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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93044

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

Open FDA event record

Event summary

Timeline bucket
September 12, 2023
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Tolmar, 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

Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75, Manufactured by: Tolmar Inc., Fort Collins, CO 80526, For Tolmar Therapeutics Inc., Fort Collins, CO 80526.

D-1178-2023
Recall number
D-1178-2023
Initiated
September 12, 2023
Classification
Class III
Status
Terminated
Recalling firm
Tolmar, Inc.
Quantity
2990 cartons

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 - Higher than expected levels of leuprolide acetate in the constituted product.

Code information

Lot: 13635A1, Exp. 07/31/2024

Distribution pattern

Nationwide in the US.