Recalls / Class II
Class IID-1131-2015
Product
Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- 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
- Product Code: 280953 Lots: N002998 and N003004 exp 12/31/15; and lot N003038 exp. 01/31/2016
Why it was recalled
Subpotent Drug; out of specification results for heparin raw material
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
- 145,350 containers
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-06-03
- FDA classified
- 2015-06-09
- Posted by FDA
- 2015-06-17
- Terminated
- 2017-03-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1131-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.