Home / Recalls / Pharmakon Pharmaceuticals / D-0596-2016

D-0596-2016 Class II Terminated

Recalled by Pharmakon Pharmaceuticals — Noblesville, IN

FDA drug recall D-0596-2016 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: 7100.

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: 7100

Product Description

Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, 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-0596-2016
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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