On December 22, 2022, the U.S. Food and Drug Administration (FDA) reported Accord Healthcare, Inc.’s, voluntarily recall of a single lot of daptomycin for injection 500 mg and 350 mg vials at the consumer level because vials labeled as “daptomycin for injection 500 mg/vial” were found in cartons labeled “daptomycin for injection 350 mg/vial.”
Administration of higher-than-intended doses of daptomycin to at-risk populations, such as children or patients with renal impairment, could result in serious adverse health consequences. If reactions occur, they may require medical treatment, such as hemodialysis and systemic glucocorticoids.
To date, Accord Healthcare, Inc., has not received any reports of adverse events related to the recall.
The following products are included in the recall:
|
Product |
NDC |
Lot Number/Expiration Date |
|
Daptomycin for injection, 500 mg per vial |
16729-435-05 |
R2200232, 01/2025 |
|
Daptomycin for injection, 350 mg per vial |
16729-434-05 |
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.”
Accord Healthcare, Inc., said it is notifying wholesalers and distributors via letter and arranging for return of all recalled products. Wholesalers and distributors that have the recalled product should discontinue distribution and follow the instructions to return.
Consumers with questions regarding the recall can contact Accord Healthcare, Inc., by phone at 855-869-1081, by fax at 817-868-5362, or by email at rxrecalls@inmar.com Monday–Friday from 8 am–5 pm EST. Consumers should contact their physician or healthcare provider if they experience any problems that may be related to taking or using the recalled product.
Healthcare professionals and consumers should report any adverse reactions or quality problems with the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.