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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79310

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

Open FDA event record

Event summary

Timeline bucket
March 02, 2018
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Renaissance Lakewood, LLC

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

Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10

D-0605-2018
Recall number
D-0605-2018
Initiated
March 02, 2018
Classification
Class III
Status
Terminated
Recalling firm
Renaissance Lakewood, LLC
Quantity
1277 bags

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 and Failed Stability Specifications; out of specification results for assay and water vapor permeability

Code information

Lot A060644, May 2018

Distribution pattern

Nationwide

Field note

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