Home / Recalls / Watson Laboratories Inc / D-014-2013

D-014-2013 Class II Terminated

Recalled by Watson Laboratories Inc — Corona, CA

Recall Details

Product Type
Drugs
Report Date
October 31, 2012
Initiation Date
October 19, 2012
Termination Date
November 21, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
67,860 cartons

Product Description

Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc., Parsippany, NJ 07054 USA; NDC 52544-949-28.

Reason for Recall

Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: 517921AA, 517921AB, 517922AA, 517922AB, 517923AA, 517923AB, Exp 03/31/14

Other recalls by Watson Laboratories Inc

  • D-1053-2014 Class II — Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 c (January 15, 2014)
  • D-397-2014 Class II — Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured (December 23, 2013)
  • D-66360-001 Class II — Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 (September 23, 2013)
  • D-66251-001 Class II — Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, R (September 13, 2013)
  • D-1061-2013 Class III — Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Cou (August 30, 2013)
  • D-823-2013 Class III — Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bo (July 19, 2013)
  • D-205-2013 Class II — ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 table (February 13, 2013)
  • D-204-2013 Class II — Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Watson (February 8, 2013)
  • D-203-2013 Class II — Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Watson (February 8, 2013)
  • D-094-2013 Class III — Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0 (December 13, 2012)