FDA recalls, December 2018: 128 published

75 different companies appear this month.

Risk classification: Class I: 23 · Class II: 88 · Class III: 17

Same month, other agencies:CPSC 19 recallsFSIS 10 recallsNHTSA 59 recalls

Recalls this month

DateProduct
December 19, 2018Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-…D-0328-2019Mylan Laboratories Limited, (Nashik FDF)
December 19, 2018Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co., LTD. NDC: 0…D-0296-2019LGM Pharma LLC
December 19, 2018Sebastiano's Naturally Flavored Gourmet Syrups Hazelnut 25.4 fl oz (750 ml)F-0714-2019Frutarom USA Inc.
December 19, 2018Apricot Chai Tea, 8 oz. Loose. UPC 41427-96317F-0702-2019Cedar Lake Tea
December 19, 2018Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India…D-0321-2019Mylan Laboratories Limited, (Nashik FDF)
December 19, 2018Schwan's Sea Salt Carmel Cashew Ice Cream (#206). Net Wt 56 oz.F-0703-2019Schwan's Global Supply Chain, Inc.
December 19, 2018Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6…D-0332-2019Mylan Laboratories Limited, (Nashik FDF)
December 19, 2018Gatorade, Lemon Lime, 20.3 FL OZ, Cont. Neto (600 mL)F-0709-2019The Gatorade Puerto Rico Co
December 19, 2018Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India,…D-0322-2019Mylan Laboratories Limited, (Nashik FDF)
December 19, 2018Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor th…Z-0601-2019Tosoh Bioscience Inc
December 19, 2018Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for…D-0316-2019Mylan Pharmaceuticals Inc.
December 19, 2018Baraka Hot Curry Powder packed in 7 OZ Plastic JarF-0715-2019U.B.C. Food Distributors INC.
December 19, 2018Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction…Z-0604-2019The Binding Site Group, Ltd.
December 19, 2018FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloa…D-0293-2019CAO Group, Inc.
December 19, 2018Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Pharmaceutical…D-0300-2019Westminster Pharmaceuticals Llc
December 19, 2018SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP…D-0291-2019CAO Group, Inc.
December 19, 2018Imperial Taste Fried Red Onion, Cu Hanh Phi; 24 x 8oz. Item #1760, UPC Code: 7418610176…F-0700-2019Gemini Food Corporation Inc
December 19, 2018Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for…D-0327-2019Mylan Laboratories Limited, (Nashik FDF)
December 19, 2018Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count …D-0310-2019Teva Pharmaceuticals USA
December 19, 2018Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India…D-0320-2019Mylan Laboratories Limited, (Nashik FDF)
December 19, 2018fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded …D-0290-2019CAO Group, Inc.
December 19, 2018Gatorade, Frost Glacier Freeze, Cont. Neto (600 mL)F-0705-2019The Gatorade Puerto Rico Co
December 19, 2018Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manuf…D-0294-2019Dr. Reddy's Laboratories, Inc.
December 19, 2018Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in Ind…D-0312-2019Mylan Pharmaceuticals Inc.
December 19, 2018Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378…D-0329-2019Mylan Laboratories Limited, (Nashik FDF)
December 19, 2018Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for:…D-0325-2019Mylan Laboratories Limited, (Nashik FDF)
December 19, 2018Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & …D-0306-2019Teva Pharmaceuticals USA
December 19, 2018Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in In…D-0318-2019Mylan Pharmaceuticals Inc.
December 19, 2018Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx On…D-0317-2019Mylan Pharmaceuticals Inc.
December 19, 2018Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & …D-0304-2019Teva Pharmaceuticals USA
December 19, 2018Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 9…D-0305-2019Teva Pharmaceuticals USA
December 19, 2018Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-…Z-0580-2019Leoni Fiber Optics GmbH
December 19, 2018Jackie's Cookie Babies Classic Chocolate Chip Net Wt. 28oz Manufactured and distribu…F-0725-2019JACKIE'S COOKIE CONNECTION LLC
December 19, 2018Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in Ind…D-0311-2019Mylan Pharmaceuticals Inc.
December 19, 2018CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representative…Z-0576-2019CIVCO Medical Instruments Co., Inc.
December 19, 2018SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracke…Z-0567-2019CIVCO Medical Instruments Co., Inc.
December 19, 2018Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 9…D-0303-2019Teva Pharmaceuticals USA
December 19, 20184Patriots Chicken a la King CONTAINS: Wheat, Coconut NET WT. 10.0 oz (284 g)F-0704-20194Patriots, LLC
December 19, 2018Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for…D-0326-2019Mylan Laboratories Limited, (Nashik FDF)
December 19, 2018Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for:…D-0315-2019Mylan Pharmaceuticals Inc.
December 12, 2018NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnec…Z-0526-2019Neomed Inc
December 12, 2018Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Impl…Z-0553-2019Zimmer Biomet, Inc.
December 12, 2018Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Con…Z-0529-2019Helena Laboratories, Inc.
December 12, 2018Smartypants Kids Complete, Non GMO Multi and omega 3's vitamin D3 for bones, vitamin B1…F-0683-2019Smartypants Vitamins
December 12, 2018Green Cedar Ackawi cheese in small clear plastic shrink wrapped packaging bearing a sell…F-0751-2019Harb Dairy, Inc. DBA Green Cedar Dairy
December 12, 2018Vanilla Chocolate Chip ice cream (item #67017), packaged in 1.75 qt. container. UPC 0 728…F-0694-2019TILLAMOOK COUNTY CREAMERY ASSOC
December 12, 2018Tillamook Mudslide ice cream (item #63006), packaged in 3 gallon tub. UPC 0 72830 63006 1…F-0692-2019TILLAMOOK COUNTY CREAMERY ASSOC
December 12, 201816 count Crunch & Pop Mix Variety Pack SackF-0690-2019Frito-Lay, Inc.
December 12, 2018Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distri…D-0289-2019Aurobindo Pharma USA Inc.
December 12, 2018SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray,…D-0298-2019Fresenius Kabi USA, LLC

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