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Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL bag, Rx ...

FDA Recall #D-1258-2016 — Class II — April 20, 2016

Recall #D-1258-2016 Date: April 20, 2016 Classification: Class II Status: Terminated

Product Description

Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0029-01

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

150 bags

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

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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