January 25, 2023DrugsFDA
Akorn, Inc. recalls Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactu
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., L
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 600
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc.
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by:
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufa
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn,
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Akorn, Inc. recalls AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Steri
Hazard: CGMP Deviations:
January 25, 2023DrugsFDA
Accord Healthcare, Inc. recalls Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC
Hazard: Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
January 25, 2023DrugsFDA
Fresenius Kabi USA, LLC recalls Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 m
Hazard: Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
January 25, 2023DrugsFDA
Fresenius Kabi USA, LLC recalls Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg pe
Hazard: Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
January 25, 2023DrugsFDA
Fresenius Kabi USA, LLC recalls Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg p
Hazard: Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE, packaged in 2.5 mL Multiple-D
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compou
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-D
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials,
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vial
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 2.5 mL Multi
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharm
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multip
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials,
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, R
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, R
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, R
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 234
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 234
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23
Hazard: Lack of Assurance of Sterility
January 18, 2023DrugsFDA
Northern VA Compounders PLLC recalls Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina
Hazard: Lack of Assurance of Sterility