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

Recall date

July 29, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1842-2019

FDA classification

Class III

Brand / firm

Aurobindo Pharma USA Inc.

Sold / distributed

Product was distributed nationwide by three major distributors who may have further distributed the product.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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