NDC 65862-052

Simvastatin 20 mg tablet, film coated

Where it's made

Medchal, India · makes it and tests it

Problems found, fixed voluntarily Last FDA inspection Jul 21, 2023. 13 inspections on record, 1 with serious problems.

Mahabubnagar, India · makes it and tests it

Problems found, fixed voluntarily Last FDA inspection May 10, 2022. 7 inspections on record, 1 with serious problems.

Dayton, NJ, United States · makes it and tests it

Serious problems, FDA action Last FDA inspection Dec 7, 2021. 10 inspections on record, 1 with serious problems.

Taizhou, China · makes it and tests it

Not inspected on record

Mar 18, 2020 · Class II · Terminated
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Lots: Lot #: 05319004A1, Exp. Date 03/2022
Jul 29, 2019 · Class III · Terminated
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Lots: 05318054B, exp 3/2021

Generic drug: Simvastatin: see every company that makes it
Form: tablet, film coated, oral
Strength: 20 mg
Approval: ANDA ANDA077691
On the market since: Dec 20, 2006
Package NDCs: 65862-052-00 65862-052-01 65862-052-26 65862-052-30 65862-052-45 65862-052-90 65862-052-99
Official label: DailyMed (National Library of Medicine), updated May 11, 2026

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