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Class III · Lower riskRecall completed

Simvastatin

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot number05318054B, exp 3/2021
Where it was soldProduct was distributed nationwide by three major distributors who may have further distributed the product.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810
Brand nameSIMVASTATIN
Generic nameSIMVASTATIN
Active ingredient(s)SIMVASTATIN
Distributed by / forAurobindo Pharma USA, Inc. Dayton, NJ 08810
NDC65862-053-99
Show the full FDA record
Full product labelSimvastatin 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
Recalling firmAurobindo Pharma USA Inc.
DistributionProduct was distributed nationwide by three major distributors who may have further distributed the product.
Quantity2,352/1000 count bottles
Recall initiated2019-07-29
Report date2019-09-04
Recall completed2021-10-28
Recall numberD-1842-2019
ClassificationClass III
FDA statusTerminated
Origin on fileEast Windsor NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.