Drug product
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01
D-1354-2022
Product summary
- Firm
- Nephron Sc Inc
- Event
- Event 90703
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5040 vials
- Official record key
drug-enforcement:D-1354-2022
Official wording
Reason: cGMP Deviations: deviations leading to potential cross-contamination.
Code information: Lot#: 023011 Exp 8/31/2022
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations: deviations