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Aurobindo Pharma USA Inc. recalls Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufac

Recalled September 4, 2019 · FDA recall D-1842-2019 · Aurobindo Pharma USA

Hazard
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B · FDA Class III
Units
2,352/1000 count bottles
Sold at
Product was distributed nationwide by three major distributors who may have further distributed the product.

Description

Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B

Product
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
Manufacturer(s)
Aurobindo Pharma USA Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov