FDA MedWatch – Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial Lot by Accord

TOPIC: Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial Lot by Accord Healthcare: Recall – Due to Product Mix-Up

AUDIENCE: Dermatology, Health Professional, Pediatrics, Pharmacy

ISSUE: Accord Healthcare is recalling a single lot of Daptomycin for Injection 500 mg/vial, and Daptomycin for Injection 350 mg/vial product contained in cartons imprinted with lot # R2200232 Exp: 01/2025 to the consumer/user level. This product is being recalled because Accord 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”.

Risk Statement: Administration of Daptomycin 500 mg/vial, to the population most at risk which are children or patients with renal impairment, there is a reasonable probability that the likelihood of the labeled warnings can potentially be increased if a higher than the intended dose is used which could lead to serious adverse health consequences. If these reactions occur, they may require medical treatment such as hemodialysis and systemic glucocorticoids. 

For more information about this recall/alert, click on the red button “Read Recall” below.

BACKGROUND: Daptomycin is used for the treatment of adult and pediatric patients (1 to 17 years of age) with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureaus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).

RECOMMENDATIONS: 

• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

• Any questions regarding this recall, contact the company.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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