Recalls / Class II
Class IID-0256-2015
Product
Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.
- Brand name
- Potassium Chloride
- Generic name
- Potassium Chloride
- Active ingredient
- Potassium Chloride
- Route
- Intravenous
- NDCs
- 0338-0703, 0338-0705, 0338-0709
- FDA application
- NDA019904
- Affected lot / code info
- Lot #: P319160, Exp 06/30/15
Why it was recalled
Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 63,360 container bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-11-10
- FDA classified
- 2014-11-21
- Posted by FDA
- 2014-12-03
- Terminated
- 2016-11-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0256-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.