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Phenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PH...

FDA Recall #D-1327-2016 — Class II — April 20, 2016

Recall #D-1327-2016 Date: April 20, 2016 Classification: Class II Status: Terminated

Product Description

Phenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0934-70

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Pharmakon Pharmaceuticals, Inc. — Noblesville, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

800

Distribution

Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

Code Information

All Sterile Compounded Products within Expiry

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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