February 7, 2018DrugsFDA
Medline Industries Inc recalls Medline Central Line Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc.
Hazard: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
February 7, 2018DrugsFDA
Medline Industries Inc recalls Medline IV Start Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Hazard: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
February 7, 2018DrugsFDA
Medline Industries Inc recalls Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL
Hazard: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
February 7, 2018DrugsFDA
Medline Industries Inc recalls Medline TRAY, CATHETER CARE, LIDDED. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Hazard: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
February 7, 2018DrugsFDA
Medline Industries Inc recalls Medline Trunk Kit, Non-sterile. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Hazard: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
February 7, 2018DrugsFDA
Medline Industries Inc recalls Medline CNTRL Line Removal Kit Scripps. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Hazard: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
February 7, 2018DrugsFDA
Medline Industries Inc recalls Medline Pediatric IV Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Hazard: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
February 7, 2018DrugsFDA
Medline Industries Inc recalls Medline Concordia Nurse Bag Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Hazard: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
February 7, 2018DrugsFDA
Medline Industries Inc recalls Medline Concordia Trunk Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093
Hazard: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
February 7, 2018DrugsFDA
Medline Industries Inc recalls Medline Newborn Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093
Hazard: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
February 7, 2018DrugsFDA
Medline Industries Inc recalls Medline RAD NECK ENT TRAY Pack, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Hazard: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
February 7, 2018DrugsFDA
Medline Industries Inc recalls Medline Vitrectomy CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Hazard: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
February 7, 2018DrugsFDA
Medline Industries Inc recalls Medline Vaginal Delivery CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 6009
Hazard: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
February 7, 2018DrugsFDA
Medline Industries Inc recalls Medline CC Drawer 4 IV Circulation Pack, Contains Rx, Single Use Only, contains 2 Prep Pad PVPs. Packaged in USA for Med
Hazard: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
February 7, 2018DrugsFDA
Medline Industries Inc recalls Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, I
Hazard: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
February 7, 2018DrugsFDA
Premier Pharmacy Labs Inc recalls Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial
Hazard: Labeling: Label Error on Declared Strength
February 7, 2018DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Isra
Hazard: Failed Content Uniformity Specifications
February 7, 2018DrugsFDA
Ascent Pharmaceuticals, Inc. recalls Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., P
Hazard: Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
February 7, 2018DrugsFDA
Blue Fusion Natural recalls BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
Hazard: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
February 7, 2018DrugsFDA
JCB Laboratories LLC recalls Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital
Hazard: Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
February 7, 2018DrugsFDA
Johnson & Johnson recalls Neutrogena Elevated 4-Holiday Trays (contains Neutrogena Deep Clean Purifying Whipped Foam Cleanser) Case Code: 000705
Hazard: Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
February 7, 2018DrugsFDA
Johnson & Johnson recalls Neutrogena deep clean purifying whipped foam cleanser, (Salicylic Acid 0.5%), aerosolized product in a can, NET WT. 5 OZ
Hazard: Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
February 7, 2018DrugsFDA
Johnson & Johnson recalls Neutrogena Acne Proofing whipped foam cleanser, (Salicylic Acid 2%), aerosolized product in a can, NET WT. 5 OZ (141 g)
Hazard: Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
February 7, 2018DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx
Hazard: Failed Stability Specifications
January 31, 2018DrugsFDA
Advanced Pharma Inc. recalls MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx on
Hazard: Subpotent
January 31, 2018DrugsFDA
BotanicalNow recalls BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481
Hazard: Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.
January 31, 2018DrugsFDA
www.blankterrmall.com recalls Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesP
Hazard: Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.
January 31, 2018DrugsFDA
DLC Laboratories, Inc recalls Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe and Almond Oil, 8 fl. oz. (237 mL) HPDE bott
Hazard: Microbial Contamination of Non-Sterile Products.
January 31, 2018DrugsFDA
Marksans Pharma Inc. recalls Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx on
Hazard: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
January 31, 2018DrugsFDA
Marksans Pharma Inc. recalls Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx on
Hazard: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.