Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
Summary
The FDA issued a Class I for Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultraso by Scrip Inc. Reason: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination..
Details
Source
Device Recall
External ID
Z-0225-2022
Action Date
2021-11-24
Status
Ongoing
Category
device
Product Description
Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
Lot/Code Info: Item Number: 663 0019, all lots distributed between August 2018 and August 2021
Quantity Affected: 1001 gallons
Reason for Recall
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Distribution
US Nationwide Distribution to all 50 states.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-18
Company
Peoria, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 144 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Scrip Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Scrip Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Scrip Inc have FDA actions?
Scrip Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0225-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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