Class II · Moderate risk Ongoing
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan…
Reason Presence of precipitate
Is Phenol recalled?
41 FDA recalls mention Phenol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Phenol.
Class II · Moderate risk Ongoing
Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD…
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771…
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, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) tubes…
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide…
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal…
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
PHENOL 10% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Terminated
Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
PHENOL 2.5% STERILE SOLUTION in 50 mL syringe Assurance Infusion (713) 533-8800
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
S-PHENOL 6% INJ SOLN, Rx Only 10ml glass vial, Red Mountain Compounding Rx.
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
S-DEXTROSE/GLYCERIN/PHENOL 25/25/2.5% INJ SOLN, 30 ml glass vial, Rx Only, Red Mountain Compounding Rx
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
C-PHENOL/COTTONSEED OIL INJ 5%, 5 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Reason Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class I · High risk Terminated
Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut…
Reason Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
Class II · Moderate risk Terminated
Phenol 10% Injection, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1432-10
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenol 5% and Glycerin Aqueous Solution 10 mL Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1431-10
Reason Lack of Assurance of Sterility
Class I · High risk Terminated
Dr. King's SafeCare Rx Allergies: Fragrances & Phenolics, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC…
Reason Microbial contamination
Class I · High risk Terminated
Dr. King's Natural Medicine Homeopathic Fragrance & Phenolic Allergy Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr…
Reason Microbial contamination
Class II · Moderate risk Terminated
Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
VI PEEL (Sal Acid 2%, TCA 17%, Phenol 7%, Retinoic Acid 0.4%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
QUAD PEEL (Sal Acid 2%, TCA 7%, Phenol 7%, Retinoic acid 0.4%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
GENERIC VI PEEL (Sal Acid 2%, TCA 7% Phenol 7%, Retinoic Acid 0.4%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA…
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Class II · Moderate risk Terminated
MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%, Phenol 0.5%, 1 oz.. (28 g) tube, Made in China, Distributed by Cherry Hill…
Reason CGMP Deviations
Class III · Low risk Terminated
Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing…
Reason cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
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