FDAClass IIISeptember 4, 2019

Simvastatin Tablets recall: Labeling Error

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

Why was Simvastatin Tablets recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

05318054B, exp 3/2021

Product
Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma…
Recalling firm
Aurobindo Pharma USA Inc.
Quantity
2,352/1000 count bottles
Distribution
Product was distributed nationwide by three major distributors who may have further distributed the product.
Recall date
September 4, 2019
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls