Drug 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.
D-407-2014
Product summary
- Event
- Event 67095
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,572 bags
- Official record key
drug-enforcement:D-407-2014
Official wording
Reason: Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
Code information: Lot No. J3D548, expiry: Oct, 2015
Distribution pattern: Nationwide in the US and Puerto Rico.
Derived failure modes
-
Labeling or packaging
Labeling: Wrong