FDA recall D-1842-2019

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-07-29

Report date

2019-09-04

Termination date

2021-10-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1842-2019