FDA recall Z-0552-2022
MEDLINE INDUSTRIES, LP - Northfield · Class II · device
Product
Premier Rotaclone, Rx only
Reason for recall
Product stored incorrectly in temperature controlled setting instead of refrigeration.
Distribution
US Nationwide distribution in the states of California and Massachusetts.
Key facts
- Status
- Terminated
- Initiation date
- 2021-12-01
- Report date
- 2022-02-09
- Termination date
- 2023-02-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0552-2022