March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham,
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham,
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham,
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b)
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,00
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,0
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-count bottle
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-c
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-c
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9; b) 100-co
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Accord Healthcare, Inc. recalls Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b) 100-
Hazard: CGMP Deviations: recalling drug products following an FDA inspection.
March 8, 2023DrugsFDA
Nephron Sc Inc recalls Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia,
Hazard: CGMP Deviations: Potential product carryover.
March 8, 2023DrugsFDA
SCA Pharmaceuticals recalls Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only,
Hazard: Subpotent Drug
March 8, 2023DrugsFDA
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle
Hazard: Lack of Assurance of Sterility
March 8, 2023DrugsFDA
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose V
Hazard: Lack of Assurance of Sterility
March 8, 2023DrugsFDA
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose V
Hazard: Lack of Assurance of Sterility
March 8, 2023DrugsFDA
Nephron Sterile Compounding Center LLC recalls Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single
Hazard: Lack of Assurance of Sterility
March 8, 2023DrugsFDA
Nephron Sterile Compounding Center LLC recalls Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Containe
Hazard: Lack of Assurance of Sterility
March 8, 2023DrugsFDA
Nephron Sterile Compounding Center LLC recalls Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container
Hazard: Lack of Assurance of Sterility
March 8, 2023DrugsFDA
Nephron Sterile Compounding Center LLC recalls Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container
Hazard: Lack of Assurance of Sterility
March 8, 2023DrugsFDA
Nephron Sterile Compounding Center LLC recalls Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged
Hazard: Lack of Assurance of Sterility
March 8, 2023DrugsFDA
Sciegen Pharmaceuticals Inc recalls Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge
Hazard: Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
March 8, 2023DrugsFDA
Alvogen, Inc recalls Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 5
Hazard: Sub-Potent Drug: Out of specification for assay at the 24 month interval.
March 8, 2023DrugsFDA
DuPont Nutrition USA, Inc recalls BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp., Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Man
Hazard: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
March 8, 2023DrugsFDA
DuPont Nutrition USA, Inc recalls Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk containe
Hazard: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
March 8, 2023DrugsFDA
DuPont Nutrition USA, Inc recalls Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk contain
Hazard: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.