Jolessa Kit
FDA Recall NDC 0555-9123
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Jolessa (NDC 0555-9123). A significant event, classified as Class III, was initiated on Mar 15, 2013 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
March 2013 Class III Recall: Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Recall Number
Class III Terminated
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Mar 15, 2013
Jul 17, 2013
54,412 blister packs
Recall Profile & Regulatory Data
Event ID
64644
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide distribution. No foreign or government accounts.
Termination Date
Apr 10, 2014
Product Description
Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sellersville, PA ---NDC 0555-9123-66
Batch or Lot Expiration Information
Lot# NDC 0555-9123-66, Lot numbers 33802986A, exp 9/2013; 33802991A, exp 7/2013; and 33803270A, exp 10/2013.
Affected Packages Involved in this Recall
0555-9123-66Product
Class III Terminated
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Mar 12, 2013
Apr 17, 2013
71,893 dispensers
Recall Profile & Regulatory Data
Event ID
64607
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jan 15, 2014
Product Description
Jolessa (levonorgestrel/ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 91-count tablets per extended-cycle tablet dispenser packaged in 3 dispensers per carton, Rx only, 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# : 33803603A, 33803604A, Exp 11/13; 33803996A, and 33803997A, Exp 03/14
Affected Packages Involved in this Recall
0555-9123-66Product
Class III Terminated
Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.
Apr 23, 2012
Jun 27, 2012
40,750 Dispensers
Recall Profile & Regulatory Data
Event ID
61759
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 23, 2013
Product Description
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
0555-9123-66Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
