FDA Drug Class II — Moderate

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.

Hazard

Presence of Particulate Matter: Particulate matter identified as fiber.

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
Brand
Accord Healthcare, Inc.
UPC
Lot #: M2212070 Exp. date 08/2024

Units Affected

1680 vials