August 2014 FDA Recall Simvastatin by Micro Labs Usa, Inc S
D-0246-2015 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Micro Labs Usa, Inc S on August 19, 2014 for the product Simvastatin. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in NY and the recall is currently terminated.
Recall Number: D-0246-2015
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
08-19-2014
11-19-2014
1,008 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Micro Labs Usa, Inc S
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
NY
04-19-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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 Inc., Princeton, NJ 08540, NDC 42571-010-90
Batch or Lot Expiration Information
Lot# : STBG005, Exp 2/2015
