Z-1653-2012

Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is a non-sterile gel...

Name: Z-1653-2012 Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is a non-sterile gel...
Creator: Pharmaceutical Innovations, Inc.
Published: 2012-03-02
License: https://open.fda.gov/license/

Pharmaceutical Innovations, Inc. / initiated 2012-03-02 / Terminated / root cause: manufacturing process

FDA source

Pharmaceutical Innovations, Inc. began a recall of Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the... on 2012-03-02. The reason FDA records is "Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination. An FDA Safety Communication was issued for this product on April 18, 2012". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1653-2012
Status: Terminated
Initiated: 2012-03-02
Posted: 2012-05-24
Terminated: 2021-07-19
Recalling firm: Pharmaceutical Innovations, Inc.
Product: Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
Product code: MUI Media, Coupling, Ultrasound
Reason for recall: Other-Sonic GENERIC ULTRASOUND TRANSMISSION GEL is being recalled due to possible microbial contamination. An FDA Safety Communication was issued for this product on April 18, 2012.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Phamaceutical Innovations Inc. sent an Urgent Message Notice letter dated March 02, 2012 with a followup letter dated March 9, 2012 and an Inventory Withdrawal letter dated March 23, 2012 via email and fax to all affected customers. Customers were instructed to examinne inventory, refrain from distribution and return remaining inventory for a replacement. For questions call 973-242-2900.
Quantity in commerce: 40,164 units in distribution worldwide - unable to obtain units in distribution Nationwide
Distribution: Worldwide Distribution - United States (nationwide) including the states of: FL, MA, MS, NJ, OH, TN and VA, and the countries of: Canada and Australia.
Product codes and lots: 060111 080111 090111 100811

Product code MUI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)