Home / Recalls / Micro Labs Usa, Inc S / D-0046-2015

D-0046-2015 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
November 5, 2014
Initiation Date
October 9, 2014
Termination Date
December 29, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,328 bottles

Product Description

GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540

Reason for Recall

Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.

Distribution Pattern

CT, FL, MD, MS, NY

Code Information

GLBG001 Exp.12/14, GLBG008 Exp. 06/15

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-0253-2015 Class II — LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufacture (September 22, 2014)
  • D-0246-2015 Class III — Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Mic (August 19, 2014)