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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61776

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 02, 2012
Product types
Drug
Classifications
Class II
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

1 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 1

Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons containing three (3) individual blister packs

D-1397-2012
Recall number
D-1397-2012
Initiated
May 02, 2012
Classification
Class II
Status
Terminated
Quantity
100,761 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.

Code information

Lot #'s 33800226A, Exp 7/2012; 33800333A, Exp 10/2012; 33800870A, Exp 10/2012; 33802533A, Exp 4/2013; and 33802720A, Exp 8/2013

Distribution pattern

Nationwide