Recalls / Class II

Class IID-0972-2015

Product

Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3795-01--- Also labeled under NOVAPLUS label NDC 00409-3795-49

Affected lot / code info

Lots 35-231-DK, 35-235-DK, 35-507-DK Exp. Date 1NOV2015; Lot 36-136-DK Exp. Date 1DEC2015; Lot 37-146-DK Exp. Date 1JAN2016; Lot 38-138-DK Exp. Date 1FEB2016; Lots 39-103-DK, 39-255-DK Exp. Date 1MAR2016; Lots 40-539-DK, 40-549-DK, Exp. Date 1APR2016; Lot 41-079-DK Exp. Date 1MAY2016; Lots 42-252-DK, 42-254-DK Exp. Date 1JUN2016; Lots 43-262-DK, 43-263-DK Exp. Date 1JUL2016; Lots 45-031-DK, 45-032-DK, 45-033-DK Exp. Date 1SEP2016; Lot 46-001-DK Exp. 1OCT2016 - Note: The lot number may be followed by additional numbers from 01 to 99 NOVAPLUS label Lot 35-230-DK Exp. Date 1NOV2015; Lot 40-535-DK Exp. Date 1APR2016 - Note: The lot number may be followed by additional numbers from 01 to 99

Why it was recalled

Crystallization

Recalling firm

Firm

Hospira Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

600 N Field Dr, Lake Forest, Illinois 60045-4835

Distribution

Distribution pattern

Nationwide, Puerto Rico and Guam.

Timeline

Recall initiated

2015-04-13

FDA classified

2015-04-28

Posted by FDA

2015-05-06

Terminated

2017-12-04

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0972-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.