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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64643

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

Open FDA event record

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

Complete imported group

Every recalled product in this event

2 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 2

Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58

D-689-2013
Recall number
D-689-2013
Initiated
March 15, 2013
Classification
Class III
Status
Terminated
Quantity
154,536 cartons

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

Lot #s: 33801773A, Exp 7/14; 33801774A, Exp 8/14; 33801775A, 33801776A, Exp 9/14; 33802427A, 33802428A, 33802429A, 33802430A, Exp 12/14; 33802925A, 33802926A, Exp 3/15; 33803383A, 33803384A, 33803385A, 33803387A, 33803685A, Exp 6/15.

Distribution pattern

Nationwide and Puerto Rico

drug · product 2 of 2

Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0715-58

D-690-2013
Recall number
D-690-2013
Initiated
March 15, 2013
Classification
Class III
Status
Terminated
Quantity
59,240 Cartons

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

Lot #s: 33802107A, 33802108A, Exp 9/13; 33802109A, 33802110A, 33802111A, 33802112A, Exp10/13; 33802560A, Exp 1/14.

Distribution pattern

Nationwide and Puerto Rico