Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ 07677 USA, Marketed by: The Medicines Company, Parsippany, NJ 07054 USA
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #V10189, Lot #V10191, Lot #V10194, Exp 01/13; Lot #V10223; Exp 02/13
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Eagle Pharmaceuticals Inc.
- Reason for Recall:
- A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ 07677 USA, Marketed by: The Medicines Company, Parsippany, NJ 07054 USA
Product Codes/Lot Numbers:
Lot #V10189, Lot #V10191, Lot #V10194, Exp 01/13; Lot #V10223; Exp 02/13
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1429-2012