Recalls / Class II
Class IID-0276-2015
Product
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
- Brand name
- Heparin Sodium In Sodium Chloride
- Generic name
- Heparin Sodium
- Active ingredient
- Heparin Sodium
- Route
- Intravenous
- NDCs
- 0338-0424, 0338-0431, 0338-0433, 0338-0428
- FDA application
- NDA018609
- Affected lot / code info
- Lot #: N003061; N003079; and N003087, Exp 2/29/2016
Why it was recalled
Subpotent Drug: Heparin raw material was found to have low potency
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 127,746 Viaflex Plus Container
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-10-30
- FDA classified
- 2014-11-24
- Posted by FDA
- 2014-12-03
- Terminated
- 2016-09-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0276-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.