Jacobus Worldwide Recall of Ruzurgi® (amifampridine) 10 mg Tablets Due to Mold, Yeast, and Bacterial Contamination
According to the FDA and Jacobus Pharmaceutical Company Incorporated, three lots of Ruzurgi® (amifampridine) 10 mg tablets have been recalled due to mold, yeast, and aerobic bacteria contamination. The recall applies to the consumer/patient level.
Medications that are heavily contaminated with mold, aerobic bacteria, or yeast can cause “serious and life-threatening infections.” A patient with underlying immunosuppressive medical conditions such as Lambert Eaton Syndrome (LEMS) raises the risk of serious infection.
Ruzurgi® (amifampridine) 10 mg tablets are used to treat patients ages 6 to 17 with LEMS. The packaged in 100 count bottles (NDC: 49938-110-01). The affected Ruzurgi® (amifampridine) tablets lots are packaged in 100-count bottles, have an NDC of 49938-110-01, and include one of the following expiration dates and control numbers:
- Expiration 03/2023, Control Number 18038,
- Expiration 03/2023, Control Number 18039
- Expiration 05/2023, Control Number 18079
- Control Number 18038 was distributed between 05/25/2021 – 08/26/2021 (Canada only)
- Control Number 18039 was distributed between 06/01/2021 – 08/10/2021
- Control Number 18079 was distributed between 08/10/2021 – 08/30/2021
The Control Number can be found below the D2 Barcode and at the right of the bottle’s front panel.
Ruzurgi® (amifampridine) is distributed worldwide to specialty physicians and pharmacies. Consumers that have one of the affected Ruzurgi® (amifampridine) products should immediately stop using the product and return the product for a replacement.
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