Class II · Moderate risk Ongoing
Mycophenolate Mofetil for Injection USP
Reason Presence of precipitate
Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials…
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 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
- Recalling firm
- Guardian Pharmacy Services
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1073-2018
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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