Exact FDA event identifier

Event 85566

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

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Event summary

Timeline bucket: April 24, 2020
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: The Harvard Drug Group

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

Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61

D-1262-2020

Recall number: D-1262-2020
Initiated: April 24, 2020
Classification: Class III
Status: Terminated
Recalling firm: The Harvard Drug Group
Quantity: 678 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed dissolution specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.

Code information

Lot #: M02199D, M02246D, Exp 5/2020

Distribution pattern

AL, FL, IA, NY, OH, TX