There's a worldwide recall of a medication for a rare autoimmune disorder., Lambert Eaton Syndrome. The medicine can be contaminated with bacteria, molds and yeasts. People with this syndrome are already immunosuppressive so this can be serious for them.
amifampridineis the generic name of this product.
"Oral products heavily contaminated with yeast, mold, and aerobic bacteria may result in 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
Oral products heavily contaminated with yeast, mold, and aerobic bacteria may result in 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 product is used as a treatment for LEMS in patients ages 6 to less than 17 and is packaged in 100 count bottles (NDC: 49938-110-01). The affected Ruzurgi® (amifampridine) tablets lots include the following control numbers and expiration dates:
Control Number 18038, Expiration 03/2023
Control Number 18039, Expiration 03/2023
Control Number 18079, Expiration 05/2023
The Control Number is located to the right of the bottle’s front panel below the D2 Barcode.
Ruzurgi® (amifampridine) was distributed worldwide to specialty pharmacies and physicians.
Jacobus was informed of this issue by their Canadian partner that was conducting confirmatory full testing on Control Number 18038. Jacobus conducted an expanded investigation which identified Control Numbers 18039 and 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 product is used as a treatment for LEMS in patients ages 6 to less than 17 and is packaged in 100 count bottles (NDC: 49938-110-01). The affected Ruzurgi® (amifampridine) tablets lots include the following control numbers and expiration dates:
Control Number 18038, Expiration 03/2023
Control Number 18039, Expiration 03/2023
Control Number 18079, Expiration 05/2023
The Control Number is located to the right of the bottle’s front panel below the D2 Barcode.
Ruzurgi® (amifampridine) was distributed worldwide to specialty pharmacies and physicians.
Jacobus was informed of this issue by their Canadian partner that was conducting confirmatory full testing on Control Number 18038. Jacobus conducted an expanded investigation which identified Control Numbers 18039 and 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"
"Jacobus Pharmaceutical Company Inc. Issues Voluntary Worldwide Recall of Ruzurgi® (amifampridine) 10 mg Tablets Due to Yeast, Mold, and Bacterial Contamination"
Complete FDA information:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jacobus-pharmaceutical-company-i...
Blogs & Forums
