Medicine recalls
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| The United States: Jacobus Pharmaceutical Company Inc. issues voluntary worldwide recall of Ruzurgi® (amifampridine) 10 mg Tablets due to yeast, mold, and bacterial contamination |
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The US Food and Drug Administration (FDA) announces that Jacobus Pharmaceutical Company Inc. is voluntarily recalling 3 lots of Ruzurgi® (amifampridine) 10 mg Tablets (Control Number: 18038, 18039, 18079) to the consumer level. The products have been found to be contaminated with yeast, mold, and aerobic bacteria based on laboratory test results.
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 increases the concern for serious infections.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jacobus-pharmaceutical-company-inc-issues-voluntary-worldwide-recall-ruzurgir-amifampridine-10-mg
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Sep 14, 2021
Issued at HKT 15:00
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