Scrip Creme ultrasound lotion recalled for bacterial contamination
Scrip Creme All Purpose Lotion is being recalled due to bacterial contamination in this ultrasound coupling lotion. The product—1001 gallons in lots distributed between August 2018 and August 2021—was distributed nationwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I designation for potential bacterial contamination in a medical device with direct skin and tissue contact. No illnesses or injuries have been reported, but the Class I classification reflects the serious potential health hazard.
Plain-English summary
Scrip Inc is recalling Scrip Creme All Purpose Lotion (Item Number 663 0019), manufactured by Eco-Med Pharmaceutical, Inc. The lotion is used as an acoustic coupling agent for ultrasound transducers during medical procedures. A total of 1001 gallons in lots distributed between August 2018 and August 2021 are affected, distributed nationwide to all 50 states.
The recalled lotion may contain bacterial contamination, which could pose a health risk when the gel comes into direct contact with skin and tissue during ultrasound procedures.
The FDA has classified this as a Class I recall. Consumers and healthcare facilities should immediately discontinue use of this product. Anyone who has used this lotion or has concerns about potential exposure should contact Scrip Inc or their healthcare provider.
The recalled product
- Product
- Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
- Manufacturer
- Scrip Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Item Number: 663 0019
- all lots distributed between August 2018 and August 2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Scrip Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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