FDA-Drug2022-08-24Class II

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

Nephron Sc Inc
Hazard

cGMP Deviations: deviations leading to potential cross-contamination.

Sold states
USA Nationwide
Affected count
5040 vials
Manufactured in
4500 12th Street Ext, West Columbia, SC, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1354-2022

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