FDA recall D-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

Reason for recall

Crystallization

Distribution

Nationwide, Puerto Rico and Guam.

Key facts

Status

Terminated

Initiation date

2015-04-13

Report date

2015-05-06

Termination date

2017-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0973-2015