Recalls / Class II
Class IID-0278-2015
Product
Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7902-09.
- Affected lot / code info
- Lot # 34-017-JT; Exp. 10/15 Lot # 35-100-JT; Exp. 11/15
Why it was recalled
Lack of Assurance of Sterility: Potential of punctures through the overwrap and primary container which may result in IV bag leaks.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 836,460 bags
- Distribution pattern
- Nationwide, Puerto Rico, and U.S. Virgin Islands.
Timeline
- Recall initiated
- 2014-10-14
- FDA classified
- 2014-11-25
- Posted by FDA
- 2014-12-03
- Terminated
- 2015-12-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0278-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.