Recalls / Class II
Class IID-407-2014
Product
0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, Irvine, CA 92614. NDC 0264-7802-00.
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDCs
- 0264-7800, 0264-7802
- FDA application
- NDA019635
- Affected lot / code info
- Lot No. J3D548, expiry: Oct, 2015
Why it was recalled
Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
Recalling firm
- Firm
- B. Braun Medical Inc
- Manufacturer
- B. Braun Medical Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2525 McGaw Ave, Irvine, California 92614-5841
Distribution
- Quantity
- 19,572 bags
- Distribution pattern
- Nationwide in the US and Puerto Rico.
Timeline
- Recall initiated
- 2013-11-27
- FDA classified
- 2014-01-10
- Posted by FDA
- 2014-01-22
- Terminated
- 2014-11-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-407-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.