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Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0....

FDA Recall #D-0334-2019 — Class II — December 5, 2018

Recall #D-0334-2019 Date: December 5, 2018 Classification: Class II Status: Terminated

Product Description

Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732. NDC 61553-148-48

Reason for Recall

Sub-potent

Recalling Firm

Pharmedium Services, LLC — Lake Forest, IL

Classification

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

Product Type

Drugs

Product Quantity

295 100 mL in 150 mL Intravia bags

Distribution

Nationwide in the USA.

Code Information

Lot: 183230004C Exp. 02/17/2019

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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