Multi-event December 2014 FDA Recall Simvastatin by Micro Labs Usa, Inc S
This Multi-event Class III drug recall was voluntarily initiated by Micro Labs Usa, Inc S on December 4, 2014 for the product Simvastatin. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0408-2015
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
12-04-2014
03-18-2015
13488 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
04-25-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540 NDC 42571-0040-90.
Batch or Lot Expiration Information
Lot# : STDG010, Exp 3/2015
Recall Number: D-0407-2015
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
12-04-2014
03-18-2015
240 (1000-count bottle), 26,904 (90-count bottle)
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
04-25-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# : STCG005, Exp 01/2015
Lot# : STCG011, Exp 03/2015
Lot# : STCG012, Exp 02/2015.
Recall Number: D-0409-2015
Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
12-04-2014
03-18-2015
13464 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
04-25-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# : STEG004, Exp 2/2015
Lot# : STEG006 Exp 3/2015
