Exact FDA event identifier

Event 84571

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

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Event summary

Timeline bucket: December 26, 2019
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Lupin Pharmaceuticals 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

Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pithampur 454775 INDIA 240875, NDC 68180-866-11

D-0638-2020

Recall number: D-0638-2020
Initiated: December 26, 2019
Classification: Class II
Status: Terminated
Recalling firm: Lupin Pharmaceuticals Inc.
Quantity: 41,863 cartons/3 wallets per carton

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.

Code information

Lot: H801227, Exp. Date January 2020

Distribution pattern

Nationwide within the United States