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High RiskFDA
Bayshore Pharmaceuticals
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kath...
Oral Drugs·3,984 affected·Aug 19, 2020
High RiskFDA
Bayshore Pharmaceuticals
Metformin Hydrochloride Extended-Release Tablets USP, 500 mg 1000 Tablets Rx Only Manufactured by: Beximco Pharmaceuticals, LTD. 126, Kat...
Oral Drugs·594 affected·Aug 19, 2020
High RiskFDA
Ansell Healthcare Products Llc
MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medica...
Medical Devices·1,312 affected·Aug 19, 2020
High RiskFDA
Grupo Yacana Mexico Sas De Cv
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Grupo Yacana Mexico SAS de CV Ave. Alfonso reyes 71...
Topical Drugs·55,560 affected·Aug 18, 2020
High RiskFDA
Grupo Yacana Mexico Sas De Cv
Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufactured by: Greensys of North America LLC. 5001 W Military Hwy ...
Topical Drugs·43,728 affected·Aug 18, 2020
High RiskFDA
Nanomateriales Sa De Cv
Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33.8 fl oz (1.06 qt) (1L) (NDC 69912-008-01 UPC 2 000000 53115...
Topical Drugs·19,440 affected·Aug 18, 2020
High RiskFDA
Nanomateriales Sa De Cv
Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in 25 kg bottles, Distributed by Fujimura Trading S.A. DE C.V. Juve...
Topical Drugs·1,000 affected·Aug 18, 2020
High RiskFDA
Ameditech Inc
First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B
Medical Devices·99,900 affected·Aug 18, 2020
High RiskFDA
Ameditech Inc
Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC150; OPI300/MET500; AMP500/BZO300; ...
Medical Devices·13,700 affected·Aug 18, 2020
High RiskFDA
Ameditech Inc
ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2...
Medical Devices·27,375 affected·Aug 18, 2020
High RiskFDA
Ameditech Inc
Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ ED...
Medical Devices·3,600 affected·Aug 18, 2020
High RiskFDA
Ameditech Inc
TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Drugs of Abuse Cup AMP300/BZO200/COC300/MET300/OPI300/ THC5...
Medical Devices·26,775 affected·Aug 18, 2020
High RiskFDA
Ameditech Inc
Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUP...
Medical Devices·31,800 affected·Aug 18, 2020
High RiskFDA
Ameditech Inc
First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B
Medical Devices·47,005 affected·Aug 18, 2020
High RiskFDA
Ameditech Inc
Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14 /"Consult Diagnostics DRUGS OF ABUSE TEST CUP ...
Diagnostic Devices·31,600 affected·Aug 18, 2020
High RiskFDA
Beckman Coulter Inc.
UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent f...
Diagnostic Devices·219 affected·Aug 18, 2020
High RiskFDA
Ameditech Inc
ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup¿ Drug Screen Cup COC300/MET500/OPI300/THC50/AMP1000/PCP25/...
Medical Devices·189,175 affected·Aug 18, 2020
High RiskFDA
Ameditech Inc
iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC...
Medical Devices·136,925 affected·Aug 18, 2020
High RiskFDA
Ameditech Inc
First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B
Medical Devices·41,340 affected·Aug 18, 2020
High RiskFDA
Ameditech Inc
QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ Drug Screen Dipcard 11 Drug Detection: COC300+OPI300+MET500+...
Medical Devices·170,425 affected·Aug 18, 2020
High RiskFDA
Ameditech Inc
ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+TH...
Medical Devices·51,075 affected·Aug 18, 2020
High RiskFDA
Ameditech Inc
First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B
Medical Devices·537,120 affected·Aug 18, 2020
High RiskFDA
Ameditech Inc
Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug ...
Medical Devices·303,100 affected·Aug 18, 2020
High RiskFDA
Ameditech Inc
Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test ...
Medical Devices·67,300 affected·Aug 18, 2020
High RiskFDA
Ameditech Inc
MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH...
Medical Devices·12 affected·Aug 18, 2020
High RiskFDA
Arthrocare Corporation
Speed Stitch Needle Cassette
Medical Devices·6,366 affected·Aug 17, 2020
High RiskFDA
Hikma Pharmaceuticals Usa Inc.
Buprenorphine HCl Injection, 0.3 mg/mL, 1 mL vial, For Intramuscular or Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutic...
Injectable Drugs·97,890 affected·Aug 14, 2020
High RiskFDA
Grupo Asimex De Mexico Sa De Cv
Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles...
Drugs·0 affected·Aug 14, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionucl...
Medical Devices·412 affected·Aug 14, 2020
High RiskFDA
Ge Healthcare, Llc
NM/CT 850 Model Number: H3907AD
Medical Devices·25 affected·Aug 14, 2020
High RiskFDA
Ge Healthcare, Llc
Discovery NM 630 Model # H3101RH
Medical Devices·62 affected·Aug 14, 2020
High RiskFDA
Ge Healthcare, Llc
Discovery NM670 Pro Model # H3100XB
Medical Devices·9 affected·Aug 14, 2020
High RiskFDA
Battelle Memorial Institute
Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirat...
Respiratory Devices·898 affected·Aug 13, 2020
High RiskFDA
Sobel Westex
SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/health...
Medical Devices·3,380,850 affected·Aug 13, 2020
High RiskFDA
Pharmaceutical Innovations, Inc.
Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on w...
Medical Devices·0 affected·Aug 13, 2020
High RiskFDA
Medline Industries Inc
Central Line Dressing Change Tray
Medical Devices·60 affected·Aug 12, 2020
High RiskFDA
Covidien, Lp
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staple...
Medical Devices·900,007 affected·Aug 12, 2020
High RiskFDA
Covidien, Lp
Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The...
Medical Devices·900,007 affected·Aug 12, 2020
High RiskFDA
Stryker Medical Division Of Stryker Corporation
Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the pa...
Medical Devices·110 affected·Aug 12, 2020
High RiskFDA
Covidien, Lp
Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applic...
Medical Devices·900,007 affected·Aug 12, 2020
High RiskFDA
Covidien, Lp
Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal s...
Medical Devices·900,007 affected·Aug 12, 2020
High RiskFDA
Covidien, Lp
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staple...
Medical Devices·900,007 affected·Aug 12, 2020
High RiskFDA
United Natural Trading Inc. Dba Woodstock Farms
Price Chopper, Southwest Tex-Mex Trail Mix, 12 oz. re-closeable bag, 6 packages per case
Food·96 affected·Aug 11, 2020
High RiskFDA
Almark Foods
ORGANIC VALLEY EGG BITES feta & chives NET WT 4 OZ (114g) UPC# 0 93966 81195 7 Distributed by Organic Valley, La Farge, WI 54639
Food·2,845 affected·Aug 11, 2020
High RiskFDA
Randox Laboratories Ltd.
Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of La...
Medical Devices·4 affected·Aug 11, 2020
High RiskFDA
Randox Laboratories Ltd.
Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determinatio...
Medical Devices·21 affected·Aug 11, 2020
High RiskFDA
Cook Inc.
Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal ao...
Medical Devices·684 affected·Aug 11, 2020
High RiskFDA
Par Pharmaceutical Inc.
BusPIRone Hydrochloride Tablets, USP 7.5 mg NDC# 49884-725-01
Oral Drugs·11,347 affected·Aug 10, 2020