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Open, Classified

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

FDA Recall Z-0225-2022 · Posted None

Recalling FirmScrip Inc
Recall StatusOpen, Classified
Product CodeITX
Date Initiated2021-08-18
Product Quantity1001 gallons

Reason for Recall

Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.

Firm 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].

Root Cause

Process control

Distribution Pattern

US Nationwide Distribution to all 50 states.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K962840ECOLOTION TRANSMISSION AND MASSAGE LOTIONEco-Med Pharmaceuticals, Inc. · 1996-12-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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