FDA recalls: September 2017
Every food and drug recall report the FDA published in September 2017: 169 reports, 43 of them Class I.
- Recall reports
- 169
- Class I (serious)
- 43
- Food
- 117
- Drugs
- 52
- Sep 27, 2017Quillivant XR methylphenidate HCl, for extended-release oral suspension, 600 mg/120 mL…Drug · Pfizer Inc.Failed Dissolution SpecificationsClass III
- Sep 27, 2017Quillivant XR methylphenidate HCl, for extended-release oral suspension, 750mg/150 mL t…Drug · Pfizer Inc.Failed Dissolution SpecificationsClass III
- Sep 27, 2017Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total…Drug · PharMedium Services, LlcLabeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.Class II
- Sep 27, 2017Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100 mL total…Drug · PharMedium Services, LlcLabeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.Class II
- Sep 27, 2017HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of…Drug · Pfizer Inc.Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.Class II
- Sep 27, 2017Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5…Drug · Pfizer Inc.Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.Class II
- Sep 27, 2017Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1Drug · Noven Pharmaceuticals, Inc.Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.Class II
- Sep 27, 2017Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2Drug · Noven Pharmaceuticals, Inc.Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.Class II
- Sep 27, 2017Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3Drug · Noven Pharmaceuticals, Inc.Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.Class II
- Sep 27, 2017Daytrana (methylphenidate transdermal system) Delivers 15 mg over 9 hours (1Drug · Noven Pharmaceuticals, Inc.Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.Class II
- Procrit (epoetin alfa), 10,000 units/mL, packaged in a) box of 6 single use 1 mL vials…
- Aminocaproic Acid, USP (6-Aminohexanoic Acid) active pharmaceutical ingredient, package…
- Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1 single-…
- Kilby Cream Ice Cream, Almond Delight Size: 7 oz
- Kilby Cream Ice Cream, Birthday Cake Size: 7 oz
- Kilby Cream Ice Cream, Black Cherry Size: 7 oz
- Kilby Cream Ice Cream, Black Raspberry Size: 7 oz
- Kilby Cream Ice Cream, Butter Pecan Size: 7 oz
- Kilby Cream Ice Cream, Calfiene Size: Pint
- Kilby Cream Ice Cream, Cappuccino Size: 2
- Kilby Cream Ice Cream, Cookie Monster Size: 2
- Kilby Cream Ice Cream, Cow Dough Size: 2
- Kilby Cream Ice Cream, Cowconut Size: 2
- Kilby Cream Ice Cream, Crow Vineyard Rose Size: 2
- Kilby Cream Ice Cream, Holstein Cream Size: 2
- Kilby Cream Ice Cream, Independence Explosion Size: 2
- Kilby Cream Ice Cream, Island Breeze Size: 2
- Kilby Cream Ice Cream, Java Chip Size: 2
- Kilby Cream Ice Cream, Jersey Swirl Size: 2
- Kilby Cream Ice Cream, Key Lime Pie Size: 2
- Kilby Cream Ice Cream, Lemon Cheesecake Size: 2
- Kilby Cream Ice Cream, Maryland Madness Size: 2
- Kilby Cream Ice Cream, Mint Mookie Size: 2
- Kilby Cream Ice Cream, Minty Moo Size: 2
- Kilby Cream Ice Cream, Mootella Size: 2
- Kilby Cream Ice Cream, Oriole Chip Size: 2
- Kilby Cream Ice Cream, Peach Size: 2
- Kilby Cream Ice Cream, Pistachio Size: 2
- Kilby Cream Ice Cream Various Flavors: Pretzel Ball Size: 2
- San Francisco Foods Seafood Salad
- Kilby Cream Ice Cream Various Flavors: Ravenberry Size: 2
- Kilby Cream Ice Cream Various Flavors: S'mores Size: 2
- Kilby Cream Ice Cream Various Flavors: Snickers Size: 2
- Kilby Cream Ice Cream Various Flavors: Strawberry Size: 2
- Kilby Cream Ice Cream Various Flavors: Strawberry Cheesecake Size: 2
- Kilby Cream Ice Cream Various Flavors: , Sweet Cream Size: 2
- Kilby Cream Ice Cream Various Flavors: , Tracker Tracks Size: 2
- Kilby Cream Ice Cream Various Flavors: , Vanilla Size: 2
- Kilby Cream Ice Cream Various Flavors: , Vanilla Chip Size: 2
- Dark Chocolate Jete Nutritional Energy Bar, One Mother of a Bar
- Chocolate Jete Nutritional Energy Bar, One Mother of a Bar
- Cranberry Raisin Jete Nutritional Energy Bar, One Mother of a Bar
- Scampi Butter
- Cabernet Grille Butter
- Maradol Papaya
- Honest Kids Juice Slushy Blueberry Punch, 3
- Organic Great Value Dark Sweet Cherry Products Pitted
- Handsome Brook Farm Soy-Free Organic Pasture-Raised Eggs
- Joy's Gourmet Olive Tapenade with Blue Cheese, All Natural
- Joy's Gourmet Pesto, All Natural
- Joy's Gourmet Garlic Joy All Natural Alla Vodka, Sugar Free Gluten Free
- Joy's Gourmet Pesto, All Natural
- Joy's Gourmet Olive Tapenade, All Natural
- Joy's Gourmet Olive Salad, All Natural
- Joy's Gourmet Artichoke Salad, All Natural
- Laxmi Rusks, 10
- El Chilar Whole Ginger
- Organic Coconut Sugar, 16oz bag, 12 bags/case, packed in a foil bag
- Big Win Butter Popcorn, 5 oz
- AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Al…
- Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochloride and phe…
- Doctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephrine hydroch…
- Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Health…
- Vitamin A&D Ointment (petroleum 93
- Hydrocodone Bitartrate and Acetaminophen Oral Solution 7
- Ninjacof (Chlophedianol HCL 12
- Ninjacof-A (Acetaminophen 160 mg, Chlophedianol HCL 12
- ANDROPHARM STEN Z (2, 17a-Dimethyl-17b-hydroxy-5a-androst-1-en-3-one 10mg and 17b-hydro…
- ANDROPHARM M1 ALPHA (Methyl-1-Etiocholenolol-Epietiocholanollone 20 mg) capsule, packag…
- New Kopi Jantan Tradisional Natural Herbs Coffee, packaged in 13 gram red packets, and…
- Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 3…
- PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W
- Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W
- Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W
- G.A.C 25/100/250mg, 30 mL Vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL…
- Calcium chloride 10%, 10 mL vials, Rx only, Bella Pharma 3101 W
- B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W
- Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W
- Magnesium Chloride 200mg, 30m L vials, Rx only, Bella Pharma 3101 W
- L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W
- MIC 25/50/50, 30mL vials, Rx only, Bella Pharma 3101 W
- Lidocaine Ophthalmic Gel 3
- Phenylephrine2
- Sodium Bicarbonate 8
- Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W
- Bevacizumab Prefilled 30g and 31 gram 1
- BevaDex (bevacizumab) 0
- Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharm…
- Rugby Calcionate Syrup, One Pint (473 mL)
- Rugby Cerovite Liquid, 8 oz
- Rugby D 3 Vitamin Liquid, 400 IUI/1 mL, 1 and 2/3 oz
- Rugby Fer-iron Liquid, 1 and 2/3 oz
- Rugby Liquid Vitamin C Supplement, 4 oz
- Rugby Ferrous Sulfate Liquid One Pint, (473 mL)
- Rugby Polyvitamin Liquid, 1 2/3 oz (50 mL)
- Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL)
- Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL)
- Major CertaVite Liquid, 8 oz
- Major D-Vita Drops, 1 2/3 oz (50 mL)
- Major Ferrous Drops, 1 2/3 oz (50 mL)
- Major Poly-Vita Drops, 1 2/3 oz (50 mL)
- Major Poly-Vita Drops with Iron, 1 2/3 oz (50 mL)
- Major Tri-Vita Drops, 1 2/3 oz (50 mL)
- Leader Liquid Multivitamin Supplement for Infants and Toddlers , 1 2/3 oz (50 mL)
- Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL)
- Breaded Fish with Vera Cruz Sauce
- 12" homestyle pizza crusts packed 18 to a case (no consumer packaging) labeled as: Tom…
- Zlotoklos brand Ciastka maslane w czekoladzie (Butter cookies in chocolate), 12
- Wegmans Assorted Muffins 4-Pack-18 oz
- Java Monster Loco Moca Coffee & Energy, Net Wt
- Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for…
- Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-cou…
- Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Manufactured…
- Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow IV Admi…
- Latanoprost PF Solution, 0
- Timolol-Latanoprost PF Solution (0
- Timolol-Brimonidine-Dorzolamide-Latanoprost (0
- Whole Foods Smoked Peppered Atlantic Salmon Portion, packed in bulk boxes
- Whole Foods Smoked Traditional Atlantic Salmon Portion, packed in bulk boxes
- Whole Foods Smoked Whitefish Fillet, packed in bulk boxes
- OPA by Litehouse Ranch, 6/11
- Gazab Green Raisins, 7 oz
- Madhava Naturally Sweet Deliciously Organic MMM
- Southeastern Mills, Biscuit Gravy Mix
- Southeastern Mills, Country Biscuit Mix
- Southeastern Mills, Buttermilk Drop Biscuit Mix
- Southeastern Mills, Easy Drop Cheddar Garlic Drop Biscuit Mix
- Shore Lunch, Fish Breading Batter Mix, Original Breading
- Shore Lunch, Fish Breading Batter Mix, Cajun Style Breading
- Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx…
- Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62
- Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz
- Michele s Toasted Muesli, 16 oz bags, 12 units per case
- Bourbon Street Mix, 157 25 lbs cases and 2,509 one (1) lb bags
- HEALTH WARRIOR CHIA BAR ACAI BERRY NT WT 25 g (
- HEALTH WARRIOR CHIA BAR APPLE CINNAMON NT WT 25 g (
- HEALTH WARRIOR CHIA BAR COCONUT NT WT 25 g (
- HEALTH WARRIOR CHIA BAR DARK CHOCOLATE NT WT 25 g (
- HEALTH WARRIOR CHIA BAR VANILLA ALMOND NT WT 25 g (
- ISS ONE Blueberry Cobbler Flavored Protein Bar NET WT 2
- ISS ONE Salted Caramel Flavored Protein Bar NET WT 2012 oz (60 g) ALLERGY ALERT: This…
- CARLA'S PASTA, INC
- Caribena yellow maradol papaya packed in 35 pound cases
- 4-count boxes of KIND Breakfast Dark Chocolate Cocoa Bars 1
- CORN TREATS CONCENTRATED CARAMEL CORN MIX NET WT 1 LB-6 OZ (22 OZ or 623 g) Manufacture…
- (a) SEVEN SUNDAYS VANILLA CHERRY PECAN MUESLI 12oz
- Amrita Chocolate Maca 15g Protein Bar, 60 gm UPC: 853009004056
- Amrita Dark Chocolate Quinoa 15g Protein Bar, 60gm UPC: 853009004438
- Amrita Sunflower Butter & Jelly 15g Protein Bar, 60gm UPC: 853009004414
- Amrita Chocolate Chip Coconut 15g Protein Bar, 60gm UPC: 853009004391
- Amrita Mango Coconut Energy Bar, 50gm UPC: 853009004018
- Amrita Apricot Strawberry Protein Bar, 50gm UPC :853009004056
- Amrita Pineapple Chia Energy Bar, 50gm UPC: 853009004025
- Amrita Apple Cinnamon Energy Bar, 50gm UPC: 853009004049
- Amrita Cranberry Raisin Energy Bar, 50gm UPC: 853009004032
- German chocolate cakes labeled as Schnucks Bakery Deluxe Petite Cake Chocolate Iced Yellow
- Papayas Maradol cavi, Grown and Packed by: CARICA DE CAMPECHE, DISTRIBUTED BY: AGROSONS…
- Valery Brand Maradol Papayas sold fresh in 35 pound boxes
- Mary's Gone Crackers Original Crackers: Organic, Gluten Free, Non-GMO, Vegan
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