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Terminated

Premier Rotaclone, Rx only

FDA Recall Z-0552-2022 · Posted None

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusTerminated
Product CodeLIQ
Date Initiated2021-12-01
Date Terminated2023-02-13
Product Quantity34 units

Reason for Recall

Product stored incorrectly in temperature controlled setting instead of refrigeration.

Firm Action

Medline notified consignees on 12/01/2021, via first class mail letter titled URGENT RECALL NOTIFICATION. Customers were instructed to immediately check stock for affected product, quarantine any affected product on hand, complete and return the response form indicating product destroyed, and notify customers if the product was further distributed. An amended customer letter was sent on 12/17/2021. The explanation of the issue was updated. Instructions remained the same.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of California and Massachusetts.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K852969ROTACLONE ROTAVIRUS DIAGNOSTIC KITCambridge Bioscience Corp. · 1985-11-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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