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Simvastatin

FDA recalls

4 rows

Date	Company and reason	Class
Feb 6, 2023	Accord Healthcare, Inc. CGMP Deviations: recalling drug products following an FDA inspection.	Class II · Terminated
Mar 17, 2020	Aurobindo Pharma USA Inc. CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed	Class II · Terminated
Jul 28, 2019	Aurobindo Pharma USA Inc. Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B	Class III · Terminated
Dec 21, 2017	Hetero Labs, Ltd. - Unit III Presence of foreign substance: metallic razor blade was found in one bottle.	Class III · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).