FDA-Drug2019-09-04Class III
Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99
Aurobindo Pharma USA Inc.
Hazard
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Sold states
Product was distributed nationwide by three major distributors who may have further distributed the product.
Affected count
2,352/1000 count bottles
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1842-2019Don't want to check this manually?
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