Daptomycin for Injection Recalled Due to Incorrect Labeling Dosage
Accord Healthcare is recalling Daptomycin for Injection labeled as 350 mg/vial but containing 500 mg/vial vials. The labeling error poses a dosing risk to patients.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity of 4. The dosing discrepancy (500 mg vs. 350 mg labeled) creates a serious risk of medication error, though no illnesses or injuries have been reported in the source text.
Plain-English summary
Accord Healthcare, Inc. is recalling Daptomycin for Injection 350 mg/vial (NDC 16729-0434-05) distributed nationwide due to a labeling mixup. Cartons labeled as containing 350 mg/vial vials were found to contain vials with 500 mg per vial instead.
This dosing discrepancy creates a risk that healthcare providers and patients may administer an incorrect dose. Daptomycin is an antibiotic used to treat serious bacterial infections, and dosing accuracy is critical to patient safety.
Patients who have received this product should contact their healthcare provider immediately. Healthcare providers who have dispensed this product should not distribute any units from lot R2200232 (expiration 01/2025) and should verify that any administered doses were appropriate.
The recalled product
- Product
- Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug — Injectable Antibiotic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: R2200232 Exp. 01/2025
Distribution
Distributed nationwide across the United States.
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