Recalls / Class I
Class ID-0957-2016
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDCs
- 0338-0043, 0338-0049
- FDA application
- NDA018016
- Affected lot / code info
- Lot # C980227; Exp. 11/16
Why it was recalled
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
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
- 255,852 VIAFLEX Plastic Containers
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-12-15
- FDA classified
- 2016-06-06
- Posted by FDA
- 2016-06-15
- Terminated
- 2022-04-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0957-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.