Reported Mar 8, 2023 · Terminated
Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited,…
Accord Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accord Healthcare, Inc. · 1009 Slater Rd Ste 210B · Durham, NC · 27703-8446
Is this the product you have?
- Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only
- Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-435-05 UPC 3 16729 43505 5
- Lot codes and dates
- Batches
R2101282Exp. Date 9/30/2023R2101600Exp. Date 11/30/2024R2200002R2200028R2200116R2200142R2200152Exp. Date 12/31/2024R2200165R2200190Exp. Date 1/31/2025R2201042Exp. Date 7/31/2025
- Batches
- Amount recalled
- 228,760 vials
This recall covers 67 products
The agency filed one notice per product. You are reading one of them; the other 66 are below.
54 more are in the archive.
Where it was sold
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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