FDA recalls, August 2015: 119 published

46 different companies appear this month.

Risk classification: Class I: 25 · Class II: 87 · Class III: 7

Same month, other agencies:CPSC 28 recallsFSIS 12 recallsNHTSA 73 recalls

Recalls this month

DateProduct
August 19, 2015Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Pro…Z-2360-2015Stryker Howmedica Osteonics Corp.
August 19, 2015JAMES FARM GARDEN PEAS CHICHAROS, NET Wt. 40 OZ (2.5 LBS), FRESH FROZEN, UPC 7 60695 0100…F-2959-2015Restaurant Depot
August 19, 2015ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S…Z-2363-2015Stryker Howmedica Osteonics Corp.
August 19, 2015SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, …D-1323-2015GlaxoSmithkline Consmer Healthcare
August 19, 2015SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech, South Jord…D-1322-2015GlaxoSmithkline Consmer Healthcare
August 19, 2015biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes…D-1318-2015GlaxoSmithkline Consmer Healthcare
August 19, 2015SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufactured by Oratech…D-1321-2015GlaxoSmithkline Consmer Healthcare
August 19, 2015biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, U…D-1317-2015GlaxoSmithkline Consmer Healthcare
August 19, 2015Coenzyme Q-10 50 mg label reads in part, "***Major***CO Q-10 50 MG***For healthy HEART & …F-2951-2015Mason Vitamins, Inc.
August 12, 2015Siemens Artis zee systems; dedicated angiography systems developed for single and biplan…Z-2340-2015Siemens Medical Solutions USA, Inc
August 12, 2015Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by Perrigo, Yeru…D-1286-2015Perrigo Israel Pharmaceuticals
August 12, 2015Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis…D-1285-2015Actavis Laboratories, FL, Inc.
August 12, 2015Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301Z-2338-2015Siemens Medical Solutions USA Inc.
August 12, 2015Pineapple popsicle, La Jalpita brand, 3 Fl oz., UPC 651821269758.F-2924-2015Paleteria La Jalpita
August 12, 2015SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pha…D-1310-2015The Apothecary Shoppe LLC
August 12, 2015SIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, T…D-1309-2015The Apothecary Shoppe LLC
August 12, 2015Vanilla bolis (tube), La Jalpita brand, 3.5 Fl oz., No UPCF-2926-2015Paleteria La Jalpita
August 12, 2015Vanilla -Vainilla popsicle, La Jalpita brand, 3 Fl oz, UPC 651821269758.F-2927-2015Paleteria La Jalpita
August 12, 2015SIU-Papav/Phentol 30/.5 mg/mL Injection, Rx Only, 3 mL Vial, Apothecary Shoppe, Compoundi…D-1299-2015The Apothecary Shoppe LLC
August 12, 2015Outer carton : Nabisco Newtons Fig 24-2 OZ (56 g) Packs Net Wt 3 lbs Mondelez Interna…F-2932-215Mondelez International
August 12, 2015S-Chorionic Gonad HCG 1000 U/mL Injection, Rx Only, 4 mL Vial, Apothecary Shoppe, Compoun…D-1290-2015The Apothecary Shoppe LLC
August 12, 2015Danish Rolls, 4 Ct., Net Wt. 13oz. in clear plastic clam shell.F-2936-2015Supervalu, Inc.
August 12, 2015Walnut bolis (tube), La Jalpita brand, 3.5 fl. oz. No UPC. This product contains artif…F-2917-2015Paleteria La Jalpita
August 12, 2015Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC …D-1287-2015GlaxoSmithkline Consmer Healthcare
August 12, 2015SIU-Papav/Phent 30/1 mg Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmac…D-1298-2015The Apothecary Shoppe LLC
August 12, 2015IQF Italian Cut Green Beans (each tote 1350 lbs) lot 880804 Harvest Delight Italian G…F-2935-2015Inn Foods Inc.
August 12, 2015S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clam…Z-2326-2015Aesculap, Inc.
August 12, 2015SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharma…D-1308-2015The Apothecary Shoppe LLC
August 12, 2015Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx O…D-1288-2015Ranbaxy Inc.
August 12, 2015S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Shoppe, Compoun…D-1316-2015The Apothecary Shoppe LLC
August 12, 2015Pepino c/ chile popsicle, La Jalpita brand, 3 Fl oz., UPC 651821269758.F-2923-2015Paleteria La Jalpita
August 12, 2015SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharma…D-1303-2015The Apothecary Shoppe LLC
August 12, 2015SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shop…D-1312-2015The Apothecary Shoppe LLC
August 12, 2015Mango popsicle, La Jalpita brand, 3 Fl oz., UPC 651821269758.F-2921-2015Paleteria La Jalpita
August 5, 2015Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM…Z-2235-2015EXP Pharmaceutical Services Corp
August 5, 2015Pasteurized Prepared Cheese Product: BORDEN 12/13.12OZ DTT AMERICAN CHEDDAR PROD, 451…F-2892-2015Dairy Farmers OF America Inc
August 5, 2015Fat Free Pasteurized Prepared Cheese Product: BORDEN 12/12OZ SHARP CHEDDAR FAT FREE YL…F-2901-2015Dairy Farmers OF America Inc
August 5, 2015Fat Free Pasteurized Prepared Cheese Product: ESSENTIAL EVERYDAY 12/10.7OZ SINGLES WHI…F-2902-2015Dairy Farmers OF America Inc
August 5, 2015ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting shaping bone i…Z-2283-2015The Anspach Effort, Inc.
August 5, 2015Pasteurized Prepared Cheese Product: BORDEN 12/8OZ SWISS SINGLES CHEESE PROD WHT, 5300…F-2889-2015Dairy Farmers OF America Inc
August 5, 2015ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1. Cutting shaping bone i…Z-2294-2015The Anspach Effort, Inc.
August 5, 2015Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek/Mylar, Ster…Z-2239-2015EXP Pharmaceutical Services Corp
August 5, 2015Nut Free Pesto, packaged in a institutional size 28 lbs. and 30 lbs. container, sold und…F-2869-2015Rising Sun Farms Inc
August 5, 2015Flavored Pasteurized Prepared Cheese Product: COBURN FARMS 12/12OZ SINGLES PEPPER JACK…F-2895-2015Dairy Farmers OF America Inc
August 5, 2015Non-Fat Pasteurized Prepared Cheese Product: FOOD CLUB 12/12OZ AMER FAT FREE YELLOW, 3…F-2876-2015Dairy Farmers OF America Inc
August 5, 2015Swiss Style Cheese Alternative: LISANATTI FOODS, SOY- SATION 12/8OZ SWISS STYLE SLICES…F-2877-2015Dairy Farmers OF America Inc
August 5, 2015Fat Free Pasteurized Prepared Cheese Product: HYVEE 12/12OZ FAT FREE SWISS CHS, 754500…F-2903-2015Dairy Farmers OF America Inc
August 5, 2015Pasteurized Prepared Cheese Product: .BORDEN 12/10.67OZ GRILLED CHEESE MELTS YLW PP2.9…F-2888-2015Dairy Farmers OF America Inc
August 5, 2015Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01)…D-1280-2015Mutual Pharmaceutical Company, Inc.
August 5, 2015White Cheddar Flavor Cheese Alternative: SOYA KAAS 12/8OZ WHITE CHEDDAR FLAVOR SLICES,…F-2878-2015Dairy Farmers OF America Inc

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