FDA recalls, August 2018: 293 published

110 different companies appear this month.

Risk classification: Class I: 30 · Class II: 213 · Class III: 50

Same month, other agencies:CPSC 25 recallsFSIS 9 recallsNHTSA 97 recalls

Recalls this month

DateProduct
August 15, 2018CUPCAKE VANILLA, 4.5 OunceF-1735-2018Whole Foods Market Group Inc.
August 15, 2018Lateral Assembly, Radial Head Implant, Size 3. Orthopedic implant for replacement of the …Z-2672-2018Howmedica Osteonics Corp.
August 15, 201810 mg/mL Rocuronium Bromide (Preservative Free) 5 mL BD Syringe, PharMEDium Services, LLC.D-1045-2018PharMEDium Services, LLC
August 15, 2018Pepperidge Farm Goldfish Baked Snack Crackers, 45 Packs. Containing 15 Flavor Blasted Xt…F-1796-2018Pepperidge Farm, Incorporated
August 15, 2018Vitale Brothers Pumpernickel bread (1lb loaf) UPC1589410008F-1764-2018Vitale Brothers Bakery,Inc.
August 15, 2018AnnaSea Limu Ahi Poke Hawaiian Poke KitsF-1758-2018Aldi Inc
August 15, 2018Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 10…D-1035-2018Baxter Healthcare Corporation
August 15, 2018Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 m…D-1075-2018Mylan Pharmaceuticals Inc.
August 15, 2018115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced Ports¿, T-Con…Z-2650-2018ICU Medical, Inc.
August 15, 2018rHead Recon Stem Implant non-coated, Size 1. Orthopedic implant for replacement of the p…Z-2715-2018Howmedica Osteonics Corp.
August 15, 2018Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured b…D-1074-2018Teva Pharmaceuticals USA
August 15, 2018PARFAIT FRESH FRUIT , 1.0 PoundF-1751-2018Whole Foods Market Group Inc.
August 15, 2018CAKE MOUSSE MANGO 6INF-1746-2018Whole Foods Market Group Inc.
August 15, 2018143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Drop-In …Z-2648-2018ICU Medical, Inc.
August 15, 2018Lateral Assembly, Radial Head Impl Assembly, Size 2. Orthopedic implant for replacement o…Z-2674-2018Howmedica Osteonics Corp.
August 15, 2018Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes. Compounded Guardian Pharmacy Serv…D-1062-2018Guardian Pharmacy Services
August 15, 2018120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock,…Z-2658-2018ICU Medical, Inc.
August 15, 2018132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-W…Z-2646-2018ICU Medical, Inc.
August 15, 2018Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compounded Guard…D-1052-2018Guardian Pharmacy Services
August 15, 2018Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pha…D-1057-2018Guardian Pharmacy Services
August 15, 2018#4 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of t…Z-2713-2018Howmedica Osteonics Corp.
August 15, 2018CUPCAKE BERRY CHANTILLY MEDIUM, 4.5 OunceF-1736-2018Whole Foods Market Group Inc.
August 15, 2018116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿, 2 Ext, Rota…Z-2657-2018ICU Medical, Inc.
August 15, 2018CAKE TOASTED ALMOND 6 IN, 29.6 Ounce CAKE TOASTED ALMOND 9IN, 64.0 OunceF-1742-2018Whole Foods Market Group Inc.
August 15, 2018CAKE LEMON RASPBERRYF-1745-2018Whole Foods Market Group Inc.
August 15, 2018Grizzlies Brand and Grizzlies Granolas Oregon Trail Mix consisting of chocolate chips, fr…F-1759-2018Green Valley Group, LLC
August 15, 2018Genestra brand AFA-gen capsule 15 mg Niacin/ capsule 300 mg Blue Green Algae / capsule …F-1756-2018Seroyal International, a division of Atrium Innovations
August 15, 2018Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pha…D-1066-2018Guardian Pharmacy Services
August 15, 2018Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuti…D-1037-2018NuCare Pharmaceuticals Inc
August 15, 201899" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, St…Z-2626-2018ICU Medical, Inc.
August 15, 2018CAKE BLUEBERRY LEMON 6 INF-1739-2018Whole Foods Market Group Inc.
August 15, 2018Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian P…D-1061-2018Guardian Pharmacy Services
August 15, 201810 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL I…D-1043-2018PharMEDium Services, LLC
August 15, 2018Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounded Guardian P…D-1070-2018Guardian Pharmacy Services
August 15, 2018radial stem implant #3 (Sterile packed). Orthopedic implant for replacement of the proxi…Z-2729-2018Howmedica Osteonics Corp.
August 15, 2018Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV vials. Compounded Guardian P…D-1056-2018Guardian Pharmacy Services
August 15, 2018Lateral Assembly, Radial Head Impl Assembly, Size 4. Orthopedic implant for replacement o…Z-2676-2018Howmedica Osteonics Corp.
August 15, 2018Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal de…D-1041-2018Valeant Pharmaceuticals North America LLC
August 15, 2018Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, 12mL bottle. Distributed…D-1124-2018World Organix, LLC
August 15, 2018Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian …D-1053-2018Guardian Pharmacy Services
August 15, 2018Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grapevine Hwy., H…D-1047-2018Right Value Drug Stores, Inc.
August 15, 2018Vitale Brothers Onion Rolls 16 oz. (6 count per unit) UPC1589410013F-1765-2018Vitale Brothers Bakery,Inc.
August 15, 2018Sweet Earth Foods Aloha BBQ Quesadilla; 2 pack, NET WT 8 oz. Vegan: Pinto Beans, Red On…F-1834-2018Sweet Earth Inc.
August 15, 2018Swiss Rolls***Brand Name**Swiss Rolls Chocolate (Snack) Cakes, NET WT OZ (g) PKGS***TWIN …F-1817-2018FLOWERS FOODS
August 15, 2018B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian Phar…D-1054-2018Guardian Pharmacy Services
August 15, 2018Matiz Raw Apricot Bar Demi-luna 8.8 ounces bar, packaged in shrink wrap plastic, UPC 8 …F-1754-2018Power Selles Imports dba Culinary Collective
August 15, 2018CAKE MANGO MOUSSE 9INF-1747-2018Whole Foods Market Group Inc.
August 15, 2018rHead Recon Stem Implant 6mm Collar,Size 1. Orthopedic implant for replacement of the pro…Z-2689-2018Howmedica Osteonics Corp.
August 15, 2018Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceutical…D-1039-2018NuCare Pharmaceuticals Inc
August 15, 2018Food Network Kitchen Inspirations Asian Style Sesame Ginger Dressing. 12 oz glass bottle…F-1768-2018KRAFT HEINZ FOODS COMPANY

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