March 20, 2024DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-
Hazard: cGMP Deviations: Products were stored outside the drug label specifications.
March 20, 2024DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma L
Hazard: cGMP Deviations: Products were stored outside the drug label specifications.
March 20, 2024DrugsFDA
B. Braun Medical Inc recalls Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc.,
Hazard: Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
March 20, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
March 20, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38
Hazard: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
March 13, 2024DrugsFDA
Stason Pharmaceuticals, Inc. recalls Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-91
Hazard: Failed Dissolution Specifications: results slightly under spec at at 9-months.
March 13, 2024DrugsFDA
Eugia US LLC recalls Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in
Hazard: Failed Dissolution Specifications
March 13, 2024DrugsFDA
Contract Pharmaceuticals Limited Canada recalls Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canad
Hazard: Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
March 13, 2024DrugsFDA
Contract Pharmaceuticals Limited Canada recalls Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuti
Hazard: Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
March 6, 2024DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compa
Hazard: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
March 6, 2024DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-09
Hazard: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
March 6, 2024DrugsFDA
Denver Solutions, LLC DBA Leiters Health recalls Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose
Hazard: Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
March 6, 2024DrugsFDA
Seatex LLC recalls PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases
Hazard: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
March 6, 2024DrugsFDA
Seatex LLC recalls 7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Driv
Hazard: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
March 6, 2024DrugsFDA
Seatex LLC recalls 7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Dis
Hazard: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
March 6, 2024DrugsFDA
Seatex LLC recalls PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, T
Hazard: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
March 6, 2024DrugsFDA
Seatex LLC recalls PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacter
Hazard: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
March 6, 2024DrugsFDA
Bausch Health Companies, Inc. recalls Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg
Hazard: Subpotent Drug: Out of specification for assay
March 6, 2024DrugsFDA
Brassica Pharma Pvt Ltd recalls Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE P
Hazard: Lack of Assurance of Sterility
March 6, 2024DrugsFDA
Brassica Pharma Pvt Ltd recalls CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 g
Hazard: Lack of Assurance of Sterility
March 6, 2024DrugsFDA
Brassica Pharma Pvt Ltd recalls Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by
Hazard: Lack of Assurance of Sterility
March 6, 2024DrugsFDA
Brassica Pharma Pvt Ltd recalls Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Wa
Hazard: Lack of Assurance of Sterility
March 6, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical I
Hazard: Failed Dissolution Specifications: Out of specification for dissolution.
March 6, 2024DrugsFDA
Golden State Medical Supply Inc. recalls Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: A
Hazard: CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
February 28, 2024DrugsFDA
Micro Labs Limited recalls Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured f
Hazard: CGMP Deviations: Out of specification for residual solvents.
February 28, 2024DrugsFDA
MCKESSON CORPORATION recalls CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or
Hazard: CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
February 28, 2024DrugsFDA
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company recalls TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Ph
Hazard: Chemical Contamination; presence of benzene.
February 28, 2024DrugsFDA
Today The World recalls Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne
Hazard: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
February 28, 2024DrugsFDA
Today The World recalls SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA
Hazard: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
February 28, 2024DrugsFDA
Today The World recalls Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Neva
Hazard: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.