Recalls / Class I
Class ID-1108-2015
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 IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.
- Affected lot / code info
- Lot # 40-008-JT; Exp. 04/01/16
Why it was recalled
Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 24,744 flexible container bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-03-11
- FDA classified
- 2015-05-28
- Posted by FDA
- 2015-06-03
- Terminated
- 2017-01-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1108-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.