Inc.. Units affected: 2,324 bottles.
Why was this product recalled? ▼
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 6, 2021. Severity: Critical. Recall number: D-0008-2022.
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