Drug Enforcement D-215-2013

CGMP Deviations: Shipment of product not approved for release.

Status

Terminated

Classification

Class III

Report Date

April 3, 2013

Termination Date

March 28, 2013

Product Information

Product description
Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
Product quantity
1,296 units
Reason for recall
CGMP Deviations: Shipment of product not approved for release.
Recall initiation reason
Initial firm notification
Telephone
Distribution pattern
NC

Location & Firm

Recalling firm
Hospira, Inc.
Address
600 N Field Dr Bldg J45

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-215-2013
Event ID
63242
Recall initiation date
June 21, 2012
Center classification date
March 22, 2013
Code info
Lot 16-836-FW, Exp 04/14
More code info