FDA Drug Recalls

Recalls / Class II

Class IID-0827-2016

Product

Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7918-19, Barcode (01) 0 030409 791819 5

Affected lot / code info
Lot# 48-010-JT, Exp 12/16

Why it was recalled

Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.

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
11256 bags
Distribution pattern
US: Nationwide and Singapore

Timeline

Recall initiated
2016-03-08
FDA classified
2016-04-21
Posted by FDA
2016-04-27
Terminated
2017-12-06
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0827-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.