FDA Recall
Terminated
Inactivated macrolide-resistant Mycoplasma genitalium
Recall: Z-0955-2022
·
Initiated March 22, 2022
Recall
- Recall Number
- Z-0955-2022
- Event Number
- 89887
- Firm
- Microbiologics Inc
- FEI Number
- 2150138
- Product Code
- OHQ
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- March 22, 2022
- Terminated
- January 9, 2023
- Address
- 200 Cooper Ave N, Saint Cloud, MN, 56303-4440
Description
Inactivated macrolide-resistant Mycoplasma genitalium
Reason
The QC process was not adequate for the specification range.
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.
Distribution
US Nationwide distribution in the states of NV and VT.
Quantity
2 ea