Home / Recalls / Micro Labs Usa, Inc S / D-0246-2015

D-0246-2015 Class III Terminated

Recalled by Micro Labs Usa, Inc S — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
November 19, 2014
Initiation Date
August 19, 2014
Termination Date
April 19, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,008 bottles

Product Description

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

Reason for Recall

Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.

Distribution Pattern

NY

Code Information

Lot #: STBG005, Exp 2/2015

Other recalls by Micro Labs Usa, Inc S

  • D-0408-2015 Class III — Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micr (December 4, 2014)
  • D-0407-2015 Class III — Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-coun (December 4, 2014)
  • D-0409-2015 Class III — Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micr (December 4, 2014)
  • D-0046-2015 Class II — GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 c (October 9, 2014)
  • D-0253-2015 Class II — LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufacture (September 22, 2014)