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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61759

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

Open FDA event record

Event summary

Timeline bucket
April 23, 2012
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

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

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.

D-1384-2012
Recall number
D-1384-2012
Initiated
April 23, 2012
Classification
Class III
Status
Terminated
Quantity
40,750 Dispensers

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Contraceptive Tablets Out of Sequence: This recall has been initiated due to the potential that some regimen packages may not contain placebo tablets.

Code information

Lot #'s 33801826A, Exp 1/2013; 33802144A; 33802323A, Exp 3/2013; 33802519A, Exp 6/2013

Distribution pattern

Nationwide