Recalls / Class II
Class IID-0976-2016
Product
Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-836-11, Service Code 2K5836.
- Affected lot / code info
- Lot# 161300033M, Exp 07/26/16
Why it was recalled
Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506
Distribution
- Quantity
- 240 bags
- Distribution pattern
- NY
Timeline
- Recall initiated
- 2016-05-16
- FDA classified
- 2016-06-09
- Posted by FDA
- 2016-06-15
- Terminated
- 2016-06-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0976-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.