Recall Z-1970-2019

Reason for recall

Potential for failed stability antimicrobial effectiveness testing.

FDA-determined cause: Other

Action taken

On June 21,2019, Pharmaceutical Innovations issued Urgent Medical Device notices to customers via email. Customers were instructed to do the following: 1) Examine inventory, Isolate and quarantine these products. 2) Notify any end users, customers or additional facilities within your organization to discontinue use and sale and quarantine those products until final disposition has been determined and performed. 3) Return the MEDICAL DEVICE RECALL RETURN RESPONSE form to James Hurlman at Pharmaceutical Innovations, Inc, email : jimh@pharminnovations.com, Fax:973-242-0578. 4) Pharmaceutical Innovations, Inc. will send you a confirmation of receipt of the Recall Return Response Form for your records. 5) An RMA (Return Material Authorization) or LOD (Letter of Destruction) will be issued as requested by you in the Recall Return Response Form. The RMA will have instructions on how to return the product. 6) All LOD requests must be accompanied by photographs of actual product to receive credit and or reimbursement. Customers with questions may contact the firm Monday through Friday, 8:30 AM to 3:30 PM, Eastern Time. Phone: 973-242-2900 Fax:973-242-0578 Email: jimh@pharminnovations.com