March 15, 2023DrugsFDA
Nutraceutical Corporation recalls NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questi
Hazard: CGMP Deviations: Raw material recalled by repackager, due to discoloration.
March 15, 2023DrugsFDA
Nutraceutical Corporation recalls NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd. Nutraceutical Corp.,
Hazard: CGMP Deviations: Raw material recalled by repackager, due to discoloration.
March 15, 2023DrugsFDA
Amerisource Health Services LLC recalls Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by
Hazard: Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
March 15, 2023DrugsFDA
Sagent Pharmaceuticals Inc recalls Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutan
Hazard: Labeling: Not elsewhere classified
March 15, 2023DrugsFDA
B. Braun Medical Inc recalls Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.B
Hazard: Subpotent Drug: low Anti-Factor IIa potency.
March 15, 2023DrugsFDA
Apotex Corp. recalls Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60
Hazard: Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
March 8, 2023DrugsFDA
Volt Candy Wholesale Club recalls PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Pr
Hazard: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
March 8, 2023DrugsFDA
The Harvard Drug Group recalls Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Te
Hazard: Packaging defect: observed packaging defect, blister packaging inadequately sealed.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manu
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manu
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Man
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Ma
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Man
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 M
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufa
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 277
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-c
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-co
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-coun
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-c
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Man
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-c
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; b) 1,000-c
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.