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Recall Enforment Report D-0492-2024

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Aurobindo Pharma USA Inc., originally initiated on 04-24-2024 for the product Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. The product was recalled due to discoloration: dotted and yellow spots on tablets. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0492-202404-24-202405-15-2024Class II6909 bottlesClorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.Discoloration: Dotted and yellow spots on tabletsOngoing
D-0491-202404-24-202405-15-2024Class II6696 bottlesClorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.Discoloration: Dotted and yellow spots on tabletsOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
13107-282Clorazepate Dipotassium Clorazepate DipotassiumTabletOralAurolife Pharma LlcHuman Prescription Drug
13107-283Clorazepate Dipotassium Clorazepate DipotassiumTabletOralAurolife Pharma LlcHuman Prescription Drug
13107-284Clorazepate Dipotassium Clorazepate DipotassiumTabletOralAurolife Pharma LlcHuman Prescription Drug