Why it was recalled
Subpotent Drug: Heparin raw material was found to have low potency
Product description
Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx only, Manufactured for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015 by Baxter Healthcare Corporation 250 Road 144 Jayuya, Puerto Rico, 00664, NDC 0338-0431-03
Lot numbers, UPCs & expiration codes
Lot #: N003061; N003079; and N003087, Exp 2/29/2016
Where it was sold
Nationwide
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-0276-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 30, 2014
- FDA report date
- Dec 3, 2014
- Quantity
- 127,746 Viaflex Plus Container
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-0276-2015, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69634
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: N003061; N003079; and N003087, Exp 2/29/2016
- Postal code
- 60015-4625
- Report date
- Dec 3, 2014
- Product type
- Drugs
- Recall number
- D-0276-2015
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 127,746 Viaflex Plus Container
- Termination date
- Sep 22, 2016
- Reason for recall
- Subpotent Drug: Heparin raw material was found to have low potency
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx only, Manufactured for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015 by Baxter Healthcare Corporation 250 Road 144 Jayuya, Puerto Rico, 00664, NDC 0338-0431-03
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 30, 2014
- Initial firm notification
- Letter
- Center classification date
- Nov 24, 2014