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High RiskFDA
Teligent Pharma, Inc.
Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15; b) Net Wt. 30 grams tubes, NDC 52565-122-30; c) 5 x 5 gram ...
Topical Drugs·136,960 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC...
Topical Drugs·16,643 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; b) 30 grams tube, NDC 52565-094-30; c...
Topical Drugs·105,200 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-0...
Drugs·112,769 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, N...
Topical Drugs·48,907 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured by: Teligent Pharm, Inc., Buena, New Jersey 08310, ND...
Topical Drugs·4,532 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distribu...
Topical Drugs·21,323 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-08...
Drugs·30,497 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Desoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-045-99; b) 60 grams tubes, NDC 52565-045-60, Rx only, Manuf...
Topical Drugs·54,897 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15; b) 30 grams tubes, NDC 52565-042-30;...
Topical Drugs·217,184 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC ...
Topical Drugs·6,850 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-15...
Drugs·6,431 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge, LA 70809;...
Topical Drugs·26,326 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-039-30; c) 45 gram...
Topical Drugs·72,826 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, NDC 52565-082-30; c) 60 grams tube, N...
Topical Drugs·81,883 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bottles, NDC 52565...
Drugs·35,180 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams)...
Drugs·43,218 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Roug...
Topical Drugs·36,018 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11.
Topical Drugs·13,905 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA 70809,...
Topical Drugs·24,304 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-3...
Topical Drugs·51,748 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-025-59, Rx only, Te...
Topical Drugs·7,169 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30 grams tubes, NDC...
Topical Drugs·151,975 affected·Mar 15, 2022
High RiskFDA
Teligent Pharma, Inc.
Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA Pharmaceuticals, LLC, Baton Rouge, LA 708...
Topical Drugs·31,489 affected·Mar 15, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
Surgical Devices·486,578 affected·Mar 15, 2022
High RiskFDA
Baxter Healthcare Corporation
PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
Medical Devices·3,513 affected·Mar 15, 2022
High RiskFDA
Baxter Healthcare Corporation
PrisMax System, Product Code 955724
Medical Devices·296 affected·Mar 15, 2022
High RiskFDA
Graphic Controls Acquisition Corporation
CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
Medical Devices·560 affected·Mar 15, 2022
High RiskFDA
Vitae Enim Vitae Scientific, Inc.
TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pha...
Injectable Drugs·722 affected·Mar 14, 2022
High RiskFDA
Athenex Pharma Solutions, Llc
Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, N...
Injectable Drugs·0 affected·Mar 14, 2022
High RiskFDA
Athenex Pharma Solutions, Llc
Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, L...
Injectable Drugs·9,800 affected·Mar 14, 2022
High RiskFDA
Athenex Pharma Solutions, Llc
Norepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chloride, 16 mg, 250 mL excel bag, Rx only, Athenex Pharma Solu...
Injectable Drugs·5,320 affected·Mar 14, 2022
High RiskFDA
Vitae Enim Vitae Scientific, Inc.
PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL Vials per box (ND...
Injectable Drugs·21,501 affected·Mar 14, 2022
High RiskFDA
Vitae Enim Vitae Scientific, Inc.
PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL Vials per box (N...
Injectable Drugs·18,531 affected·Mar 14, 2022
High RiskFDA
Athenex Pharma Solutions, Llc
Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031...
Injectable Drugs·1,980 affected·Mar 14, 2022
High RiskFDA
Athenex Pharma Solutions, Llc
Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Cl...
Injectable Drugs·1,800 affected·Mar 14, 2022
High RiskFDA
Athenex Pharma Solutions, Llc
Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Cl...
Injectable Drugs·670 affected·Mar 14, 2022
High RiskFDA
Vitae Enim Vitae Scientific, Inc.
PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b)...
Injectable Drugs·2,098 affected·Mar 14, 2022
High RiskFDA
Athenex Pharma Solutions, Llc
Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LL...
Injectable Drugs·4,270 affected·Mar 14, 2022
High RiskFDA
Augustine Temperature Management, Llc
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; ...
Surgical Devices·1,113 affected·Mar 14, 2022
High RiskFDA
Augustine Temperature Management, Llc
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model #...
Surgical Devices·17 affected·Mar 14, 2022
High RiskFDA
Augustine Temperature Management, Llc
Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
Medical Devices·77 affected·Mar 14, 2022
CriticalFDA
Sensory Medical Inc
Cub 2 Enclosed Bed Canopy System
Medical Devices·225 affected·Mar 14, 2022
High RiskFDA
Augustine Temperature Management, Llc
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model #...
Surgical Devices·817 affected·Mar 14, 2022
CriticalFDA
Cavendish Farms
Les Fermes Cavendish Farms Frozen Original Hash Brown Potato Patties Net Wt, 42.3 (1.2 kg). 12 retail packages per case, 20 patties per r...
Frozen Food·441 affected·Mar 13, 2022
High RiskFDA
Dash Pharmaceuticals Llc
Sucralfate Oral Suspension, USP 1g/10mL, packaged in a) 40 case of 10 mL unit Dose Cups (NDC 69339-148-17) and b) 100 case of 10 mL Unit ...
Oral Drugs·45,940 affected·Mar 11, 2022
High RiskFDA
Sartorius Corporation
Virus Counter Platform with Model Name VC3100
Medical Devices·82 affected·Mar 11, 2022
High RiskFDA
Abbott Vascular
Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-...
Medical Devices·7 affected·Mar 11, 2022