FDA recalls: August 2016
Every food and drug recall report the FDA published in August 2016: 242 reports, 159 of them Class I.
- Recall reports
- 242
- Class I (serious)
- 159
- Food
- 216
- Drugs
- 26
- Aug 31, 2016Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu,…Drug · Talon Compounding PharmacyLack of Assurance of SterilityClass II
- Aug 31, 2016Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials,…Drug · Talon Compounding PharmacyLack of Assurance of SterilityClass II
- Aug 31, 2016Remeven Cream, (50% Urea in a Cream Base), a) 5Drug · Stratus Pharmaceuticals IncCrystallization; Complaints that cream appears to have crystallizedClass III
- Aug 31, 2016Urea (50% Urea in a Cream Base), a) Net WtDrug · Exact-Rx IncCrystallization; complaints received by the manufacturer of crystals forming in productClass III
- Aug 31, 2016Amlodipine Besylate Tablets, USP, 2Drug · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.Class II
- Aug 31, 2016Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose b…Drug · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.Class II
- Aug 31, 2016Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose…Drug · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.Class II
- Aug 31, 2016Desoximetasone Gel USP, 0Drug · Akorn, Inc.Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time pointClass III
- Aug 31, 2016Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured…Drug · Teva North AmericaSuperpotent drug: Out of specification test result for assay during stability testing.Class II
- Aug 31, 2016Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle,…Drug · Actavis IncFailed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).Class III
- Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distributed by Act…
- 100% Organic Spelt Grain, packaged in 10 lbs
- 100% Organic Spelt Flour, packaged in 10 lbs
- 100% Organic Unbleached White Flour, packaged in 10 lbs
- Pacific Black Cod, NW Wild Products, 6
- Wild Columbia River Coho Salmon- Custom Smoked, NW Wild Products, 6
- Wild Columbia River Coho Salmon- Custom Packed, NW Wild Products, 6
- Columbia River Chinook Salmon -Custom Smoked, NW Wild Products, 6
- Columbia River Chinook Salmon -Custom Packed, NW Wild Products, 6
- Wild Steelhead Salmon - Custom Smoked-NW Wild Products, 6
- Wild Steelhead Salmon - Custom Packed-NW Wild Products, 6
- Oregon Sardines - Mustard-NW Wild Products, 6
- Oregon Sardines - Spicy Tomato-NW Wild Products, 6
- Wild Columbia River Sturgeon - Custom Smoked-NW Wild Products, 6
- Pacific White Albacore Tuna - Custom Smoked -NW Wild Products, 6
- Wild Northwest Razor Clams - Custom Smoked-NW Wild Products, 6
- Wild Northwest Razor Clams - Custom Packed-NW Wild Products, 6
- Pacific Black Cod- Custom Smoked -NW Wild Products, 6
- Oregon Sardines - Custom Smoked-NW Wild Products, 6
- Pacific White Albacore Tuna - Custom Packed -NW Wild Products, 6
- The Cheese & Berries Danish was labeled Pleasant Hill Ovens, Cheese Danish, Artificial…
- CINNAMON ROLLS WITH CREAM CHEESE ICING Quality & Value pics BY PRICE CHOPPER NET WT 12
- Agave Dream Cappuccino Ice Cream Pint UPC code: 899349002048
- Nabisco Honey Maid Teddy Grahams Cinnamon Cubs Graham Snacks Net Wt
- Eatin' Alive VEGAN GLUTEN FREE RAW thai peanut noodles
- Eatin' Alive VEGAN GLUTEN FREE RAW thai wrap
- la Torre Copito Marshmallow Chocolate Cookie NET WT 4
- LAXMI NUTKHHAT Golden Raisins
- OSSIE'S PICKLED LOX DAIRY
- OSSIE'S HERRING IN SOURCREAM
- OSSIE'S TAAM SHABBOS HERRING
- OSSIE'S STIGLITZ HERRING
- OSSIE'S WASABI HERRING
- OSSIE'S SWEDISH MATJES HERRING
- OSSIE'S DUBLIN HERRING
- OSSIE'S HONEY MUSTARD HERRING
- OSSIE'S PICKLED LOX & CREAM
- OSSIE'S SHMALTZ HERRING
- OSSIE'S ROMAN SHMALTZ HERRING
- OSSIE'S PICKLED HERRING
- OSSIE'S PICKLED HERRING CLEAR
- OSSIE'S PICKLED LOX
- Glipizide 2
- Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle
- Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx…
- Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-0…
- Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06…
- Tortilla Crusted Crumb is a breading system
- Golden Dipt¿ Jalape¿o Breader is in a white 10 pound bag with the UPC number 7630897215…
- SOUTHWEST BREADER G2293 25 LB BAG POLY BAG ITEM G2293
- Bulk flour bland breader packaged into 15, 30, and 50 lb bags or boxes
- Coconut milk , 13
- Al Rasheed Sardine Item #4017 Label not available - NYSDAM sampling
- Sun Life Natural Sunflower Kernel Paste
- Sun Life Enjoy Life Sunflower Spread
- Sun Life Natural Sunflower Spread in clear plastic jar with brown plastic lid
- Sun Life Natural Sunflower Spread with Maple in clear plastic jar with brown plastic lid
- Sun Life Natural Sunflower Spread with Chocolate in clear plastic jar with brown plasti…
- Summer Vegetable Salad with Seared Chicken, Garlic Croutons, and Mustard-Chive Vinaigrette
- Lemony Pan-Seared Chicken with Pesto Potato Salad and Peas
- Seared Steak with Spring Veggie Succotash and Mint-Chive Pesto
- Nir's Lamb-Stuffed Zucchini with Spiced Lentil Stew
- Domino PURE CANE LARGE GRAIN GRANULATED SUGAR
- Haitai Matdongsan Peanuts Crunch Snack
- IQF 1/4" Yellow Onion Dice, frozen, item numbers: 103364, 103381, and 104831, bulk cases
- IQF 3/8" Yellow Onion Strip, Frozen, Item number 103331, bulk tote
- IQF 3/8" Un-Blanched Yellow Onion Dice, Frozen, item number 103349, bulk cases
- IQF 3/4" Yellow Onion Dice, Frozen, item number 101430, bulk tote
- IQF 1/4" Frozen WHITE Onion Dice, item number 103342, bulk cases
- 3/8" White Onion Dice- FRESH, item number 105197, bulk tote
- 3/8" White Onion Strip-FRESH, item number 105196, bulk totes
- IQF 1/4 x 1/4 Yellow Onion Dice, item number 102654, bulk cases
- 705000 IQF 3/8" Dice Yellow Onion, item number 101472, bulk tote
- Label reads in part as: "Maga***BACALAITOS CODFISH FRITTER MIX***Peso Neto/Net Weight 4
- Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by…
- Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP
- Healthwise, Protein Chips, Barbecue Crunch
- Cafe Favorites Turkey Ham, Egg & Cheese Sunrise Twist Code #C51140/51140
- Cafe Favorites Turkey Ham & Cheese Deli Flatz Code #C22148/22148
- Integrated Food Service Turkey Ham & Cheese Sandwich Code #C13001/130001
- Cafe Favorites Turkey Ham & Cheese Melt on a Knot Roll Code #C02172/02172
- Cafe Favorites Turkey Ham & Cheese Submarine Code #C02184/02184
- Cafe Favorites Oven Roasted Turkey Breast & Cheese Melt on Knot Roll Code #C02272/02272
- Cafe Favorites Oven Roasted Turkey Breast Sub Code #C02284/02284
- Cafe Favorites Cold Cut Combo on a Whole Grain Knot Roll Code #C02372/02372
- Cafe Favorites 5" Super Sub on a Whole Grain Hoagie-IW Code #C02384/02384
- Integrated Food Service Turkey Bologna & Cheese Sandwich Turkey Bologna on a whole Gr…
- Integrated Food Service Turkey Ham & Cheese Sandwich on a Whole Grain Knot Roll Cod…
- Integrated Food Service Turkey Ham & Cheese Sandwich on a Whole Grain Hawaiian Bun…
- Integrated Food Service Submarine on a French Roll Turkey Bolo, Turkey Salami and Che…
- Integrated Food Service Italian Submarine Sandwich Code #C140004/C14004
- Integrated Food Service Submarine Sandwich on a Whole Grain Ciabatta Roll Code #C1400…
- Integrated Food Service Turkey Breast Combo on a Whole Grain Knot Roll Code #C15008/1…
- Integrated Food Service Turkey Breast & Cheese Sandwich on a Whole Grain French Roll…
- Integrated Food Service Turkey Breast & Cheese Sandwich on a Whole Grain Ciabatta Rol…
- Cafe Favorites Oven Roasted Turkey Breast & Cheese Deli Flatz-IW Code #C22348/22348
- Cafe Favorites Italian Deli Flatz Code #C22548/22548
- Integrated Food Service Chicken Patty Sandwich Chicken Patty on a Whole Grain Bun Co…
- Integrated Food Service BBQ Rib Sandwich BBQ Rib Beef Patty on a Whole Grain Roll Co…
- Integrated Food Service All America Burger Beef Patty on a Whole Grain Bun Code #470007
- Integrated Food Service Cheeseburger Sliders Mini Slider Beef Patty and Cheese on a W…
- Integrated Food Service All American Cheese Burger Beef Patty and Cheese on a Whole G…
- Integrated Food Service Teriyaki Burger Beef Patty on a Whole Grain Hawaiian Bun Cod…
- Cafe Favorites Turkey Sausage & Cheese Sunrise Twist Code #C52140/52140
- Integrated Food Service Turkey Sausage & Cheese Bagel Thin Sandwich Code #809013
- Integrated Food Service Beef Sausage & Cheese on a Mini Bagel Code #809016/C80916-CH…
- Integrated Food Service Chicken Double Dogs on Whole Grain Buns Code #809021
- Integrated Food Service Chili Cheese Dog on Whole Grain Buns Code #809022
- Integrated Food Service Chicken Little Sliders-Wrapped Code #809050
- Integrated Food Service Bean & Cheese Chalupa-Bulk Code #C82705/827005
- Integrated Food Service Chicken Hot Dog on a Whole Grain Bun Code #941500
- Integrated Food Service Chili Cheese Dog Whole Grain Hot Dog Bun, Chicken Frank, Chil…
- Integrated Food Service Low Sodium, Reduced Fat Chili Cheese Dog Chicken Hot Dog wi…
- Integrated Food Service Original Wienerschnitzel Chili Cheese Dog All Meat Hot Dog w…
- Integrated Food Service Beef Sausage Sandwich Beef Sausage Patty on a Whole Grain Haw…
- Integrated Food Service Egg & Cheese Bagel Thin Sandwich Code #C38004/380004
- Sundae Shoppe Novelty Ice Cream Dipped "Variety"cones, 32 oz
- Williams Chipotle Chili Seasoning
- Williams Chipotle Taco Seasoning
- Snack Factory Original Pretzel Crisps, Thin, Crunchy Pretzel Crackers
- Raw Refrigerated Cucumbers, 11/9 bushel, 6 count, 12 count, 24 count, in corrugated ca…
- Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution,
- Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray,…
- Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,…
- Lance Oyster Crackers, Dist
- Cherry Cheesecake, 5 oz
- Strawberry Cheesecake, 5 oz
- Blueberry Cheesecake, 5 oz
- Salad topping labeled under the following brand names: (Product 1) Durkee Salad Toppi…
- Macaroni Salad with Cheddar Cheese is packaged in a plastic bag, each case contains 2/5…
- ROAST, NO SALT SUNFLOWER SEEDS sold under the following brands: Jungle Jim 16oz (453G)…
- Windy Acres FRUITY TRAIL MIX Roasted Peanuts, Pineapple, Papaya, Raisins & Almonds 7 OZ…
- Cherokee Rose Hand Made cheese, Produced by Natures Harmony in Berton, GA 30635
- The Fresh Market, Smoked Supreme Nut Mix
- Cumberland Farms Farmhouse Premium Chocolate Treats - Sea Salt Carmel Delights, 3 oz
- Diced and sliced yellow onions
- Meduri Farms Dried Blueberries/Sugar Infused, Catalog #s: 080282, 08028X, 08028, 0802…
- Creative Snacks Brain Food, 3
- Fresh Market Healthy Snackin, 25 lb
- Plentiful Planet Heart Smart Mix, 25 lb
- Creative Snacks Co
- Creative Snacks Co
- Creative Snacks Co
- Creative Snacks Co
- Michael's Naturopathic Programs Cholesterol Metabolism Factors 270 count, 180 count, an…
- Raw Macadamias, 6 oz
- Honey Bunchies Gourmet Honey Bars, 1
- Deli-Food Ancho Chile Powder 50 lb corrugated boxes x 45 each
- Kroger DELUXE ICE CREAM S'MORES 48 FL OZ (1
- Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry La…
- Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only…
- Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactu…
- Oxacillin for Injection, USP, 10 grams per pharmacy bulk package, Buffered - For IV Use…
- mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vi…
- Mix Vegetables, brand JFDA (label in Japanese), frozen
- Broccoli & Cauliflower, brand Wild Oats Organic, frozen
- Peas & Carrots, brand Bybee's Best, frozen
- Asparagus, Corn & Carrots Blend, brand Signature Kitchens, frozen
- Supreme Bean & Carrot Blend, brand VIP, frozen
- Organic Mixed Vegetables with Shelled Edamame, brand Bybee Foods, frozen
- Organic Peas & Pearl Onions, brand Columbia River Organics, frozen
- Red, Green and Yellow Pepper Strips, brand Safeway Kitchens, frozen
- Organic Steamers Roasted Red Potato & Vegetable Medley, brand Bybee Foods, frozen
- Organic Root Medley, brand Organic by Nature, frozen
- Organic Gardener's Blend, brand Columbia River Organics, frozen
- Stir Fry Vegetable, brand Signature Kitchens, frozen, net
- Big House Blend, brand Bybee's, frozen
- Mixed Vegetable, brand Emerald Farms, frozen
- Organic California Harvest, brand Columbia River Organics, frozen
- Stew Vegetables, brand Signature Kitchens, frozen
- Mini Bow Tie Pasta and Vegetable Blend, brand Live Smart, frozen
- Organic Stir-Fry, brand Kirkland Signature, frozen
- Supreme Garden Stir-Fry, brand VIP, frozen
- Supreme Fiesta Blend, brand VIP, frozen
- Harvest Vegetable Blend, brand Signature Kitchens, frozen
- Garden Blend Vegetables, brand O Organic, frozen
- Organic Garden Stir Fry , brand Columbia River Organics, frozen
- Supreme Stir-Fry Sensation, brand VIP, frozen
- Supreme Healthy Garden Blend, brand VIP, frozen
- Organic Potato Medley, brand Columbia River Organics, frozen
- Organic Broccoli & Cheddar Cheese, brand Columbia River Organics, frozen
- Organic Blueberries, Brand Columbia River Organics
- Organic Sweet Cherries, brand Columbia River Organics
- Organic Cranberries, Brand Columbia River Organics
- Organic Peaches, Brand Columbia River Organics
- Organic Raspberries, Columbia River Organics
- Organic Strawberries, Brand Columbia River Organics
- Organic California Broccoli Florets, Brand Bybee Foods
- Organic Butternut Squash, Brand Columbia River Organics
- Diced Carrots, Brand Northwest Growers Select
- Organic Multi-Colored Cauliflower Florets, Brand Organic by Nature
- Cut Corn, Brand Bybee's Best
- Organic Edamame, Brand Columbia River Organics
- Cut Green Beans, Brand Bybee Foods
- Cut Italian Beans, Brand Northwest Growers Select
- Organic Chopped Kale, Brand Bybee Foods
- Organic Diced Leeks, Brand Organic by Nature
- Baby Lima Beans, Brand Parade
- Organic Chopped Onions, Brand Bybee Foods
- Green Peas, Brand Bybee's Best
- Pepper Strips, Brand Signature Kitchens
- Organic Steamers Sweet Potatoes, Brand Bybee Foods
- Chopped Spinach, Brand Bybee Foods Northwest Growers Select
- Brussels Sprouts, Brand O Organic
- GFS Creamy Indulgence NY Style Cheesecake, 68 oz, 12 cut with papers
- GFS Triple White Chocolate Cheesecake, 68 oz, 14 cut with papers
- GFS Fruit Swirl Variety Cheesecake, 68 oz, 12 cut
- GFS Raspberry Lemonade Cheesecake, 68 oz, 14 cut with papers
- GFS Sea Salt Caramel Cheesecake, 68 oz, 14 cut with papers
- GFS Brownie Cheesecake, 54 oz, 12 cut with papers
- Rold Gold Tiny Twists 1 oz
- Rold Gold Honey Wheat Braided 10 oz
- 20 count Baked & Popped Mix packaged as 20 single flexible plastic bags
- 20 count SunChips & Rold Gold Mix packaged as 20 single flexible plastic bags
- 32 count Fun Times mix packaged as 32 single flexible plastic bags
- 30 count Baked and Popped Variety Pack packaged as 30 single flexible plastic bags
- 30 count Home Town Favorite Variety Pack packaged as 30 single flexible plastic bags
- Casey's Bakery, Almond Patties, Traditional Dutch Puff Pastry Filled with Pure Almond P…
- Ice Nuggets, 10 lb plastic bag
- Sunflower Seeds, PLU# 65167
- Sunflower Kernals packaged in a 5
- Harris Teeter Organics Mixed Vegetables, 16oz bags (product labeling not available)
- Harris Teeter Organics Corn, 16oz bags (product labeling not available)
- 7-ELEVEN FRESH TO GO CHOCOLATE CHUNK COOKIE NET WT
- 7-ELEVEN FRESH TO GO OATMEAL RAISIN COOKIE NET WT
- Doritos Spicy Sweet Chili Flavored tortilla chips in 3 1/8 ounce bags
- DF Mavens Chocolate Almond Fudge Frozen Bars
- whole milk yogurt is packaged in a 32 oz
- MaraNatha¿ All Natural Sunflower Seed Butter
- Armour Snackmaker Keebler Animals Crackers, Chocolate Icing with Natural and Artificial…
- Label reads in part as: "EL ISLE¿O***SOFRITO GOURMET CON SAZON Y ACHIOTE***PESO NETO/NE…
- Xtra Immunity Brown Rice Antioxidant Probiotic Extract, a liquid packaged in a 500mL bo…
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