Exact FDA event identifier

Event 82198

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

Event summary

Timeline bucket: February 15, 2019
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Heritage 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

Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals Inc. Made in India, NDC 23155-160-31

D-1065-2019

Recall number: D-1065-2019
Initiated: February 15, 2019
Classification: Class II
Status: Terminated
Recalling firm: Heritage Pharmaceuticals, Inc.
Quantity: 11888 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug.

Code information

Lot #: AMA701, Exp. March 2019; AMA702, AMA703, Exp August 2019.

Distribution pattern

Nationwide within the United States