Exact FDA event identifier

Event 82288

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

Open FDA event record

Event summary

Timeline bucket: March 01, 2019
Product types: Drug
Classifications: Class II
Statuses: Completed
Recalling firm wording: Apotex 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

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

Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Products Co. L.L.C., P.O. Box 1885, Postal Code 111, Seeb.

D-0992-2019

Recall number: D-0992-2019
Initiated: March 01, 2019
Classification: Class II
Status: Completed
Recalling firm: Apotex Inc.
Quantity: 82,705 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.

Code information

Lots: 7DY008A, 7DY009A, 7DY010A, 7DY011A, Exp. 08/2020

Distribution pattern

Nationwide in the USA.