Home / Recalls / Pharmakon Pharmaceuticals / D-0871-2016

D-0871-2016 Class I Terminated

Recalled by Pharmakon Pharmaceuticals — Noblesville, IN

FDA drug recall D-0871-2016 was initiated by Pharmakon Pharmaceuticals on Feb 11, 2016 and is designated Class I. Reason for recall: Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj. The recall status is terminated (terminated May 16, 2017). Affected quantity: 75 Syringes.

Recall Details

Product Type: Drugs
Report Date: Jun 1, 2016
Initiation Date: Feb 11, 2016
Termination Date: May 16, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 75 Syringes

Product Description

Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.

Reason for Recall

Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.

Distribution Pattern

IN and IL

Code Information

Lot #: E52418EV11C, Exp 03/19/2016

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0871-2016
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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