Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Inactivated macrolide and quinolone-resistant Mycoplasma genitalium

FDA Recall Z-0954-2022 · Posted None

Recalling FirmMicrobiologics Inc
Recall StatusTerminated
Product CodeOHQ
Date Initiated2022-03-24
Date Terminated2023-01-09
Product Quantity1 ea

Reason for Recall

QC process was not adequate for the specification range.

Firm Action

A customer letter, dated 03/24/2022, was emailed to the impacted consignee. 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 state of TX.

Official Source

View FDA Recall →

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

↑