Ruzurgi recall: Sterility Concern
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.
Why was Ruzurgi recalled?
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 18038, 18039, Exp 03/2023; 18079, Exp 05/2023
- 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.
- Recalling firm
- Jacobus Pharmaceutical Company Inc.
- Quantity
- 2,324 bottles
- Distribution
- Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only.
- Recall date
- October 6, 2021
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)