D-0973-2015 Class II Terminated
FDA drug recall D-0973-2015 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, 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 Pattern
Nationwide, Puerto Rico and Guam.
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0973-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026