Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0225-2022Class I

Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue

Scrip Inc / initiated 2021-08-18 / Open, Classified / root cause: manufacturing process

Scrip Inc began a recall of Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue on . FDA classified it as Class I and gives the reason as "Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0225-2022
Classification
Class I
Status
Open, Classified
Initiated
Posted
Recalling firm
Scrip Inc
Product
Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
Product code
ITX Transducer, Ultrasonic, Diagnostic
Reason for recall
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
The recalling firm, allegromedical, issued "URGENT Action Required" correspondence on or around 10/12/2021 informing customers of the recall and to stop use of the product. If product was further distributed, customers are asked to notify additional recipients of the product recall. If you have any questions, contact VP of Operation at 630-771-7410 or email: [email protected].
Quantity in commerce
1001 gallons
Distribution
US Nationwide Distribution to all 50 states.
Product codes and lots
Item Number: 663 0019, all lots distributed between August 2018 and August 2021

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0225-2022
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0224-2022Class IOngoingVoluntary: Firm initiated
Z-0225-2022Class IOngoingVoluntary: Firm initiated