Home / Recalls / Greenstone Llc / D-011-2014

D-011-2014 Class II Terminated

Recalled by Greenstone Llc — Peapack, NJ

Recall Details

Product Type
Drugs
Report Date
November 27, 2013
Initiation Date
September 4, 2013
Termination Date
April 13, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4848 bottles

Product Description

Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5012-1

Reason for Recall

Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: V121211, Exp 03/31/2017

Other recalls by Greenstone Llc

  • D-0299-2026 Class II — methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton contain (January 15, 2026)
  • D-1361-2014 Class I — Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, (March 6, 2014)
  • D-746-2014 Class II — sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Distrib (November 5, 2013)
  • D-1059-2014 Class III — Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx (November 4, 2013)
  • D-737-2014 Class II — Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, Dis (November 1, 2013)
  • D-010-2014 Class II — Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Gr (September 4, 2013)