Recalls / Class I
Class ID-263-2013
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
Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.
- Affected lot / code info
- Lot # :12-160-JT*, Exp 12/01/13; lot number * may be followed by 01 or 90
Why it was recalled
Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 136,224 flexible containers
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-10-05
- FDA classified
- 2013-04-17
- Posted by FDA
- 2013-04-24
- Terminated
- 2015-08-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-263-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.