Home / Recalls / Sandoz Incorporated / D-152-2013

D-152-2013 Class III Terminated

Recalled by Sandoz Incorporated — Broomfield, CO

Recall Details

Product Type
Drugs
Report Date
February 13, 2013
Initiation Date
January 22, 2013
Termination Date
May 7, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17,188 cartons containing 3 cards each.

Product Description

Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ

Reason for Recall

Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.

Distribution Pattern

Nationwide

Code Information

LF01215A, Exp 02/2014

Other recalls by Sandoz Incorporated

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  • D-0236-2017 Class II — Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured (December 22, 2016)
  • D-0291-2015 Class III — Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz (December 5, 2014)
  • D-1509-2014 Class II — Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, (July 25, 2014)
  • D-383-2014 Class II — Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in (October 22, 2013)
  • D-66373-001 Class III — Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle (September 25, 2013)
  • D-854-2013 Class III — Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, (August 7, 2013)
  • D-805-2013 Class II — Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X2 (June 21, 2013)
  • D-597-2013 Class II — Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, singl (May 30, 2013)