Recalls / Class II

Class IID-0973-2015

Product

Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3796-01 --- Also labeled under NOVAPLUS label NDC 00409-3796-49

Affected lot / code info

Lot 38-135-DK, 38-136-DK Exp. Date 1FEB2016; Lots 44-075-DK, 44-356-DK Exp. Date 1AUG2016; Lots 44-357-DK, 44-358-DK Exp. Date 1AUG2016; Lot 46-308-DK Exp. Date 1OCT2016 - Note: The lot number may be followed by additional numbers from 01 to 99 NOVAPLUS label Lot 38-137-DK Exp. Date 1FEB2016 - 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-0973-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.