July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls Levocarnitine 500mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls Inositol/Choline B12 + Carnitine 40mg/40mg/1mg/100mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls Hydroxocobalamin Preservative Free 5mg/mL, 1mL-vial, Refrigerate, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls Hydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls Gonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls Glycyrrhizic Acid 8mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls Glutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-vial, Refrigerate, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls Dexpanthenol Preservative Free 250mg/mL, 2mL-vial, Room Temperature, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls Dexpanthenol 250mg/mL, 30mL-vial, Room Temperature, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls Calcium Chloride Preservative Free, 100mg/mL, a) 5 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls Biotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls BCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls Ascorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, Room Temperature, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL, 3mL-vial, Refrigerate, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
TMC Acquisition LLC dba Tailor Made Compounding recalls Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Hazard: Lack of Assurance of Sterility
July 20, 2022DrugsFDA
Vi-Jon, LLC recalls Hydrogen Peroxide Topical Solution, USP, 32 fl. oz. (1 QT) 946 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woon
Hazard: Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However, the product inside the bottle is 70% Isopropyl Alcohol.
July 20, 2022DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun Pharmaceutic
Hazard: cGMP - Water leakage
July 20, 2022DrugsFDA
Jubilant Draximage Inc recalls Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per cart
Hazard: Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
July 20, 2022DrugsFDA
Bryant Ranch Prepack, Inc. recalls Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc
Hazard: Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
July 20, 2022DrugsFDA
Bryant Ranch Prepack, Inc. recalls Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc
Hazard: Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
July 13, 2022DrugsFDA
Wedgewood Village Pharmacy, LLC recalls Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro,
Hazard: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
July 13, 2022DrugsFDA
Wedgewood Village Pharmacy, LLC recalls Estriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro
Hazard: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
July 13, 2022DrugsFDA
Wedgewood Village Pharmacy, LLC recalls Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewood Village Pharmacy LLC, 405 Heron Drive, S
Hazard: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
July 13, 2022DrugsFDA
Wedgewood Village Pharmacy, LLC recalls Boric Acid 600 mg capsules, 14 capsules per box, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swede
Hazard: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
July 13, 2022DrugsFDA
Wedgewood Village Pharmacy, LLC recalls Doxycycline (as Calcium) (equivalent to 50mg/5mL), 10 mg/ml, 60 ml suspension bottles, Peppermint, Qty: 1, Wedgewood Vil
Hazard: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection