Recalls / Class II
Class IID-1354-2022
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
- Brand name
- Ketorolac Tromethamine
- Generic name
- Ketorolac Tromethamine
- Active ingredient
- Ketorolac Tromethamine
- Route
- Intramuscular
- NDC
- 0487-6232
- FDA application
- ANDA211445
- Affected lot / code info
- Lot#: 023011 Exp 8/31/2022
Why it was recalled
cGMP Deviations: deviations leading to potential cross-contamination.
Recalling firm
- Firm
- Nephron Sc Inc
- Manufacturer
- Nephron Pharmaceuticals Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4500 12th Street Ext, West Columbia, South Carolina 29172-3025
Distribution
- Quantity
- 5040 vials
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2022-08-10
- FDA classified
- 2022-08-17
- Posted by FDA
- 2022-08-24
- Terminated
- 2024-09-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1354-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.