Potassium Chloride for Injection Concentrate USP recall: Sterility Concern
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC…
Why was Potassium Chloride for Injection Concentrate USP recalled?
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
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 #: J2S007, Exp: 12/31/2024; J3A115, Exp: 01/31/2025.
- Product
- Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC…
- Recalling firm
- B. Braun Medical Inc
- Quantity
- 22,752 bags
- Distribution
- Nationwide in the USA
- Recall date
- March 20, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)