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Terminated

Inactivated macrolide-resistant Mycoplasma genitalium

FDA Recall Z-0955-2022 · Posted None

Recalling FirmMicrobiologics Inc
Recall StatusTerminated
Product CodeOHQ
Date Initiated2022-03-22
Date Terminated2023-01-09
Product Quantity2 ea

Reason for Recall

The QC process was not adequate for the specification range.

Firm Action

A customer letter, dated 03/24/2022, was issued to the impacted consignee via email. The consignee is instructed to destroy the product as it is now past its updated expiration date. The consignee is asked to complete the response form and submit to the recalling firm.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of NV and VT.

Official Source

View FDA Recall →

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

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