February 7, 2024DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Com
Hazard: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
February 7, 2024DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Comp
Hazard: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
February 7, 2024DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 1379
Hazard: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
February 7, 2024DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 1379
Hazard: Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
February 7, 2024DrugsFDA
Golden State Medical Supply Inc. recalls Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UP
Hazard: Failed Dissolution Specifications
February 7, 2024DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort
Hazard: Failed Dissolution Specifications
February 7, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore,
Hazard: Failed Impurities/Degradation Specifications
January 31, 2024DrugsFDA
Haleon US Holdings LLC recalls Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distr
Hazard: Microbial Contamination of Non-Sterile Products
January 31, 2024DrugsFDA
Haleon US Holdings LLC recalls Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8
Hazard: Microbial Contamination of Non-Sterile Products
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceuti
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceut
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industrie
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industri
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: S
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries,
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, I
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury,
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
January 31, 2024DrugsFDA
BE PHARMACEUTICALS AG recalls Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution an
Hazard: Lack of Sterility Assurance: Aseptic process simulation failure.
January 31, 2024DrugsFDA
PFIZER recalls Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc
Hazard: Presence of particulate matter: glass
January 31, 2024DrugsFDA
Strides Pharma Inc. recalls Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 56210
Hazard: Failed Dissolution Specifications
January 31, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Gl
Hazard: Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
January 31, 2024DrugsFDA
IntegraDose Compounding Services LLC recalls Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 7113
Hazard: Subpotent Drug
January 31, 2024DrugsFDA
Amerisource Health Services LLC recalls Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American He
Hazard: Superpotent drug: Assay results were slightly above specification at the time zero point.
January 24, 2024DrugsFDA
The Procter & Gamble Company recalls Secret Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topical spray can Net Wt 3.8 oz (107 g), Dist. by:
Hazard: CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
January 24, 2024DrugsFDA
The Procter & Gamble Company recalls Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Lavender, Topical spray can Net Wt 3.8 oz (107 g), Di
Hazard: CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
January 24, 2024DrugsFDA
The Procter & Gamble Company recalls Secret, Dry Spray, Aluminum chlorohydrate 23.5% Antiperspirant, Waterlily, Topical Spray Can, Net Wt 3.8 oz (107 g), Dis
Hazard: CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
January 24, 2024DrugsFDA
The Procter & Gamble Company recalls Secret, powder fresh, (Aluminum chlorohydrate 24%), Anti-Perspirant/Deodorant, Topical spray can Net Wt., (a) 4OZ (113g)
Hazard: CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene