Accord Daptomycin for Injection - recalled due to mislabeling, USA
1 year ago •source www.fda.gov
Recall notice
United States
Durham, North Carolina, Accord Healthcare, Inc. is voluntarily 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”. These products were distributed to wholesale nationwide in the USA.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.” Accordingly, Accord is voluntarily recalling all of lot #R2200232, Daptomycin for Injection 500 mg/vial, which may be in outer cartons that read “Daptomycin for Injection 500 mg/vial” OR “Daptomycin for Injection 350 mg/vial.”
- Affected products:
Product: Daptomycin for Injection 500 mg/vial
NDC: 16729-435-05
Lot number/Expiration Date: R2200232, 01/2025
Product: Daptomycin for Injection 350 mg/vial
NDC: 16729-434-05
Lot number/Expiration Date: R2200232, 01/2025
Company name: Accord Healthcare, Inc
Brand name: Accord
Product recalled: Daptomycin for Injection
Reason of the recall: Mislabeling
FDA Recall date: December 27, 2022
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. To date, Accord has not received any reports of adverse events related to this recall.
The product 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).
The lot number, NDC number and expiration date of affected Daptomycin 500 mg/vial and Daptomycin 350 mg/vial product is shown below:
Product: Daptomycin for Injection 500 mg/vial
NDC: 16729-435-05
Lot number/Expiration Date: R2200232, 01/2025
Product: Daptomycin for Injection 350 mg/vial
NDC: 16729-434-05
Lot number/Expiration Date: R2200232, 01/2025
In case you experienced harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.
Source: www.fda.gov
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