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High RiskFDA
Sun Pharmaceutical Industries, Inc.
Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ
Oral Drugs·207,585 affected·Dec 26, 2019
High RiskFDA
Aaa Pharmaceutical, Inc.
Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
Oral Drugs·34,272 affected·Dec 26, 2019
High RiskFDA
Aaa Pharmaceutical, Inc.
Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
Oral Drugs·31,536 affected·Dec 26, 2019
High RiskFDA
Lupin Pharmaceuticals Inc.
Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: ...
Oral Drugs·41,863 affected·Dec 26, 2019
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blister card (NDC 62756-521-69) and b) 100 count bottles, (NDC 6...
Oral Drugs·384 affected·Dec 26, 2019
High RiskFDA
Cardinal Health Inc.
Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
Medical Devices·114,731 affected·Dec 26, 2019
High RiskFDA
Cardinal Health Inc.
Kangaroo 924 Safety Screw Spike Set, Product Code 775759
Medical Devices·114,731 affected·Dec 26, 2019
High RiskFDA
Cardinal Health Inc.
Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100
Medical Devices·114,731 affected·Dec 26, 2019
High RiskFDA
Flowonix Medical Inc
Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
Medical Implants·6,670 affected·Dec 24, 2019
High RiskFDA
Flowonix Medical Inc
Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country l...
Medical Implants·1,083 affected·Dec 24, 2019
High RiskFDA
Sauer Brands, Inc. - New Century
Royal Farms Barbecue Dipping Sauce, Net Wt. 1.5 OZ Distributed by Royal Farms, Baltimore MD packaged in plastic cups, 228 cups to a case.
Food·222 affected·Dec 23, 2019
High RiskFDA
Gsk Consumer Health, Inc
Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton. Distributed by: GSK Consumer Healthcare, Warren, NJ 070...
Drugs·431,614 affected·Dec 23, 2019
High RiskFDA
Jjgc Industria E Comercio De Materials Dentarios Sa
Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.
Medical Devices·2 affected·Dec 23, 2019
High RiskFDA
Nikon Metrology
Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225.
Medical Devices·110 affected·Dec 23, 2019
High RiskFDA
Carroll-baccari, Inc.
LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)
Medical Devices·8,030 affected·Dec 23, 2019
High RiskFDA
Ge Healthcare, Llc
SIGNA Architect Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support...
Medical Devices·62 affected·Dec 23, 2019
High RiskFDA
Ge Healthcare, Llc
SIGNA Pioneer Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support h...
Medical Devices·62 affected·Dec 23, 2019
High RiskFDA
Ge Healthcare, Llc
SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support h...
Medical Devices·62 affected·Dec 23, 2019
High RiskFDA
Assurance Infusion
LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial Assurance Infusion (713) 533-8800
Drugs·2 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·4 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
HYDROM 1MG/MORP 20MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Denton Pharma, Inc.
Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC ...
Oral Drugs·1,341 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800
Drugs·2 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
FENTANYL 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800
Drugs·5 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
MORPHINE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Drugs·134 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
HYDROM 17MG/PRIALT 5MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·2 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Drugs·10 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
HYDROMORPHONE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
IPAMORELIN 2000MCG/ML INJ in 2 mL vial Assurance Infusion (713) 533-8800
Drugs·5 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 20MG/SUF 105MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Drugs·10 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019
High RiskFDA
Assurance Infusion
BUP 30MG/ FENT 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800
Drugs·1 affected·Dec 20, 2019