Recall: D-1842-2019

Class III - Minor Violations

Class IIIClassification

2019-07-29Initiated

TerminatedStatus

Aurobindo Pharma USA Inc.Firm

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

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.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.