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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79580

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

Open FDA event record

Event summary

Timeline bucket
February 21, 2018
Product types
Drug
Classifications
Class II
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

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902, By: Claris Injectables Limited, Sarkhei-Bavla Road, Chacharwadi-Vasna, Ahmedabad, India 382213, NDC 36000-002-10

D-0696-2018
Recall number
D-0696-2018
Initiated
February 21, 2018
Classification
Class II
Status
Terminated
Recalling firm
Renaissance Lakewood, LLC
Quantity
1784 bags

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Label mix-up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.

Code information

Lot #: A0A0539, Exp. 05/19

Distribution pattern

Product was distributed throughout the United States.