FDA Drug Recalls

Recalls / Class III

Class IIID-215-2013

Product

Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09

Affected lot / code info
Lot 16-836-FW, Exp 04/14

Why it was recalled

CGMP Deviations: Shipment of product not approved for release.

Recalling firm

Firm
Hospira, Inc.
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
600 N Field Dr Bldg J45, Lake Forest, Illinois 60045

Distribution

Quantity
1,296 units
Distribution pattern
NC

Timeline

Recall initiated
2012-06-21
FDA classified
2013-03-22
Posted by FDA
2013-04-03
Terminated
2013-03-28
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-215-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class III recall: drug · FDA Drug Recalls