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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95590

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

Open FDA event record

Event summary

Timeline bucket
October 21, 2024
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
BLI International, 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

Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24

D-0029-2025
Recall number
D-0029-2025
Initiated
October 21, 2024
Classification
Class II
Status
Terminated
Recalling firm
BLI International, Inc.
Quantity
4,901 cases/24 count each case

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug: Stability failure for assay at 6 months test time-point.

Code information

Lot # 24A27724, Exp 01/31/2027

Distribution pattern

Product was shipped to two private label customers ( OH & MO) as a final packaged product.