Accord Healthcare is voluntarily recalling 1 lot of Daptomycin for Injection 500mg/vial, and Daptomycin for Injection 350mg/vial to the consumer level due to a product mix-up.
According to a product complaint report from a hospital pharmacy, vials labeled as “Daptomycin for Injection 500mg/vial” were found in cartons labeled as “Daptomycin for Injection 350mg/vial”. The lot and expiration date on the outer carton and inner vial are the same and correspond to “Daptomycin for Injection 500mg/vial”.
The recalled lot number of R2200232; Expiration Date 1/2025 for both Daptomycin for Injection 500mg/vial; NDC Number 16729-435-05 and Daptomycin for Injection 350mg/vial; NDC Number 16729-434-05 were distributed nationwide to wholesalers. Daptomycin is indicated for the treatment of susceptible complicated skin and skin structure infections in adults and pediatric patients and Staphylococcus aureus bacteremia in adult patients.
The administration of the affected lot of Daptomycin for Injection 500mg/vial, particularly in children or patients with renal impairment, may lead to a “reasonable probability that the likelihood of the labeled warnings can potentially be increased if a higher than intended dose is used.” At this time, the Company has not received any reports of adverse events related to this recall.
Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.
Accord Healthcare Inc. issues nationwide voluntary recall of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial Lot # R2200232 due to product mix-up. News release. Accord Healthcare Inc. December 23, 2022. Accessed December 27, 2022. https://www.prnewswire.com/news-releases/accord-healthcare-inc-issues-nationwide-voluntary-recall-of-daptomycin-for-injection-500-mgvial-and-daptomycin-for-injection-350-mgvial-lot–r2200232-due-to-product-mix-up-301709694.html.