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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89670

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

Open FDA event record

Event summary

Timeline bucket
February 22, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
American Health Packaging

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

Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus, OH 43217. UPC (01) 003 60687 406 40 4; Case NDC#: 60687-406-77, Unit Dose NDC#: 60687-406-40

D-0652-2022
Recall number
D-0652-2022
Initiated
February 22, 2022
Classification
Class II
Status
Terminated
Recalling firm
American Health Packaging
Quantity
89,880 unit-dose cups

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Impurity failure at 0-time of the repackaged lot.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Impurity failure at 0-time of the repackaged lot.

Code information

Lot# 1004276, Exp 11/30/2022

Distribution pattern

Nationwide in the USA