Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical C
Summary
The FDA issued a Class I for Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, M by Jacobus Pharmaceutical Company Inc.. Reason: Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts..
Details
Source
Drug Recall
External ID
D-0008-2022
Action Date
2021-10-06
Status
Terminated
Category
drug
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.
Lot/Code Info: Lot #: 18038, 18039, Exp 03/2023; 18079, Exp 05/2023
Quantity Affected: 2,324 bottles
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
Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-09
Company
Plainsboro, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 107 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Jacobus Pharmaceutical Company Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Jacobus Pharmaceutical Company Inc. have FDA actions?
This is the only FDA action we have on record for Jacobus Pharmaceutical Company Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0008-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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