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High RiskFDA
Ethicon Endo-surgery Inc
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
Medical Devices·1,059 affected·May 15, 2019
High RiskFDA
Ethicon Endo-surgery Inc
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C
Medical Devices·228 affected·May 15, 2019
High RiskFDA
Renaissance Food Group Llc
365 by Whole Foods Market Smoked Mozzarella Pasta Salad packaged in a clear plastic clamshell 8 Oz. and a salad bar item UPC 81641602257
Produce·72 affected·May 14, 2019
High RiskFDA
Renaissance Food Group Llc
365 by Whole Foods Market Classic Potato Salad packaged in a clear plastic clamshell 8 Oz. and a salad bar item UPC 81641602117
Produce·120 affected·May 14, 2019
High RiskFDA
Renaissance Food Group Llc
365 by Whole Foods Market Traditional Egg Salad packaged in a clear plastic clamshell 9 Oz. UPC 81641602115
Produce·132 affected·May 14, 2019
High RiskFDA
Renaissance Food Group Llc
Veggie Crudite Bowl with Jicama and Mini Peppers packaged in a Clear plastic bowl 34.5 Oz. UPC 82676681079
Food·256 affected·May 14, 2019
High RiskFDA
Renaissance Food Group Llc
Veggie Crudite Bowl with Asparagus and Bell Peppers packaged in a Clear plastic bowl 34.5 Oz. UPC 82676681078
Food·274 affected·May 14, 2019
High RiskFDA
American Health Packaging
Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packagi...
Oral Drugs·3,015 affected·May 13, 2019
High RiskFDA
American Health Packaging
Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging...
Oral Drugs·6,643 affected·May 13, 2019
High RiskFDA
Mallinckrodt Pharmaceuticals
Amitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-080-60
Oral Drugs·89,808 affected·May 13, 2019
High RiskFDA
American Health Packaging
Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging...
Oral Drugs·8,777 affected·May 13, 2019
High RiskFDA
American Health Packaging
Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Co...
Oral Drugs·16,698 affected·May 13, 2019
High RiskFDA
Mallinckrodt Pharmaceuticals
Amitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma Americas, LLC, NDC 64764-240-60
Oral Drugs·80,640 affected·May 13, 2019
High RiskFDA
Becton Dickinson & Company
BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
Medical Devices·0 affected·May 13, 2019
High RiskFDA
Becton Dickinson & Company
BD Microtainer SST- Amber Part/Catalog Number: 365978
Medical Devices·0 affected·May 13, 2019
High RiskFDA
Becton Dickinson & Company
BD Microtainer SST Part/Catalog No.365967
Medical Devices·0 affected·May 13, 2019
High RiskFDA
Becton Dickinson & Company
BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987
Medical Devices·0 affected·May 13, 2019
High RiskFDA
Becton Dickinson & Company
BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963
Medical Devices·0 affected·May 13, 2019
High RiskFDA
Cadence Science, Inc.
Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404)...
Medical Devices·237 affected·May 10, 2019
High RiskFDA
Phadia Ab
EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM clas...
Medical Devices·30 affected·May 10, 2019
High RiskFDA
American Health Packaging
Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manufactured by: Cadi...
Oral Drugs·375,921 affected·May 9, 2019
High RiskFDA
American Health Packaging
Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged and Distributed by: American Health Packaging, ...
Oral Drugs·15,386 affected·May 9, 2019
High RiskFDA
I.t.s. Gmbh
Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until b...
Medical Implants·65 affected·May 9, 2019
High RiskFDA
Abbott Laboratories
Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label...
Medical Devices·22 affected·May 9, 2019
High RiskFDA
Xhale Assurance, Inc.
Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance¿ Nasal Alar SpO2 Sensor is indicated for s...
Respiratory Devices·701,272 affected·May 8, 2019
High RiskFDA
Zydus Pharmaceuticals Usa Inc
MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01
Oral Drugs·34,521 affected·May 6, 2019
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distribute...
Oral Drugs·168,330 affected·May 6, 2019
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Z...
Oral Drugs·768 affected·May 6, 2019
High RiskFDA
Zydus Pharmaceuticals Usa Inc
MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11
Oral Drugs·40,872 affected·May 6, 2019
High RiskFDA
Zydus Pharmaceuticals Usa Inc
MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18
Oral Drugs·0 affected·May 6, 2019
High RiskFDA
Geritrex, Llc
Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 54...
Drugs·24,312 affected·May 6, 2019
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed...
Oral Drugs·215,760 affected·May 6, 2019
High RiskFDA
Zydus Pharmaceuticals Usa Inc
MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA I...
Oral Drugs·0 affected·May 6, 2019
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distribut...
Oral Drugs·143,184 affected·May 6, 2019
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distribute...
Oral Drugs·47,664 affected·May 6, 2019
High RiskFDA
Zydus Pharmaceuticals Usa Inc
ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Phar...
Oral Drugs·1,425,264 affected·May 6, 2019
High RiskFDA
Geritrex, Llc
Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, N...
Drugs·1,536 affected·May 6, 2019
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distr...
Oral Drugs·204 affected·May 6, 2019
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68...
Oral Drugs·3,156 affected·May 6, 2019
High RiskFDA
Zydus Pharmaceuticals Usa Inc
MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11
Oral Drugs·13,564 affected·May 6, 2019
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed b...
Oral Drugs·113,304 affected·May 6, 2019
High RiskFDA
Neurologica Corporation
Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generat...
Medical Devices·288 affected·May 6, 2019
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 ...
Surgical Devices·163 affected·May 6, 2019
High RiskFDA
Qiagen Sciences, Inc.
RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended for the purification of total RNA from ...
Diagnostic Devices·31 affected·May 6, 2019
High RiskFDA
Back Roads Food Company
Back Roads Granola: Nut Free Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
Bakery & Grains·0 affected·May 3, 2019
High RiskFDA
Back Roads Food Company
Back Roads Granola: Maple Spice Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
Bakery & Grains·0 affected·May 3, 2019
High RiskFDA
Back Roads Food Company
Back Roads Granola: Coconut Crunch Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
Bakery & Grains·0 affected·May 3, 2019
High RiskFDA
Back Roads Food Company
Back Roads Granola: Ancient Grains Best by date: 01/11/20-02/2/20 In 10 oz, 12 oz, 2.45lb, 3 lb, and 28lb
Bakery & Grains·0 affected·May 3, 2019