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.
Reported: July 19, 2023 Initiated: July 3, 2023 #D-0918-2023
Product Description
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.
Reason for Recall
Presence of Particulate Matter: Particulate matter identified as fiber.
Details
- Recalling Firm
- Accord Healthcare, Inc.
- Units Affected
- 1680 vials
- Distribution
- Nationwide within the United States
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Accord Healthcare, Inc.. Units affected: 1680 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Particulate matter identified as fiber.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 19, 2023. Severity: Moderate. Recall number: D-0918-2023.
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