The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1842-2019·Announced 2019-09-04

Aurobindo Recalls Simvastatin Tablets Due to Incorrect Lot and Expiration Dates

Aurobindo Pharma USA Inc. is recalling 2,352 bottles of 40 mg Simvastatin tablets because some bottles were labeled with the wrong lot number and expiration date.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, and the issue is limited to labeling errors.

Plain-English summary

Aurobindo Pharma USA Inc. is recalling 2,352 bottles of Simvastatin Tablets, USP 40 mg (NDC 65862-053-99). The recall is due to a labeling error where some bottles were labeled with lot number 05318054B and an expiration date of 3/2021, instead of the correct lot number 05318034B.

The affected product was distributed nationwide by three major distributors, who may have further distributed the product. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

Consumers and healthcare providers should check their inventory for bottles with lot number 05318054B and expiration date 3/2021. If found, these products should be returned to the distributor or the manufacturer for credit. Patients should contact their healthcare provider for guidance on obtaining replacement medication.

The recalled product

Product
SIMVASTATIN (SIMVASTATIN)
Brand
SIMVASTATIN
Manufacturer
Aurobindo Pharma USA Inc.
Category
Drug — Prescription Drug
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • 05318054B
  • exp 3/2021

Distribution

Distributed nationwide across the United States.

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