FDA-Drug2020-04-22Class II

Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90

Aurobindo Pharma USA Inc.
Hazard

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Sold states
Nationwide within the United States
Affected count
26976 units
Manufactured in
279 Princeton Hightstown Rd, East Windsor, NJ, United States
Products
Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1234-2020

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