0.45% Sodium Chloride Injection USP recall: Labeling Error
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.
Why was 0.45% Sodium Chloride Injection USP recalled?
Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot No. J3D548, expiry: Oct, 2015
- 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.
- Recalling firm
- B. Braun Medical Inc
- Quantity
- 19,572 bags
- Distribution
- Nationwide in the US and Puerto Rico.
- Recall date
- January 22, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)