Class II · Moderate risk Ongoing
Mycophenolate Mofetil for Injection USP
Reason Presence of precipitate
PHENOL 2.5% STERILE SOLUTION in 50 mL syringe Assurance Infusion
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of sterility assurance.
What was recalled
PHENOL 2.5% STERILE SOLUTION in 50 mL syringe Assurance Infusion (713) 533-8800
- Recalling firm
- Assurance Infusion
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0762-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Phenol recalls
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Class II · Moderate risk Ongoing
Mycophenolic Acid Delayed-Release Tablets USP
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Mycophenolate Mofetil for Oral Suspension
Reason Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Class II · Moderate risk Completed
Unguentine Ointment
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment
Reason CGMP DEVIATIONS
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