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

FDA recall notice · announced August 24, 2022 · Nephron Sc

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

cGMP Deviations: deviations leading to potential cross-contamination.

Notes

Distribution: USA Nationwide
Lot/code information: Lot#: 023011 Exp 8/31/2022
Quantity: 5040 vials
Status: Terminated
Products in this recall event:
- 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 048 (D-1354-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.