Reported Mar 8, 2023 · Terminated
Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8;…
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 350 mg/vial, Rx only
- Packaged asa) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8; b) 10 Single-dose vials NDC 16729-434-45
- UPC 3 16729 43445 4 Manufactured byIntas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
- Lot codes and dates
9 of 9 products
Products covered by this recall # Product as published 1 R2101274, Exp. Date 9/30/2023 2 R2200161, Exp. Date 1/31/2025 3 R2200506, Exp. Date 1/31/2025 4 R2200697, Exp. Date 4/30/2025 5 R2201107, Exp. Date 7/31/2025 6 R2101471, Exp. Date 9/30/2023 7 R2200588, Exp. Date 4/30/2025 8 R2201333, Exp. Date 7/31/2025 9 R2201361, Exp. Date 8/31/2025 - Amount recalled
- 65,233 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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