Exact FDA event identifier

Event 64644

4 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 15, 2013
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Teva Pharmaceuticals USA, Inc.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 4

Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, NY --- NDC 0555-9014-67

D-681-2013

Recall number: D-681-2013
Initiated: March 15, 2013
Classification: Class III
Status: Terminated
Recalling firm: Teva Pharmaceuticals USA, Inc.
Quantity: 148,785 blister packs

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Impurity/Degradation Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

Code information

NDC 0555-9014-67, Lot numbers 33802921A, exp 8/2013; 33803173A, exp 10/2013; 33803695A, exp 2/2014; and 33803942A, exp 3/2014.

Distribution pattern

Nationwide distribution. No foreign or government accounts.

drug · product 2 of 4

Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58

D-682-2013

Recall number: D-682-2013
Initiated: March 15, 2013
Classification: Class III
Status: Terminated
Recalling firm: Teva Pharmaceuticals USA, Inc.
Quantity: 47,200 blister packs

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Impurity/Degradation Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

Code information

NDC 0555-9028-58, Lot numbers 33802123A, exp 4/2013; 33802202A, exp 5/2013; 33802203A, exp 5/2013; and 33802204A, exp 5/2013.

Distribution pattern

Nationwide distribution. No foreign or government accounts.

drug · product 3 of 4

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

D-683-2013

Recall number: D-683-2013
Initiated: March 15, 2013
Classification: Class III
Status: Terminated
Recalling firm: Teva Pharmaceuticals USA, Inc.
Quantity: 54,412 blister packs

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Impurity/Degradation Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

Code information

NDC 0555-9123-66, Lot numbers 33802986A, exp 9/2013; 33802991A, exp 7/2013; and 33803270A, exp 10/2013.

Distribution pattern

Nationwide distribution. No foreign or government accounts.

drug · product 4 of 4

Balziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, NY --- NDC 0555-9034-58

D-684-2013

Recall number: D-684-2013
Initiated: March 15, 2013
Classification: Class III
Status: Terminated
Recalling firm: Teva Pharmaceuticals USA, Inc.
Quantity: 36,708 blister packs

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Impurity/Degradation Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

Code information

NDC 0555-9034-58, Lot numbers 33802100A, exp 3/2013; 33802266A, exp 3/2013; and 33802832A, exp 8/2013.

Distribution pattern

Nationwide distribution. No foreign or government accounts.