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Premier Rotaclone, Rx only

FDA Recall #Z-0552-2022 — Class II — December 1, 2021

Recall #Z-0552-2022 Date: December 1, 2021 Classification: Class II Status: Terminated

Product Description

Premier Rotaclone, Rx only

Reason for Recall

Product stored incorrectly in temperature controlled setting instead of refrigeration.

Recalling Firm

MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL

Classification

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

Product Type

Devices

Product Quantity

34 units

Distribution

US Nationwide distribution in the states of California and Massachusetts.

Code Information

Model Number: RID696004, Lot Number 696004N116, Expiration Date 01/12/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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