Recalls / Class II
Class IID-1606-2014
Product
Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Baxter USA, product code 2B0826, NDC 0338-0709-48.
- 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 P318220, EXP 05/31/15
Why it was recalled
Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.
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
- 148632 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-09-08
- FDA classified
- 2014-09-23
- Posted by FDA
- 2014-10-01
- Terminated
- 2016-09-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1606-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.