Product Safety Recalls

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ATORVASTATIN CALCIUM TRIHYDRATE Recall D-0371-2023

Description: Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,000 Tablets NDC 16729-044-17 UPC 3 16729 04417 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA.

ATORVASTATIN CALCIUM TRIHYDRATE Recall D-0371-2023 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0371-2023
Event ID91657
BrandATORVASTATIN CALCIUM
Generic NameATORVASTATIN CALCIUM
ManufacturerATORVASTATIN CALCIUM
Original Package?1
Active SubstanceATORVASTATIN CALCIUM TRIHYDRATE
Drug RouteORAL
DistributionUnited States including Puerto Rico and Canada
Quantity256,106 bottles
Recall ReasonCGMP Deviations: recalling drug products following an FDA inspection.
Drug ClassificationClass II
Drug Code Info20230308
Product NDC16729-044 16729-045 16729-046
Drug UPC316729044158 316729044172
Recall Initiation Date20230207
Report Date20230308
Classification Date20230302
Address1009 Slater Rd Ste 210B
Durham, NC 27703-8446
United States
Recalling FirmAccord Healthcare, Inc.
Initial Notification Letter
Unique Ingredient Identifier48A5M73Z4Q
Drug Application NumberANDA207687
Structured Product Labeling (SPL ID)c724ae44-1c23-e3c9-e053-2a95a90a5c79
Structured Product Labeling (SPL Set ID)4e06b20d-cc5d-46eb-991b-5972248de3af
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