Exact FDA event identifier

Event 84749

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

Event summary

Timeline bucket: January 20, 2020
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Macleods Pharma 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

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

Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10

D-0823-2020

Recall number: D-0823-2020
Initiated: January 20, 2020
Classification: Class III
Status: Terminated
Recalling firm: Macleods Pharma Usa Inc
Quantity: 10680 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product

Code information

Lot #: BMD8901B, Exp. Date 02/2021

Distribution pattern

Nationwide within the United States