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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0224-2022 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-0225-2022 | Class I | Ongoing | Voluntary: Firm initiated |
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