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Jacobus Pharmaceutical recalls Ruzurgi tablets

The product is contaminated with yeast, mold, and aerobic bacteria

Ruzurgi product label
Photo source: FDA
Jacobus Pharmaceutical Company is recalling three lots of Ruzurgi (amifampridine) 10-mg tablets.

Laboratory tests found that the product is contaminated with yeast, mold, and aerobic bacteria that may cause serious and life-threatening infections.

The use of the defective product in patients with underlying immunosuppressive conditions such as Lambert Eaton Syndrome (LEMS) increases the concern for serious infections.

The recalled product, which is used as a treatment for Lambert Eaton Syndrome (LEMS) in patients ages 6 to less than 17, is packaged in 100 count bottles (NDC: 49938-110-01) with the following control numbers and expiration dates:

  • Control Number 18038, Expiration 03/2023, distributed between 05/25/2021 – 08/26/2021 (Canada only).
  • Control Number 18039, Expiration 03/2023, distributed between 06/01/2021 – 08/10/2021.
  • Control Number 18079, Expiration 05/2023, distributed between 08/10/2021 – 08/30/2021

The Control Number is located to the right of the bottle’s front panel below the D2 Barcode.

What to do

Consumers who have the recalled product should should stop using and return it as follows:

  • If shipping via US Postal Service ship to: Jacobus Pharmaceutical Company, Inc., P.O. Box 5290, Princeton, NJ 08540.
  • If shipping via courier service (i.e., UPS, FedEx, etc.) ship to: Jacobus Pharmaceutical Company, Inc., IRL Building, 31 Schalks Crossing Road, Plainsboro, NJ 08356.

Consumers with questions may contact the firm at (609)799-8221 ext. 2120, Monday thru Friday, from 9:00 AM to 5:00 PM (EST).

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