Accord Healthcare Inc. Recalls Single Lot of Daptomycin for Injection


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daptomycin

Daptomycin


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”. 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:-

Daptomycin for Injection 500 mg/vial | 16729-435-05 | R2200232, 01/2025

Daptomycin for Injection 350 mg/vial | 16729-434-05 | R2200232, 01/2025

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 product can be identified by the outer carton and inner vial as given in the image above.

Daptomycin for Injection 350 mg/vial and 500 mg/vial were distributed nationwide to wholesale.

Accord is notifying or has notified its Wholesalers and Distributors by letter and is arranging for return of all recalled products. Wholesalers and Distributors that have product which is being recalled should discontinue distribution of the product.

Source: FDA

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Consumer Contact: –

For any questions regarding this recall, contact Accord Healthcare, Inc. by phone at 1-855-869-1081, fax: 1-817-868-5362 or e-mail at rxrecalls@inmar.com Monday to Friday during business hours 8 am to 5 pm EST. 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.

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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.


Report a Problem With This Product

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.

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This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

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This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

You Are Leaving Us

This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.

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This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.

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