FDAClass IIFebruary 9, 2022

Premier Rotaclone recall

Premier Rotaclone, Rx only

Why was Premier Rotaclone recalled?

Product stored incorrectly in temperature controlled setting instead of refrigeration.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Premier Rotaclone, Rx only
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
34 units
Distribution
US Nationwide distribution in the states of California and Massachusetts.
Recall date
February 9, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls