Recalls / Class II
Class IID-1128-2018
Product
0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18
- 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 #: P380287, Exp. date 12/2019
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 33600 bags
- Distribution pattern
- TX and MS only
Timeline
- Recall initiated
- 2018-08-21
- FDA classified
- 2018-08-27
- Posted by FDA
- 2018-09-05
- Terminated
- 2019-10-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1128-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.