Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Go...
FDA Recall #D-0409-2015 — Class III — December 4, 2014
Product Description
Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-080-90.
Reason for Recall
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Recalling Firm
Micro Labs Usa, Inc S — Princeton, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
13464 bottles
Distribution
Nationwide.
Code Information
Lot #: STEG004, Exp 2/2015; Lot #: STEG006 Exp 3/2015
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated