Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC
Summary
The FDA issued a Class I for Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured f by Accord Healthcare, Inc.. Reason: Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial.
Details
Source
Drug Recall
External ID
D-0131-2023
Action Date
2023-01-25
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot: R2200232 Exp. 01/2025
Quantity Affected: Unknown
Reason for Recall
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-29
Company
Durham, NC
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 83 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Accord Healthcare, Inc. has 90 FDA actions in our database, including 90 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Accord Healthcare, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Accord Healthcare, Inc. have FDA actions?
Accord Healthcare, Inc. has 90 FDA actions in our database, including 90 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0131-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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