Durham, North Carolina-based Accord Healthcare, Inc. is recalling a single lot of Daptomycin for Injection in two doses citing product mix-up, the U.S. Food and Drug Administration said.
The recall involves all of lot #R2200232 of Daptomycin for Injection 500 mg/vial, and Daptomycin for Injection 350 mg/vial product contained in cartons with Exp: 01/2025 to the consumer/user level.
The recall was initiated after the company received a product complaint report from a hospital pharmacy that vials labeled as "Daptomycin for Injection 500 mg/vial" were found in cartons labeled as "Daptomycin for Injection 350 mg/vial".
However, the lot and expiration date printed on the outer carton and inner vial are the same and correspond to "Daptomycin for Injection 500 mg/vial."
According to the company, Daptomycin for Injection 500 mg/vial may be in outer cartons that read "Daptomycin for Injection 500 mg/vial" OR "Daptomycin for Injection 350 mg/vial." The products were distributed nationwide to wholesale.
The injection is given to the population most at risk which are children or patients with renal impairment. With the administration of Daptomycin 500 mg/vial, there is a reasonable probability that a higher than the intended dose could lead to serious adverse health consequences.
If these reactions occur, they may require medical treatment such as hemodialysis and systemic glucocorticoids. However, Accord has not received any reports of adverse events related to the recall to date.
The product is used for the treatment of adult and pediatric patients with complicated skin and skin structure infections caused by susceptible isolates of the Gram-positive bacteria.
Wholesalers and Distributors that have the recalled product are asked to discontinue distribution of the product.
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