Accord Healthcare Inc. has issued a voluntary nationwide recall of a single lot of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial due to a product mix-up. The affected lot # R2200232 was distributed in cartons with an expiry date of 01/2025.
The consumer-level recall was initiated after a hospital reported that cartons labeled Daptomycin for Injection 500 mg/vial were found to contain Daptomycin for Injection 350 mg/vial.
Risk Statement
Administering a higher dose of Daptomycin Injection of 350 mg/vial, especially to kids or patients with renal impairment, could result in an increased risk of adverse events, including serious infections due to resistant organisms and impairment of kidney function.
Patients who react to the medication may need immediate treatment, like hemodialysis and systemic glucocorticoids.
Daptomycin is used to treat adults and children with certain bacterial infections such as skin and soft tissue infections, bone and joint infections, complicated bloodstream infections (including those caused by Staphylococcus aureus bacteremia), and others.
Accord Healthcare Inc. is notifying its distributors and customers by letter and asking that they return any remaining product from the affected lot to the place of purchase.
Users can identify the affected products by the outer carton and inner vial labels. The table below contains the full information about the recalled product:
| Product | NDC | Lot number/Expiration Date |
| Daptomycin for Injection 500 mg/vial | 16729-435-05 | R2200232, 01/2025 |
| Daptomycin for Injection 350 mg/vial | 16729-434-05 |
Patients should contact their healthcare provider if they have any questions regarding this recall or have been treated with Daptomycin for an Injection of 350 mg/vial instead of the prescribed 500 mg/vial.
Healthcare providers should stop administering the affected product and return any remaining product to their place of purchase. Wholesalers and distributors are also advised to stop the distribution of the remaining stock.
Consumers with questions regarding this recall can contact Accord Healthcare Inc. by sending an email to [email protected] or calling 1-855-869-1081, faxing: 1-817-868-5362, Monday through Friday between 8:00 a.m. to 5:00 pm EST.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
To report by phone, call 1-800-332-1088. To report by mail or fax, download and complete the form found at www.fda.gov/MedWatch/getforms.htm or use the address or fax number provided at the bottom of page 2 of the Medwatch 3500 form and submit it to your local FDA office.
