Drug 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
D-0973-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 71002
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0973-2015
Official wording
Reason: Crystallization
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
Distribution pattern: Nationwide, Puerto Rico and Guam.
Derived failure modes
-
Unknown
Crystallization