Exact FDA event identifier

Event 78446

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

Event summary

Timeline bucket: November 06, 2017
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Claris Lifesciences 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

Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: Claris LifeScience Inc. North Brunswick NJ 08902 by Claris Injectables Ltd. Gujarat, India UPC 336000008242 NDC 36000-008-249

D-0127-2018

Recall number: D-0127-2018
Initiated: November 06, 2017
Classification: Class III
Status: Terminated
Recalling firm: Claris Lifesciences Inc
Quantity: Unavailable

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

Code information

A060192 01/2018; A060305 02/2018; A061038 08/2018; A0A0068 12/2018; A0A0404 04/2019

Distribution pattern

Nationwide