Why it was recalled
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.
Product 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
Lot numbers, UPCs & expiration codes
Lot #V10189, Lot #V10191, Lot #V10194, Exp 01/13; Lot #V10223; Exp 02/13
Where it was sold
New Jersey
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1429-2012
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 2, 2011
- FDA report date
- Aug 8, 2012
- Quantity
- 19,660 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eagle Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1429-2012, exactly as published.
Show all FDA fields
- City
- Woodcliff Lake
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 61108
- Address
- 470 Chestnut Ridge Rd
- Code information
- Lot #V10189, Lot #V10191, Lot #V10194, Exp 01/13; Lot #V10223; Exp 02/13
- Postal code
- 07677-7604
- Report date
- Aug 8, 2012
- Product type
- Drugs
- Recall number
- D-1429-2012
- Classification
- Class I
- Recalling firm
- Eagle Pharmaceuticals Inc.
- Product quantity
- 19,660 vials
- Termination date
- Jun 3, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- New Jersey
- Recall initiation date
- Dec 2, 2011
- Initial firm notification
- Letter
- Center classification date
- Jul 31, 2012