FDA Recall
Terminated
Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Recall: Z-0954-2022
·
Initiated March 24, 2022
Recall
- Recall Number
- Z-0954-2022
- Event Number
- 89886
- Firm
- Microbiologics Inc
- FEI Number
- 2150138
- Product Code
- OHQ
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- March 24, 2022
- Terminated
- January 9, 2023
- Address
- 200 Cooper Ave N, Saint Cloud, MN, 56303-4440
Description
Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Reason
QC process was not adequate for the specification range.
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.
Distribution
US Nationwide distribution in the state of TX.
Quantity
1 ea