FDA-Drug2023-07-19Class II
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67.
Accord Healthcare, Inc.
Hazard
Presence of Particulate Matter: Particulate matter identified as fiber.
Sold states
Nationwide within the United States
Affected count
1680 vials
Manufactured in
1009 Slater Rd Ste 210B, N/A, Durham, NC, United States
Products
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0918-2023Don't want to check this manually?
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