FDA Enforcement
Class I
Ongoing
Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
Recall: Z-0225-2022
·
Reported November 24, 2021
Enforcement
- Recall Number
- Z-0225-2022
- Event ID
- 88751
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Scrip Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- November 24, 2021
- Initiation Date
- August 18, 2021
- Classification Date
- November 17, 2021
- Address
- 9005 N Industrial Rd, N/A, Peoria, IL, 61615-1511, United States
Description
Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
Reason
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Code Info
Item Number: 663 0019, all lots distributed between August 2018 and August 2021
Distribution
US Nationwide Distribution to all 50 states.
Quantity
1001 gallons