D-0972-2015 Class II Terminated
FDA drug recall D-0972-2015 was initiated by Hospira Inc. on Apr 13, 2015 and is designated Class II. Reason for recall: Crystallization The recall status is terminated (terminated Dec 4, 2017).
Recall Details
- Product Type
- Drugs
- Report Date
- May 6, 2015
- Initiation Date
- Apr 13, 2015
- Termination Date
- Dec 4, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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
Reason for Recall
Crystallization
Distribution Pattern
Nationwide, Puerto Rico and Guam.
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0972-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026