Simvastatin Tablets recall: Impurity Out of Spec
Simvastatin Tablets, USP, 10 mg, 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 Impurity content (Butylated Hydroxy Anisole Content) against shelf life 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 #: STBG005, Exp 2/2015
- Product
- Simvastatin Tablets, USP, 10 mg, 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
- 1,008 bottles
- Distribution
- NY
- Recall date
- November 19, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)