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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79849

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

Open FDA event record

Event summary

Timeline bucket
April 09, 2018
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
LEADIANT BIOSCIENCES, 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

Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amityville, NY 11701 for Leadiant Biosciences, Inc. Gaithersburg, MD 20878, NDC 54482-020-01

D-0683-2018
Recall number
D-0683-2018
Initiated
April 09, 2018
Classification
Class III
Status
Terminated
Recalling firm
LEADIANT BIOSCIENCES, INC
Quantity
3,398 bottles

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.

Code information

lot numbers: 35866, Exp 6/18; 358663, Exp 7/18

Distribution pattern

Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany