FDA Enforcement
Class II
Ongoing
Stimulen Collagen Moisturizing Lotion, ST9555B
Recall: Z-2109-2021
·
Reported July 28, 2021
Enforcement
- Recall Number
- Z-2109-2021
- Event ID
- 88163
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Southwest Technologies Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- July 28, 2021
- Initiation Date
- May 28, 2021
- Classification Date
- July 21, 2021
- Address
- 1746 E Levee St, N/A, Kansas City, MO, 64116-4404, United States
Description
Stimulen Collagen Moisturizing Lotion, ST9555B
Reason
Dose audit failure after sterilization process
Code Info
Lot 2104007, EXP: 02/2024
Distribution
Malaysia
Quantity
2016 units