Accord Healthcare Inc. Issues Nationwide Voluntary Recall of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial Lot # R2200232 Due to Product Mix-up

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.”

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 in the table below:

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.

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.

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.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Source: Bio Space