The Recall Desk
SevereFDA (Devices)·Z-0225-2022·Announced 2021-11-24

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
  • bacterial-contamination

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.