November 2022 FDA Recall Drug by Accord Healthcare, Inc.
D-0131-2023 - Labeling mixup

This Class I drug recall was voluntarily initiated by Accord Healthcare, Inc. on November 29, 2022 for the product Drug. The FDA reported the reason for recall as labeling mixup. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0131-2023

Reason for Recall
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Initiated
11-29-2022
Reported
01-25-2023
Quantity
Unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91228
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-22-2024
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot: R2200232 Exp. 01/2025