Home / Recalls / Micro Labs Usa, Inc S / D-0407-2015

D-0407-2015 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
March 18, 2015
Initiation Date
December 4, 2014
Termination Date
April 25, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
240 (1000-count bottle), 26,904 (90-count bottle)

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.

Distribution Pattern

Nationwide.

Code Information

Lot #: STCG005, Exp 01/2015; Lot #: STCG011, Exp 03/2015; Lot #: STCG012, Exp 02/2015.

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-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)
  • D-0246-2015 Class III — Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Mic (August 19, 2014)