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Drug recalls

Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.

17,975 records · source: openFDA Enforcement

All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
Most recent recall enforcement reports first.
Class Reported Product Reason Firm Status
Class II February 21, 2018 Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 2 Suction… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Short Term Oral Swab System with Perox-A-Mint Solution. Contains: 20… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Toothette Oral Care Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer.… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class II February 21, 2018 Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG)… Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment… Sage Products Inc Terminated
Class III February 21, 2018 NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count… Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the… ALLERGAN Terminated
Class III February 21, 2018 Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada,… Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product… Genentech, Inc. Terminated
Class III February 21, 2018 Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva… Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within… Teva Pharmaceuticals USA Terminated
Class II February 14, 2018 Relumins Vitamin C Solvent ampules Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products… Flawless Beauty LLC Terminated
Class II February 14, 2018 Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products… Flawless Beauty LLC Terminated
Class II February 14, 2018 VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, SUBCUTANEOUS… Defective Container: Confirmed reports of loose vial crimps. Millennium Pharmaceuticals Inc. Terminated
Class II February 14, 2018 Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile,… Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products… Flawless Beauty LLC Terminated
Class II February 14, 2018 All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF… Lack of sterility assurance. Intrathecal Compounding Specialist, LLC Terminated
Class II February 14, 2018 Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg glass vials,… Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products… Flawless Beauty LLC Terminated
Class II February 14, 2018 Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured in India Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products… Flawless Beauty LLC Terminated
Class III February 14, 2018 Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC… Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits Teva Pharmaceuticals USA Terminated
Class III February 14, 2018 Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC… Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits Teva Pharmaceuticals USA Terminated
Class II February 14, 2018 Reiki Glutathione Whitening kits Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products… Flawless Beauty LLC Terminated
Class III February 14, 2018 Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups),… Subpotent Drug: Out of specification for assay (stability testing) Mckesson Packaging Services Terminated
Class II February 14, 2018 All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate… Lack of sterility assurance. Intrathecal Compounding Specialist, LLC Terminated
Class II February 14, 2018 All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base… Lack of sterility assurance. Intrathecal Compounding Specialist, LLC Terminated
Class II February 14, 2018 Ling Zhi capsules Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products… Flawless Beauty LLC Terminated
Class II February 14, 2018 TP Drug Laboratories Vitamin C ampules Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products… Flawless Beauty LLC Terminated
Class III February 14, 2018 Ciclopirox Olamine Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30… Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow… G & W Laboratories, Inc. Terminated
Class III February 14, 2018 Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx… Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits Teva Pharmaceuticals USA Terminated
Class II February 14, 2018 Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products… Flawless Beauty LLC Terminated
Class II February 14, 2018 Aripiprazole Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber… CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications. Hetero Labs, Ltd. - Unit III Terminated
Class II February 14, 2018 Tatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products… Flawless Beauty LLC Terminated
Class III February 14, 2018 Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx… Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits Teva Pharmaceuticals USA Terminated
Class II February 14, 2018 All sterile drug preparations remaining within expiry prepared from Hydromorphone Base… Lack of sterility assurance. Intrathecal Compounding Specialist, LLC Terminated
Class II February 14, 2018 TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials, 10 vials +… Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products… Flawless Beauty LLC Terminated
Class II February 14, 2018 Laennec INJ, Placenta extract (human), 2mL vials, Manufactured by: GCJBP Corp, Korea Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products… Flawless Beauty LLC Terminated
Class I February 14, 2018 Ampicillin and Sulbactam Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10… Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate… Aurobindo Pharma Ltd. Terminated
Class II February 14, 2018 Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by:… Labeling: Label Error on Declared Strength Astellas Pharma US Inc Terminated
Class I February 14, 2018 Pantoprazole Sodium Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only,… Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of… AuroMedics Pharma LLC Terminated
Class I February 14, 2018 Linezolid Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible… Presence of Particulate Matter; white particulate matter identified as mold was found in one bag AuroMedics Pharma LLC Terminated
Class II February 7, 2018 Medline Vitrectomy CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries,… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline RAD NECK ENT TRAY Pack, Single Use Only. Packaged in USA for Medline Industries,… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline TRAY, CATHETER CARE, LIDDED. Packaged in USA for Medline Industries, Inc.,… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline DC Line Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries,… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Circumcision Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline CC Drawer 4 IV Circulation Pack, Contains Rx, Single Use Only, contains 2 Prep… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Staple Remover Kit, Sterile, Single Use Only. Packaged in USA for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Neutrogena Acne Proofing whipped foam cleanser, (Salicylic Acid 2%), aerosolized product… Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup… Johnson & Johnson Terminated
Class I February 7, 2018 Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class II February 7, 2018 Tiger King tablets, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class II February 7, 2018 Neutrogena deep clean purifying whipped foam cleanser, (Salicylic Acid 0.5%), aerosolized… Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup… Johnson & Johnson Terminated
Class I February 7, 2018 GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class II February 7, 2018 Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark… CGMP Deviations: Market complaints related to "gritty texture". Glenmark Pharmaceuticals Inc., USA Terminated
Class III February 7, 2018 Indian God Lotion Spray Bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive… A&H Focal Inc. Terminated
Class II February 7, 2018 Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by:… Labeling: Label Error on Declared Strength Premier Pharmacy Labs Inc Terminated
Class I February 7, 2018 GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class I February 7, 2018 Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class I February 7, 2018 BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC… Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA… Blue Fusion Natural Terminated
Class I February 7, 2018 HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class I February 7, 2018 LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign… Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class I February 7, 2018 MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class II February 7, 2018 Neutrogena Elevated 4-Holiday Trays (contains Neutrogena Deep Clean Purifying Whipped… Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup… Johnson & Johnson Terminated
Class II February 7, 2018 Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class III February 7, 2018 Atorvastatin Calcium Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd… Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities… Dr. Reddy's Laboratories, Inc. Terminated
Class I February 7, 2018 Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International… LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg. International Laboratories, LLC Terminated
Class II February 7, 2018 PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC… CGMP deviations. PD-Rx Pharmaceuticals, Inc. Terminated
Class I February 7, 2018 YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class I February 7, 2018 ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign… Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class II February 7, 2018 STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class I February 7, 2018 DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in foreign… Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class II February 7, 2018 Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class I February 7, 2018 Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class III February 7, 2018 Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This… Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date. JCB Laboratories LLC Terminated
Class I February 7, 2018 GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class II February 7, 2018 MAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class II February 7, 2018 HARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class I February 7, 2018 LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class I February 7, 2018 Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for… A&H Focal Inc. Terminated
Class III February 7, 2018 Atorvastatin Calcium Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd… Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities… Dr. Reddy's Laboratories, Inc. Terminated
Class III February 7, 2018 Atorvastatin Calcium Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's… Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities… Dr. Reddy's Laboratories, Inc. Terminated
Class II February 7, 2018 Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient:… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline INCISION AND DRAINAGE TRAY Kit, Sterile, Single use only. Packaged in Mexico for… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medical Equipment Affiliates IV Start Kit, Sterile, Single Use Only. Packaged in Mexico… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Central Line Dressing Change Tray Kit, Sterile, Single use only. Packaged in… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Incision Drainage Tray, Sterile, Single Use Only. Packaged in Mexico for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Concordia Trunk Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093 Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Wound Closure Tray, Sterile, Single use only. Packaged in Mexico for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Skin Stapler RMVR, Tray Sterile, Single Use Only. Packaged in Mexico for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Pacemaker Implant Pack, Sterile, Single Use Only. Packaged in Mexico by Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Irrigation W/Piston SYR Tray, Sterile, Single Use Only. Packaged in Mexico for… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Hip Replacement, Kit, Sterile, Single Use Only. Packaged in Mexico by Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Suture Removal Pack Latex Safe, Sterile, Single Use Only. Packaged in Mexico for… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline General Purpose Kit, Sterile, Single use only. Packaged in Mexico for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline CNTRL Line Removal Kit Scripps. Packaged in USA for Medline Industries, Inc.,… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Vaginal Delivery CDS Pack, Single Use Only. Packaged in Mexico for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline GHS Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Incision Drainage Kit, Sterile, Single Use Only. Packaged in Mexico by Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Newborn Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093 Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Debridement Tray, Sterile, Single Use Only. Assembled in USA by Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Concordia Nurse Bag Kit. Packaged in USA for Medline Industries, Inc.,… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline IV Start Kit, Sterile, Single use only. Packaged in Mexico for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Anesthesia Kit, Single Use Only. Packaged in Mexico by Medline Industries, Inc.,… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Catheter Insertion Kit, Sterile. Packaged in Mexico for Medline Industries, Inc.,… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Staple Remover Tray, Sterile, Single Use Only. Packaged in USA for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Abdominal Surgery II Pack-LF, Sterile, Single Use Only. Packaged in USA for… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Skin Staple Remover Kit, Sterile, Single Use Only. Packaged in Mexico for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Incision and Drainage Tray Kit, Sterile, Single use only. Packaged in USA for… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Trunk Kit, Non-sterile. Packaged in USA for Medline Industries, Inc., Mundelein,… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Sheath Removal Kit, Sterile, Single use only. Packaged in Mexico for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Laceration Tray, Sterile, Single Use Only. Packaged in USA for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Skin Biopsy Pack-LF, Sterile, Single Use Only. Packaged in USA by Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline NICC Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline General Purpose Instrument Set, Sterile, Single Use Only. Packaged in Mexico for… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Pediatric IV Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline I&D Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Incision & Drainage Tray, Sterile, Single Use Only. Packaged in USA for Medline… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline Straight Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Liberator Medical Supply Catheter Insertion Tray, Sterile, Single Use Only. Distributed… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class II February 7, 2018 Medline All Purpose Instrument Tray, Sterile. Packaged in Mexico for Medline Industries,… Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%. Medline Industries Inc Terminated
Class III February 7, 2018 Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie… Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility… AbbVie Inc. Terminated
Class II February 7, 2018 Spiriva SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules… Failed Stability Specifications Boehringer Ingelheim Pharmaceuticals, Inc. Terminated
Class III February 7, 2018 Oxycodone Hydrochloride Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for… Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol Ascent Pharmaceuticals, Inc. Terminated
Class III February 7, 2018 Clobetasol Propionate Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical… Failed Content Uniformity Specifications Taro Pharmaceuticals U.S.A., Inc. Terminated
Class I February 7, 2018 Nexterone Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile,… Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports… Baxter Healthcare Corporation Terminated
Class III February 7, 2018 Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake… Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12… Fresenius Kabi USA, LLC Terminated
Class II January 31, 2018 Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to… Marksans Pharma Inc. Terminated
Class II January 31, 2018 Ibuprofen Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to… Marksans Pharma Inc. Terminated
Class II January 31, 2018 Ibuprofen Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to… Marksans Pharma Inc. Terminated
Class III January 31, 2018 bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only,… Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to… Mylan Pharmaceuticals Inc. Terminated
Class I January 31, 2018 BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle,… Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine. BotanicalNow Terminated
Class I January 31, 2018 MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL… Subpotent Advanced Pharma Inc. Terminated
Class I January 31, 2018 Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one… Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil. www.blankterrmall.com Terminated
Class II January 31, 2018 Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxybenzone 5%} 15… Failed Stability Specifications:stability failure at 12 months, long term RT conditions. Odan Laboratories Ltd Terminated
Class II January 31, 2018 Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 tablets for… Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same… International Laboratories, Inc. Terminated
Class II January 31, 2018 Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe and Almond… Microbial Contamination of Non-Sterile Products. DLC Laboratories, Inc Terminated
Class II January 31, 2018 Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for… Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same… International Laboratories, Inc. Terminated
Class II January 31, 2018 Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. Kit… Failed Stability Specifications:stability failure at 12 months, long term RT conditions. Odan Laboratories Ltd Terminated
Class II January 31, 2018 Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to… Marksans Pharma Inc. Terminated
Class II January 31, 2018 Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to… Marksans Pharma Inc. Terminated
Class II January 31, 2018 Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper… CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to… Marksans Pharma Inc. Terminated
Class II January 31, 2018 Doxorubicin Hydrochloride DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use… Lack Of Assurance Of Sterility Sun Pharmaceutical Industries, Inc. Terminated
Class II January 24, 2018 Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473… Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination Pharmatech LLC Terminated
Class II January 24, 2018 Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate… GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. SHISEIDO AMERICA INC. Terminated
Class II January 24, 2018 Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic… Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination Pharmatech LLC Terminated
Class II January 24, 2018 Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473… Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination Pharmatech LLC Terminated
Class II January 24, 2018 Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured… Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing. AVKARE Inc. Terminated
Class II January 24, 2018 bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide… GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. SHISEIDO AMERICA INC. Terminated
Class III January 24, 2018 Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco… Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine… Shionogi Inc. Terminated
Class II January 24, 2018 Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL)… Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination Pharmatech LLC Terminated
Class II January 24, 2018 ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total… Subpotent Drug Pharmedium Services, LLC Terminated
Class III January 24, 2018 Simvastatin Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber… Presence of foreign substance: metallic razor blade was found in one bottle. Hetero Labs, Ltd. - Unit III Terminated
Class II January 24, 2018 Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%,… GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. SHISEIDO AMERICA INC. Terminated
Class II January 24, 2018 Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe… GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. SHISEIDO AMERICA INC. Terminated
Class II January 24, 2018 Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%,… GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. SHISEIDO AMERICA INC. Terminated
Class II January 24, 2018 Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes,… Superpotent Drug Pharmedium Services, LLC Terminated
Class II January 24, 2018 Divalproex Sodium Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only,… Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium. Unichem Pharmaceuticals Usa Inc Terminated
Class II January 17, 2018 Sermorelin, 3 mg/ GHRP6, 1.8 mg/ GHRP2, 1.8 mg/mL in 3 mL Cartridge, For SC Use, Rx Only,… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total… Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date. SCA Pharmaceuticals Terminated
Class II January 17, 2018 Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units… Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Terminated
Class II January 17, 2018 Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology, 791… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 QUADMIX #18, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd,… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Chloramphenicol 500 mg Sulfamethoxazole 500 mg Amphotericin 50 mg Otic Powder packaged in… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnology, 791… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, Rx Only, KRS Global… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 2.5%/ 1%/ 0.5%… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Trimix #22F (Prostaglandin E1 25 mcg/ Papaverine HCl 30 mg/ Phentolamine Mesylate 2… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Only, KRS… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Estriol 0.1% (1 mg/gm) Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd,… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Chloramphenicol 50 mg/ Sulfamethoxazole 50 mg/ Amphotericin-B 5 mg capsules, For OTIC Use… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Bi-Est (Estriol/Estradiol) (80/20) + Progesterone 7.5 mg/200 mg Cream packaged in jars,… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 units per… Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Terminated
Class II January 17, 2018 Iodochlorhydroxyquin 3%/ Boric Acid 10%/ Amphotericin 5% Otic Powder packaged in jars, Rx… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 units… Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Terminated
Class II January 17, 2018 Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units… Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Terminated
Class II January 17, 2018 Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Biotechnology,… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, Rx Only, KRS Global… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Vitamin 9 A/B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class III January 17, 2018 Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx… CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer. Akorn Inc Terminated
Class II January 17, 2018 PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd,… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use, Rx Only, KRS Global… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Global… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Savinase 100 mcg/mL Topical Solution, 1 mL in a 3 mL Droptainer, Rx Only, KRS Global… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Human Chorionic Gonadotropin 2,500 Units, Vial-Lyophilized, For SC Use, Rx Only, KRS… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Nicotinamide Adenine Dinucleotide 500 mg packaged in vials, Lyophilized-For IV Use, Rx… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Vitamin 9 Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology, 791 Park of… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg… Microbial Contamination of Non-Sterile Products Pfizer Manufacturing Deutschland GmbH Terminated
Class II January 17, 2018 Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed… Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the… ALLERGAN Terminated
Class II January 17, 2018 Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx Only, KRS… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 QUADMIX #16, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd,… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Methylene Blue (PF) 10 mg/mL (1%) Injectable Vial, Rx Only, KRS Global Biotechnology, 791… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Anastrozole 0.5 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of Commerce… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged in jars, Rx… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count… Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine… Teva Pharmaceuticals USA Terminated
Class II January 17, 2018 Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193,… Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg Solco Healtcare US LLC Terminated
Class II January 17, 2018 Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx Only, KRS… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, Rx Only, KRS… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Hydroquinone 8%/ Tretinoin 0.1% Topical Ointment packaged in jars, Rx Only, KRS Global… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx Only, KRS… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Progesterone 3% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Liothyronine SR (T3) 20 mcg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 QUADMIX #17, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd,… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 mL Vial, Rx Only, KRS Global… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Cyclopentolate HCl/ Phenylephrine HCl/ Tropicamide/ Ketorolac 1%/ 10%/ 1%/ 0.5%… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Oxytocin 30 Units in 0.9% Sodium Chloride Solution (PF) IV Bag, For IV Infusion Use, Rx… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder packaged in… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mesylate 0.6… Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient… KRS Global Biotechnology, Inc Terminated
Class II January 17, 2018 Docetaxel Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's… Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the… Dr. Reddy's Laboratories, Inc. Terminated
Class II January 17, 2018 Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. ,… Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia Woodfield Pharmaceutical, LLC Terminated
Class II January 17, 2018 Valsartan Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang… Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle. Prinston Pharmaceutical Inc Terminated
Class III January 17, 2018 Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx… Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister… Sanofi-Aventis U.S. LLC Terminated
Class I January 10, 2018 Midazolam Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled… Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of… Fresenius Kabi USA, LLC Terminated
Class I January 10, 2018 Enhanced Vegetal Vigra 200 mg Capsules, 8 count bottles, Manufacturer: Hand-shaking… Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil. Natures Supplement Terminated
Class II January 10, 2018 Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig… SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent Pfizer Inc. Terminated
Class I January 10, 2018 diphenoxylate hydrochloride and atropine sulfate diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a)… SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent Pfizer Inc. Terminated
Class III January 3, 2018 morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg… Labeling: Incorrect or Missing Lot and/or Exp. Date Pharmedium Services, LLC Terminated
Class II January 3, 2018 Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100… Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No… SSM Health Care St. Louis DBA SSM St. Clare Health Center Terminated
Class II January 3, 2018 Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a… Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No… SSM Health Care St. Louis DBA SSM St. Clare Health Center Terminated
Class III January 3, 2018 Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain,… Failed Stability Specifications Bayer HealthCare Pharmaceuticals, Inc. Terminated
Class III January 3, 2018 morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL , For IV… Labeling: Incorrect or Missing Lot and/or Exp. Date Pharmedium Services, LLC Terminated
Class II January 3, 2018 Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile,… Lack of Assurance of Sterility and cGMP Deviations Simple Diagnostics, Inc. Terminated
Class II January 3, 2018 Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. This is a… Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No… SSM Health Care St. Louis DBA SSM St. Clare Health Center Terminated
Class III January 3, 2018 HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For… Labeling: Incorrect or Missing Lot and/or Exp. Date Pharmedium Services, LLC Terminated
Class II January 3, 2018 Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This… Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No… SSM Health Care St. Louis DBA SSM St. Clare Health Center Terminated
Class II January 3, 2018 HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration:… Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No… SSM Health Care St. Louis DBA SSM St. Clare Health Center Terminated
Class II January 3, 2018 Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This… Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No… SSM Health Care St. Louis DBA SSM St. Clare Health Center Terminated