Exact FDA event identifier

Event 89607

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

Event summary

Timeline bucket: February 16, 2022
Product types: Drug
Classifications: Class II
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

Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07.

D-0639-2022

Recall number: D-0639-2022
Initiated: February 16, 2022
Classification: Class II
Status: Terminated
Recalling firm: Macleods Pharma Usa Inc
Quantity: 3672 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

cGmp Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGmp Deviations

Code information

Lot #: BOB42029A, BOB4202B, Exp. Date 09/2022

Distribution pattern

Nationwide within the United States