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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68610

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

Open FDA event record

Event summary

Timeline bucket
June 17, 2014
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Teva Pharmaceuticals USA

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

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

Apri (desogestrel and ethinyl estradiol tablets USP), 0.15 mg/0.03 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA. NDC 0555-9043-58

D-1436-2014
Recall number
D-1436-2014
Initiated
June 17, 2014
Classification
Class III
Status
Terminated
Recalling firm
Teva Pharmaceuticals USA
Quantity
1104 blister packs

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: out of specification impurity test results.

Code information

Lot 3805324A Exp. 11/14

Distribution pattern

Nationwide

drug · product 2 of 4

Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58

D-1437-2014
Recall number
D-1437-2014
Initiated
June 17, 2014
Classification
Class III
Status
Terminated
Recalling firm
Teva Pharmaceuticals USA
Quantity
984 blister packs

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: out of specification impurity test results.

Code information

Lot 33805507A, Exp. date 11/14

Distribution pattern

Nationwide

drug · product 3 of 4

Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only, Teva Pharmaceuticals, Sellersville, PA NDC 0555-9050-58

D-1438-2014
Recall number
D-1438-2014
Initiated
June 17, 2014
Classification
Class III
Status
Terminated
Recalling firm
Teva Pharmaceuticals USA
Quantity
1125 blister packs

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: out of specification impurity test results.

Code information

Lot 33805325A, Exp.11/14

Distribution pattern

Nationwide

drug · product 4 of 4

Velivet (desogestrel and ethinyl estradiol tablets - triphasic regimen), 0.1 mg/0.025 mg; 0.125 mg/0.025 mg; 0.15 mg/0.025 mg, 3 Dispensers x 28 Tablets, Barr Laboratories, Inc., Pomona, NY NDC 0555-9051-67

D-1439-2014
Recall number
D-1439-2014
Initiated
June 17, 2014
Classification
Class III
Status
Terminated
Recalling firm
Teva Pharmaceuticals USA
Quantity
5265 blister packs

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: out of specification impurity test results.

Code information

Lot 33805449A, Exp. 12/14

Distribution pattern

Nationwide