Home / Recalls / Pharmakon Pharmaceuticals / D-0594-2016

D-0594-2016 Class II Terminated

Recalled by Pharmakon Pharmaceuticals — Noblesville, IN

FDA drug recall D-0594-2016 was initiated by Pharmakon Pharmaceuticals on Aug 19, 2015 and is designated Class II. Reason for recall: Stability data does not support expiry. The recall status is terminated (terminated May 9, 2017). Affected quantity: 4100.

Recall Details

Product Type: Drugs
Report Date: Feb 3, 2016
Initiation Date: Aug 19, 2015
Termination Date: May 9, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4100

Product Description

Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.

Reason for Recall

Stability data does not support expiry.

Distribution Pattern

Nationwide

Code Information

All lots with expiration dates up to 11/17/2015

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0594-2016
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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