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KETOROLAC TROMETHAMINE Recall D-1354-2022

Description: 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

KETOROLAC TROMETHAMINE Recall D-1354-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1354-2022
Event ID90703
BrandKETOROLAC TROMETHAMINE
Generic NameKETOROLAC TROMETHAMINE
ManufacturerKETOROLAC TROMETHAMINE
Original Package?1
Active SubstanceKETOROLAC TROMETHAMINE
Drug RouteINTRAMUSCULAR
DistributionUSA Nationwide
Quantity5040 vials
Recall ReasoncGMP Deviations: deviations leading to potential cross-contamination.
Drug ClassificationClass II
Drug Code Info20220824
Product NDC0487-6232
Recall Initiation Date20220810
Report Date20220824
Classification Date20220817
Address4500 12th Street Ext
West Columbia, SC 29172-3025
United States
Recalling FirmNephron Sc Inc
Initial Notification Letter
Unique Ingredient Identifier4EVE5946BQ
Drug Application NumberANDA211445
Structured Product Labeling (SPL ID)cf6e2f84-03b0-7f12-e053-2995a90aac06
Structured Product Labeling (SPL Set ID)ae6c60c0-e88a-45b2-e053-2995a90ac62f
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