Product Safety Recalls

Product Recall Tracker

SIMVASTATIN Recall D-0411-2023

Description: Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000-count tablets NDC 16729-006-17, UPC 3 16729 00617 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

SIMVASTATIN Recall D-0411-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0411-2023
Event ID91657
Original Package?1
Active SubstanceSIMVASTATIN
Drug RouteORAL
DistributionUnited States including Puerto Rico and Canada
Quantity1,190,484 bottles
Recall ReasonCGMP Deviations: recalling drug products following an FDA inspection.
Drug ClassificationClass II
Drug Code Info20230308
Product NDC16729-004 16729-005 16729-006
Product NUIN0000175589 N0000000121
Drug UPC0316729156103 316729006156 316729006170
Pharma Class (EPC)HMG-CoA Reductase Inhibitor [EPC]
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 IdentifierAGG2FN16EV
Drug Application NumberANDA078155
Structured Product Labeling (SPL ID)ed1b03bb-2300-1f49-e053-2995a90a0052
Structured Product Labeling (SPL Set ID)871251c0-36a1-4a32-9eab-ff6c1e925ca9
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