Exact FDA event identifier

Event 79849

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

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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