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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89993

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

Open FDA event record

Event summary

Timeline bucket
April 15, 2022
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Akorn, 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

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

Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04

D-0846-2022
Recall number
D-0846-2022
Initiated
April 15, 2022
Classification
Class III
Status
Terminated
Recalling firm
Akorn, Inc.
Quantity
66,744 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed viscosity specification - product was below specificcation

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed viscosity specification - product was below specificcation

Code information

Lot #: 370978, Exp 9/30/2022

Distribution pattern

Nationwide USA and Puerto Rico