Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 425...
FDA Recall #D-0407-2015 — Class III — December 4, 2014
Product Description
Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540
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
240 (1000-count bottle), 26,904 (90-count bottle)
Distribution
Nationwide.
Code Information
Lot #: STCG005, Exp 01/2015; Lot #: STCG011, Exp 03/2015; Lot #: STCG012, Exp 02/2015.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated