FDAClass IIIMarch 18, 2015

Simvastatin Tablets recall: Impurity Out of Spec

Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA…

Why was Simvastatin Tablets recalled?

Failed Impurities/Degradation Specifications: Product failed a known impurity specification.

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?

Lot #: STDG010, Exp 3/2015

Product
Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA…
Recalling firm
Micro Labs Usa, Inc S
Quantity
13488 bottles
Distribution
Nationwide.
Recall date
March 18, 2015
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls