Exact FDA event identifier

Event 87152

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

Event summary

Timeline bucket: January 08, 2021
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Taro Pharmaceuticals U.S.A., 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

Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672-4001-1

D-0246-2021

Recall number: D-0246-2021
Initiated: January 08, 2021
Classification: Class II
Status: Terminated
Recalling firm: Taro Pharmaceuticals U.S.A., Inc.
Quantity: 44,256 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

AC05096, AC05098, and AC05099; Exp 10/31/2022

Distribution pattern

Nationwide