Exact FDA event identifier

Event 83356

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

Open FDA event record

Event summary

Timeline bucket: July 16, 2019
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Bionpharma 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

Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, NDC 69452-116-45.

D-1519-2019

Recall number: D-1519-2019
Initiated: July 16, 2019
Classification: Class II
Status: Terminated
Recalling firm: Bionpharma Inc.
Quantity: 3,020 bottles

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0

Microbial Contamination

Potency or specification failure reason.potency_specification_failure · v1.0.0

Out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.

Code information

Lot #: 18246, Exp 09/2020

Distribution pattern

Nationwide in the USA