FDA recalls, September 2018: 158 published

62 different companies appear this month.

Risk classification: Class I: 16 · Class II: 130 · Class III: 12

Same month, other agencies:CPSC 23 recallsFSIS 8 recallsNHTSA 99 recalls

Recalls this month

DateProduct
September 5, 2018Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) b…D-1169-2018Pfizer Global Supply
September 5, 2018Ararat Cut Beets; 19 oz. glass jar; Ingredients: Cut Beets, Water, Salt, Sugar,…F-1905-2018Artashes LLC
September 5, 2018Consumer Packaging (PET bottle): Minute Maid TROPICAL BLEND Flavored Juice Beverage 12 FL…F-1906-2018The Coca-Cola Company
September 5, 2018Bright Light Chard was shipped in card board boxes that are labeled with the firm name "H…F-1925-2018Howard Calcagno Farms
September 5, 2018Beet was shipped in card board boxes that are labeled with the firm name "Howard Calcagno…F-1922-2018Howard Calcagno Farms
September 5, 2018Ararat Imambayeldy; 18.3 oz. glass jar; Ingredient: Eggplant, tomato paste, onions, …F-1902-2018Artashes LLC
September 5, 2018QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part…Z-2902-2018Stryker Leibinger GmbH & Co. KG
September 5, 2018GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systemsZ-2954-2018GE Medical Systems China Co., Ltd.
September 5, 2018Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packagi…Z-2943-2018Bard Medical Division
September 5, 2018Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufac…D-1130-2018AVKARE Inc.
September 5, 2018Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manuf…D-1138-2018Torrent Pharma Inc.
September 5, 2018Kale was shipped in card board boxes that are labeled with the firm name "Howard Calcagno…F-1910-2018Howard Calcagno Farms
September 5, 2018Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach,…D-1154-2018Pharmcore Inc.
September 5, 2018Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufac…D-1133-2018AVKARE Inc.
September 5, 2018Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manuf…D-1140-2018Torrent Pharma Inc.
September 5, 2018Red Chard was shipped in card board boxes that are labeled with the firm name "Howard Cal…F-1923-2018Howard Calcagno Farms
September 5, 2018Premo Brand Turkey & Cheese Wedge sandwiches 5 OZ retail UPC 612510002018 Plastic tr…F-1929-2018Lipari Foods Operating Company, LLC dba JLM Manufacturing
September 5, 2018Ararat Eggplant Paste 18.3 oz. glass jar; Ingredients: Eggplants, Red pepper (f…F-1903-2018Artashes LLC
September 5, 2018AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, …Z-2912-2018Stryker Leibinger GmbH & Co. KG
September 5, 2018Parsley was shipped in card board boxes that are labeled with the firm name "Howard Calca…F-1920-2018Howard Calcagno Farms
September 5, 2018CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central Drugs Compo…D-1156-2018Auro Pharmacies, Inc.
September 5, 2018Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02;…D-1127-2018PD-Rx Pharmaceuticals, Inc.
September 5, 2018Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard…D-1146-2018RemedyRepack Inc.
September 5, 2018Mustard was shipped in card board boxes that are labeled with the firm name "Howard Calca…F-1912-2018Howard Calcagno Farms
September 5, 2018Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended fo…Z-2948-2018Medline Industries Inc
September 5, 20180.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation De…D-1128-2018Baxter Healthcare Corporation
September 5, 2018Methyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose via…D-1160-2018Auro Pharmacies, Inc.
September 5, 2018Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx…D-1168-2018Akorn, Inc.
September 5, 2018Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL …D-1153-2018Pharmcore Inc.
September 5, 2018WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 …Z-2878-2018Biosense Webster, Inc.
September 5, 2018Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pha…D-1134-2018Torrent Pharma Inc.
September 5, 2018Living Well Remedies Weight Away Remedy, 2 fl oz (59 mL) Distributed by Living Well Remed…D-0004-2019Living Well Remedies, LLC
September 5, 2018Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Ph…D-1136-2018Torrent Pharma Inc.
September 5, 2018Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manu…D-1137-2018Torrent Pharma Inc.
September 5, 2018Testosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 m…D-1163-2018Auro Pharmacies, Inc.
September 5, 2018Tipu's Chai - Sweetened Masala Chai, Net wt.7.5 oz. per box. UPC #: 7 19196 20035 3. Eac…F-1857-2018Tipu'S Chai
September 5, 2018Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Central Drugs C…D-1167-2018Auro Pharmacies, Inc.
September 5, 2018Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Va…D-1171-2018Validus Pharmaceuticals, Inc.
September 5, 2018Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compo…D-1159-2018Auro Pharmacies, Inc.
September 5, 2018Green Leaf Lettuce was shipped in card board boxes that are labeled with the firm name "H…F-1915-2018Howard Calcagno Farms
September 5, 2018Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharma…D-1170-2018Validus Pharmaceuticals, Inc.
September 5, 2018Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tabl…D-1142-2018Torrent Pharma Inc.
September 5, 2018Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufa…D-1132-2018AVKARE Inc.
September 5, 2018Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Ha…D-1152-2018Pharmcore Inc.
September 5, 2018Mexican Style Ricotta Cheese labeled, "Don Froylan Requeson***Mexican Style Ricotta Chees…F-1908-2018Ochoa's Queseria LLC
September 5, 2018Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets…D-1145-2018Torrent Pharma Inc.
September 5, 2018Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Ph…D-1135-2018Torrent Pharma Inc.
September 5, 2018Bok Choy was shipped in card board boxes that are labeled with the firm name "Howard Calc…F-1918-2018Howard Calcagno Farms
September 5, 2018Chocolate Chip Cookies, brand Cafe YUMM! Product is packaged in shrink wrapped master ca…F-1852-2018Marsee Foods Inc
September 5, 2018Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufa…D-1129-2018Mayne Pharma Inc

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