November 1, 2023DrugsFDA
Biomic Sciences, LLC dba ION Intelligence of Nature recalls Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA
Hazard: Microbial contamination of Non-Sterile Products
November 1, 2023DrugsFDA
Biomic Sciences, LLC dba ION Intelligence of Nature recalls ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA
Hazard: Microbial contamination of Non-Sterile Products
November 1, 2023DrugsFDA
Biomic Sciences, LLC dba ION Intelligence of Nature recalls ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA
Hazard: Microbial contamination of Non-Sterile Products
November 1, 2023DrugsFDA
West-Ward Columbus Inc recalls Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceutical
Hazard: Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
October 25, 2023DrugsFDA
Pine Pharmaceuticals, LLC recalls Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounde
Hazard: Lack of Assurance of Sterility
October 25, 2023DrugsFDA
Pine Pharmaceuticals, LLC recalls Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded
Hazard: Lack of Assurance of Sterility
October 25, 2023DrugsFDA
Pine Pharmaceuticals, LLC recalls Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine
Hazard: Lack of Assurance of Sterility
October 25, 2023DrugsFDA
Pine Pharmaceuticals, LLC recalls Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk
Hazard: Lack of Assurance of Sterility
October 25, 2023DrugsFDA
Pine Pharmaceuticals, LLC recalls Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals
Hazard: Lack of Assurance of Sterility
October 25, 2023DrugsFDA
Pine Pharmaceuticals, LLC recalls TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compou
Hazard: Lack of Assurance of Sterility
October 25, 2023DrugsFDA
Pine Pharmaceuticals, LLC recalls Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway,
Hazard: Lack of Assurance of Sterility
October 25, 2023DrugsFDA
Pine Pharmaceuticals, LLC recalls Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharm
Hazard: Lack of Assurance of Sterility
October 25, 2023DrugsFDA
Pine Pharmaceuticals, LLC recalls Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tona
Hazard: Lack of Assurance of Sterility
October 25, 2023DrugsFDA
Pine Pharmaceuticals, LLC recalls Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx on
Hazard: Lack of Assurance of Sterility
October 25, 2023DrugsFDA
Pine Pharmaceuticals, LLC recalls Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by
Hazard: Lack of Assurance of Sterility
October 25, 2023DrugsFDA
Pine Pharmaceuticals, LLC recalls Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355
Hazard: Lack of Assurance of Sterility
October 25, 2023DrugsFDA
Pine Pharmaceuticals, LLC recalls Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 River
Hazard: Lack of Assurance of Sterility
October 25, 2023DrugsFDA
Pine Pharmaceuticals, LLC recalls Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverw
Hazard: Lack of Assurance of Sterility
October 25, 2023DrugsFDA
Pine Pharmaceuticals, LLC recalls Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmac
Hazard: Lack of Assurance of Sterility
October 25, 2023DrugsFDA
Pine Pharmaceuticals, LLC recalls Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 River
Hazard: Lack of Assurance of Sterility
October 25, 2023DrugsFDA
KVK-Tech, Inc. recalls Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech Inc., Newtown, PA 18940, Made in USA, NDC# 10
Hazard: Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
October 25, 2023DrugsFDA
Baxter Healthcare Corporation recalls Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured f
Hazard: CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
October 25, 2023DrugsFDA
VistaPharm LLC recalls Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Dist
Hazard: Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
October 25, 2023DrugsFDA
Church & Dwight Inc recalls TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry
Hazard: Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis
October 25, 2023DrugsFDA
Dollar Tree Distribution, Inc. recalls Certain Over-The-Counter (OTC) drug products sold by Family Dollar retail stores.
Hazard: CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
October 25, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharm
Hazard: Failed Dissolution Specifications
October 25, 2023DrugsFDA
Imprimis NJOF, LLC recalls MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution Drops 1% - 0.5% - 2.5% -
Hazard: Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
October 18, 2023DrugsFDA
Scynexis, Inc. recalls BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc.,
Hazard: Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).
October 11, 2023DrugsFDA
Eugia US LLC recalls Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL Multiple Dose Vial, Rx Only, For I
Hazard: Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
October 11, 2023DrugsFDA
Imprimis NJOF, LLC recalls Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-
Hazard: Subpotent: Failing Test Results for Epinephrine