FDA recalls, February 2018: 326 published

77 different companies appear this month.

Risk classification: Class I: 32 · Class II: 275 · Class III: 19

Same month, other agencies:CPSC 24 recallsFSIS 8 recallsNHTSA 62 recalls

Recalls this month

DateProduct
February 28, 2018Hydroxyprogesterone Caproate USP for prescription compounding, packaged in a) 25g (NDC 58…D-0495-2018American Pharmaceutical Ingredients LLC
February 28, 2018Fentanyl Citrate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.D-0439-2018Pharmedium Services, LLC
February 28, 2018Sumatriptan Succinate USP for prescription compounding, 25g, RX only, packed by American …D-0521-2018American Pharmaceutical Ingredients LLC
February 28, 2018Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. …Z-0664-2018LivaNova USA
February 28, 2018Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4)…D-0484-2018American Pharmaceutical Ingredients LLC
February 28, 2018Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC 58597-8011-…D-0481-2018American Pharmaceutical Ingredients LLC
February 28, 2018Nicardipine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.D-0469-2018Pharmedium Services, LLC
February 28, 2018Prilocaine HCl USP for prescription compounding, packaged in a) 100g (NDC 58597-8028-6); …D-0517-2018American Pharmaceutical Ingredients LLC
February 28, 2018Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420)…Z-0643-2018Pentax of America Inc
February 28, 2018Clindamycin Phosphate USP for prescription compounding, packaged in a) 10g (NDC 58597-819…D-0479-2018American Pharmaceutical Ingredients LLC
February 28, 2018Clonidine HCl USP for prescription compounding, packaged in a) 5g (NDC 58597-8010-2); b) …D-0480-2018American Pharmaceutical Ingredients LLC
February 28, 2018ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for …Z-0638-2018Zimmer Biomet, Inc.
February 28, 2018HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging.D-0428-2018Pharmedium Services, LLC
February 28, 2018Estradiol Hemihydrate USP (Micronized) (Soy) for prescription compounding, packaged in a)…D-0489-2018American Pharmaceutical Ingredients LLC
February 28, 2018Vecuronium Bromide in Sterile Water for Injection in all strengths, all doses, and all pa…D-0462-2018Pharmedium Services, LLC
February 28, 2018Ephedrine Sulfate Injection in all strengths, all doses, and all packaging.D-0451-2018Pharmedium Services, LLC
February 28, 2018Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging.D-0429-2018Pharmedium Services, LLC
February 28, 2018Duloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 58597-8632-6); b…D-0487-2018American Pharmaceutical Ingredients LLC
February 28, 2018Phentolamine Mesylate USP for prescription compounding, packaged in a) 1g (NDC 58597-8077…D-0516-2018American Pharmaceutical Ingredients LLC
February 28, 2018Medroxyprogesterone Acetate USP (Micronized) for prescription compounding 1000 g, RX only…D-0510-2018American Pharmaceutical Ingredients LLC
February 28, 2018Tretinoin USP for prescription compounding, packaged in a) 5g (NDC 58597-8033-2); 1b) 10…D-0530-2018American Pharmaceutical Ingredients LLC
February 28, 2018Fentanyl Citrate Injection in all strengths, all doses, and all packaging.D-0450-2018Pharmedium Services, LLC
February 28, 2018Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY…Z-0645-2018Medtronic Perfusion Systems
February 28, 2018Desoximetasone USP (Micronized) for prescription compounding, 5g, RX only, packed by Ame…D-0483-2018American Pharmaceutical Ingredients LLC
February 28, 2018Italian White Bread Dough SticksF-0827-2018Aryzta North America
February 28, 2018Sumatriptan USP for prescription compounding, packaged in 10g (NDC 58597-8089-3); b) 25g …D-0522-2018American Pharmaceutical Ingredients LLC
February 28, 2018Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 58597-814…D-0536-2018American Pharmaceutical Ingredients LLC
February 28, 2018Lidocaine USP for prescription compounding, packaged in a) 25g (NDC 58597-8019-4); b) 100…D-0507-2018American Pharmaceutical Ingredients LLC
February 28, 2018Midazolam HCl in 5% Dextrose in all strengths, all doses, and all packaging.D-0435-2018Pharmedium Services, LLC
February 28, 2018Doxycycline Hyclate USP for prescription compounding, packaged in a) 25g (NDC 58597-8082-…D-0486-2018American Pharmaceutical Ingredients LLC
February 28, 2018Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (NDC 58597-800…D-0476-2018American Pharmaceutical Ingredients LLC
February 28, 2018Pressure Injectable Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Cat…Z-0651-2018Arrow International Inc
February 28, 2018Adenosine Injection in all strengths, all doses, and all packaging.D-0443-2018Pharmedium Services, LLC
February 28, 2018Glycopyrrolate in all strengths, all doses, and all packaging.D-0454-2018Pharmedium Services, LLC
February 28, 2018Testosterone (Soy) (Micronized) USP for prescription compounding, packaged in a) 25g (NDC…D-0525-2018American Pharmaceutical Ingredients LLC
February 28, 2018Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.D-0441-2018Pharmedium Services, LLC
February 28, 2018Naltrexone HCl USP (Dihydrate) for prescription compounding, packaged in a) 1g (NDC 58597…D-0511-2018American Pharmaceutical Ingredients LLC
February 28, 2018Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, all doses,…D-0463-2018Pharmedium Services, LLC
February 28, 2018Levetiracetam USP for prescription compounding, packaged in a) 500g (NDC 58597-8353-7); b…D-0502-2018American Pharmaceutical Ingredients LLC
February 21, 2018Toothette Oral Care Perox-A-Mint Solution, Oral Debriding Agent, 1.5 fl. oz./44 mL. packe…D-0350-2018Sage Products Inc
February 21, 2018Oral Cleansing & Suctioning System q2 with 0.12% Chlorexidine Gluconate (CHG) Oral Rinse.…D-0385-2018Sage Products Inc
February 21, 2018EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1…Z-0578-2018LITTLE RAPIDS CORPORATION
February 21, 2018Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages o…D-0381-2018Sage Products Inc
February 21, 2018Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System. Contains: Three…D-0411-2018Sage Products Inc
February 21, 2018Q.CareOral Cleansing & Suctioning System q2. Contains 1 Covered Yankauer Suction Handle a…D-0395-2018Sage Products Inc
February 21, 2018Independent Care System Corinz, Contains: 1.5 fl oz bottle Corinz Mouthwash, 0.5 oz/14g t…D-0362-2018Sage Products Inc
February 21, 2018BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spr…D-0421-2018Webrx dba RxPalace.com
February 21, 2018AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product U…Z-0627-2018Zimmer Biomet, Inc.
February 21, 2018Toothette Oral Care Suction Swab System with Perox-A-Mint Solution, Contains 6 Packages o…D-0380-2018Sage Products Inc
February 21, 2018Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer, Sucti…D-0393-2018Sage Products Inc

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