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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88696

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

Open FDA event record

Event summary

Timeline bucket
September 15, 2021
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

Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 Case NDC#: 60687-262-56; Individual Dose NDC: 60687-262-42

D-0854-2021
Recall number
D-0854-2021
Initiated
September 15, 2021
Classification
Class II
Status
Terminated
Recalling firm
American Health Packaging
Quantity
548 ccases

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: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

Code information

Lot 1000082; Exp 06/30/2022

Distribution pattern

Nationwide USA