February 7, 2018DrugsFDA
Fresenius Kabi USA, LLC recalls Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India,
Hazard: Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
February 7, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA
Hazard: Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
February 7, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd
Hazard: Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
February 7, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd
Hazard: Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
February 7, 2018DrugsFDA
AbbVie Inc. recalls Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, US
Hazard: Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
February 7, 2018DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-
Hazard: CGMP deviations.
February 7, 2018DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manuf
Hazard: CGMP Deviations: Market complaints related to "gritty texture".
February 7, 2018DrugsFDA
Medline Industries Inc recalls Medline Incision & Drainage Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, 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 Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 6006
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 USA for Medline Industries, Inc., Mundelein, IL 6006
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 Abdominal Surgery II Pack-LF, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield
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 Incision Drainage 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 Skin Stapler RMVR, Tray Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, I
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 Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital
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 Pack Latex Safe, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., North
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 Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital
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 by Medline Industries, Inc., Mundelein, IL 600
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 by Medline Industries, Inc., Mundelein, IL 600
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 Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein,
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 by Medline Industries, Inc., Mundelein, IL 600
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 Anesthesia Kit, Single Use Only. Packaged in Mexico by 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 Incision Drainage Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 6
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 Hip Replacement, Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 6
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 Pacemaker Implant Pack, Sterile, Single Use Only. Packaged in Mexico by 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 Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein,
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 Skin Biopsy Pack-LF, Sterile, Single Use Only. Packaged in USA by 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 Debridement Tray, Sterile, Single Use Only. Assembled in USA by Medline Industries, Inc., Mundelein, IL 6060
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 Medical Equipment Affiliates IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medical Equipment Affiliates
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., 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 Irrigation W/Piston SYR Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfi
Hazard: Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.