FDA-Device2022-02-09Class II

Premier Rotaclone, Rx only

Hazard

Product stored incorrectly in temperature controlled setting instead of refrigeration.

Sold states
US Nationwide distribution in the states of California and Massachusetts.
Affected count
34 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Premier Rotaclone, Rx only

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0552-2022

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