Recalls / Class I
Class ID-1593-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822.
- 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 #: P309476, Exp 10/14
Why it was recalled
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
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
- 171,672 bags
- Distribution pattern
- Nationwide, Puerto Rico, Singapore, and Hong Kong
Timeline
- Recall initiated
- 2014-07-11
- FDA classified
- 2014-09-18
- Posted by FDA
- 2014-09-24
- Terminated
- 2016-09-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1593-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.