Product Safety Recalls

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SIMVASTATIN Recall D-0523-2023

Description: Simvastatin Tablets, USP, 80 mg, 90-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-9429-9

SIMVASTATIN Recall D-0523-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0523-2023
Event ID91952
Active SubstanceSIMVASTATIN
Drug RouteORAL
DistributionUSA Nationwide
Quantity57 Bottles
Recall ReasoncGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Drug ClassificationClass II
Drug Code Info20230412
Product NDC68788-9429 68788-9747 68788-9869
Product NUIN0000175589 N0000000121
Pharma Class (EPC)HMG-CoA Reductase Inhibitor [EPC]
Recall Initiation Date20230323
Report Date20230412
Classification Date20230406
Address1250 N Lakeview Ave Ste O
Anaheim, CA 92807-1801
United States
Recalling FirmPreferred Pharmaceuticals, Inc.
Initial Notification Letter
Unique Ingredient IdentifierAGG2FN16EV
Drug Application NumberANDA078155
Structured Product Labeling (SPL ID)a6a377c0-6795-4d61-8c65-678cfdf04aaf
Structured Product Labeling (SPL Set ID)7442f35f-74e8-4c35-9666-190a3baad549
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