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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97821

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

Open FDA event record

Event summary

Timeline bucket
October 03, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Advanced Pharmaceutical Technology, 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

TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01

D-0258-2026
Recall number
D-0258-2026
Initiated
October 03, 2025
Classification
Class II
Status
Ongoing
Quantity
22,843 pellets

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
microbial contamination
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.

Code information

Lot #: P-22-3, Exp 06-2027

Distribution pattern

GA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece