April 2012 FDA Recall Jolessa by Teva Pharmaceuticals Usa, Inc.
D-1384-2012 - Contraceptive Tablets Out of Sequence

This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc. on April 23, 2012 for the product Jolessa. The FDA reported the reason for recall as contraceptive tablets out of sequence. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1384-2012

Reason for Recall
Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.
Initiated
04-23-2012
Reported
06-27-2012
Quantity
40,750 Dispensers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61759
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-23-2013
Product Description About Product Description
Full technical description of the product.
Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health, Manufactured by: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66.

Batch or Lot Expiration Information

Lot# 's 33801826A, Exp 1/2013; 33802144A; 33802323A, Exp 3/2013; 33802519A, Exp 6/2013

Affected Packages Involved in this Recall

0555-9123-66 Jolessa