Recalls / Class I
Class ID-0392-2015
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 600045, NDC 0409-7929-09
- Affected lot / code info
- Lot # 35-118- JT, Exp. 11/15
Why it was recalled
Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 142,644 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-07-10
- FDA classified
- 2015-02-17
- Posted by FDA
- 2015-02-25
- Terminated
- 2015-11-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0392-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.