Status
Terminated
Drug Enforcement D-407-2014
Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
Classification
Class II
Report Date
January 22, 2014
Termination Date
November 1, 2014
Product Information
- Product description
- 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.
- Product quantity
- 19,572 bags
- Reason for recall
- Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the US and Puerto Rico.
Location & Firm
- Recalling firm
- B. Braun Medical Inc
- Address
-
2525 McGaw Ave
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-407-2014
- Event ID
- 67095
- Recall initiation date
- November 27, 2013
- Center classification date
- January 10, 2014
- Code info
- Lot No. J3D548, expiry: Oct, 2015
- More code info
- —