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ATORVASTATIN CALCIUM TRIHYDRATE Recall D-0726-2022

Description: Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90

ATORVASTATIN CALCIUM TRIHYDRATE Recall D-0726-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0726-2022
Event ID89833
BrandATORVASTATIN CALCIUM
Generic NameATORVASTATIN CALCIUM
ManufacturerATORVASTATIN CALCIUM
Original Package?1
Active SubstanceATORVASTATIN CALCIUM TRIHYDRATE
Drug RouteORAL
DistributionNationwide in the USA.
Quantity28,068 bottles
Recall ReasonFailed Impurities/Degradation Specifications: Out of Specification results for related substance.
Drug ClassificationClass III
Drug Code Info20220406
Product NDC55111-124
Recall Initiation Date20220316
Report Date20220406
Classification Date20220329
Address107 College Rd E
Princeton, NJ 08540-6623
United States
Recalling FirmDr. Reddy's Laboratories, Inc.
Initial Notification Letter
Unique Ingredient Identifier48A5M73Z4Q
Drug Application NumberANDA202357
Structured Product Labeling (SPL ID)3ec2bef7-b820-857f-1c70-e57c2d2c6dbf
Structured Product Labeling (SPL Set ID)6ccdb6f3-22c7-5b48-46bc-ce4a4c65eb4d
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