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High RiskFDA
Chicago Bar Company Llc Rxbar
RXBAR: Chocolate Hazelnut, 1.83oz bars single bar, 12-count carton, 4-count carton
Snacks & Candy·75,695,266 affected·Dec 19, 2018
High RiskFDA
Teva Pharmaceuticals Usa
Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle ...
Oral Drugs·181,456 affected·Dec 19, 2018
High RiskFDA
Roberts Home Medical Llc
Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical, Inc. Germa...
Drugs·9 affected·Dec 19, 2018
High RiskFDA
Reckitt Benckiser Llc
Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340...
Medical Devices·34,920 affected·Dec 19, 2018
High RiskFDA
Cincinnati Sub-zero Products Llc, A Gentherm Company
Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is ...
Respiratory Devices·396 affected·Dec 19, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomogra...
Cardiac Devices·24 affected·Dec 19, 2018
High RiskFDA
Reckitt Benckiser Llc
Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 0...
Medical Devices·1,761,044 affected·Dec 19, 2018
High RiskFDA
Cook Inc.
Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit Secure Gastrointestinal Su...
Surgical Devices·975 affected·Dec 19, 2018
High RiskFDA
Cook Inc.
Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure Gastrointestinal Su...
Surgical Devices·797 affected·Dec 19, 2018
High RiskFDA
Fannie May Confections Brands, Inc
Fannie May Pixies , Caramel and Pecan Clusters covered in Milk Chocolate 14 oz. Box - 12 units per case
Dairy·173,076 affected·Dec 18, 2018
High RiskFDA
Lgm Pharma Llc
CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP PHARM BEIJING CO., LTD, 12-2-620, Jia 69, Fushi Rd., Haidian...
Drugs·205 affected·Dec 18, 2018
High RiskFDA
Angiotech (manan Medical Products, Inc.)
Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy an...
Surgical Devices·1,404 affected·Dec 18, 2018
High RiskFDA
Angiotech (manan Medical Products, Inc.)
Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm
Medical Devices·2,502 affected·Dec 18, 2018
High RiskFDA
Ethicon, Inc.
PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indi...
Medical Devices·840 affected·Dec 18, 2018
High RiskFDA
Wilson-cook Medical Inc.
COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S
Surgical Devices·8 affected·Dec 18, 2018
High RiskFDA
Wilson-cook Medical Inc.
COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S
Surgical Devices·6 affected·Dec 18, 2018
High RiskFDA
Insulet Corporation
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Diabetes Devices·264 affected·Dec 18, 2018
High RiskFDA
Angiotech (manan Medical Products, Inc.)
J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Surgical Devices·180 affected·Dec 18, 2018
High RiskFDA
Angiotech (manan Medical Products, Inc.)
Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy a...
Surgical Devices·504 affected·Dec 18, 2018
High RiskFDA
Promise Pharmacy, Llc
Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding Specialist, 31818 US Hwy 19N, Palm Harbor FL 34...
Ophthalmic Drugs·75 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·2 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·2 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·7 affected·Dec 17, 2018
High RiskFDA
Duren Health Mart Pharmacy
Domperidone 10 mg capsules, 100-count per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 384...
Oral Drugs·840 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·94 affected·Dec 17, 2018
High RiskFDA
Duren Health Mart Pharmacy
Progesterone 10% cream, 12gm to 30gm per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485,...
Topical Drugs·200 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL 10 mL vial, R...
Supplements·204 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·37 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·927 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Prom...
Ophthalmic Drugs·900 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·1 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·11 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium, 25mg/50mg/50mg/1mg/100mg/0.4mcg...
Injectable Drugs·64 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx Only, Compounded Prescription, Promise Pharmacy C...
Injectable Drugs·3 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hw...
Ophthalmic Drugs·167 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·266 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo Drops: 3 mL Rx Only, Compounded Prescription, Promise...
Ophthalmic Drugs·250 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·416 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·3 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·5 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg/2.5mg/25mg/5mg/5mg/0.1mg/1...
Injectable Drugs·846 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm...
Injectable Drugs·5 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·30 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·93 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·59 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10 mL, Rx Only, Promise Pharmacy Compounding Specia...
Injectable Drugs·158 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·341 affected·Dec 17, 2018
High RiskFDA
Promise Pharmacy, Llc
Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
Injectable Drugs·1 affected·Dec 17, 2018