FDA recalls, November 2019: 314 published

81 different companies appear this month.

Risk classification: Class I: 56 · Class II: 243 · Class III: 15

Same month, other agencies:CPSC 18 recallsFSIS 8 recallsNHTSA 70 recalls

Recalls this month

DateProduct
November 13, 2019Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530…Z-0326-2020Zimmer Biomet, Inc.
November 13, 2019S-PHENOL 6% INJ SOLN, Rx Only 10ml glass vial, Red Mountain Compounding Rx.D-0243-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000…Z-0298-2020Zimmer Biomet, Inc.
November 13, 2019S-DEXTROSE 50% MDV SOLN, 50 ML glass vial, RX Only, Red Mountain Compounding RXD-0212-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019S-HYDROXOCOBALAMIN 10MG/ML MDV INJ SOL, 30 ML glass vial, Red Mountain Compounding Rx.D-0230-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019S-HYDROXOCOBALAMIN 1000MCG/ML MDV INJ; packaged in a) 10ML b) 30ML glass vial, Red Mounta…D-0268-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for:…D-0304-2020Lupin Pharmaceuticals Inc.
November 13, 2019S-MANGANESE CHLORIDE 0.1MG/ML MDV SOLN, 10 ML vial, Red Mountain Compounding RxD-0239-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz. (30 mL) …D-0193-2020Basic Reset Inc.
November 13, 2019J. BOS Vending Service Monster Cheeseburger, Net Wt. 7.3 oz individually wrapped in plast…F-0133-2020Pride of Iowa Sandwiches, Inc.
November 13, 2019Frozen Saba Misozuke; (seasoned Mackerel) Product # 51108, Not for Retail 12 pkg/5pc(1.…F-0169-2020Azuma Foods International Inc USA
November 13, 2019PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110 0023470011…Z-0308-2020Zimmer Biomet, Inc.
November 13, 2019S-METHYLCOBALAMIN 25MG/ML MDV INJ; 10ML glass vial, Rx Only, Red Mountain Compounding RXD-0272-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger)D-0174-2020Dr. Reddy's Laboratories, Inc.
November 13, 2019Chipotle Chicken Salad, Tuscan Sun brand, is a ready to eat sandwich. Net wt. 9.3 oz (26…F-0123-2020Jumbo Foods, Inc.
November 13, 2019S-LIDOCAINE HCL 2% INHALATION SOLN SYRINGES, 2ML syringe, Red Mountain Compounding RxD-0233-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019Lemon Dessert Bars packaged under Schwartz Brothers Bakery brand in a 11.6 oz (328g), kra…F-0127-2020Schwartz Brothers Restaurants dba Schwartz Brothers Bakery
November 13, 2019S-METHYLCOBALAMIN 1,000MCG/ML MDV INJ; a) 10ml, b) 30 ml glass vial, Rx Only, Red mountai…D-0240-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019S-TEST CYP/NAN-DECA 200/50MG/ML MDV IN SESAME OIL; Rx Only, 10ml glass vial. Red Mountain…D-0287-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 00877004003 00…Z-0335-2020Zimmer Biomet, Inc.
November 13, 2019S-E2/TEST CYP 0.4MG/1MG/MLMDV IN OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain C…D-0215-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019S-TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL (TEST CYP 200MG/TEST PROP 25MG/NANDROLONE…D-0292-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial. Red Mountain …D-0257-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019Teriyaki Grilled Calamari, (Grilled Squid with Teriyaki Sauce) Product # 51100; not for …F-0167-2020Azuma Foods International Inc USA
November 13, 2019Prismaflex Control Unit, software versions below 7.21Z-0277-2020Baxter Healthcare Corporation
November 13, 2019S-DMPS 50MG/ML INJ SOLN (PF), 5 ml glass vial, Rx Only, Red Mountain Compounding RX.D-0213-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019Prismaflex Control Unit, software versions below 7.21Z-0276-2020Baxter Healthcare Corporation
November 13, 2019CELLECT brand and ESSENTIALS FACTOR Cell Synergy brand Unflavored Powdered Mix Multi-Mine…F-0100-2020Images Unlimited Products, dba Cellect Products
November 13, 2019Prismaflex Control Unit, software versions below 7.21Z-0279-2020Baxter Healthcare Corporation
November 13, 2019Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47235700308…Z-0309-2020Zimmer Biomet, Inc.
November 13, 2019S-METHYLCOBALAMIN 10,000MCG/ML MDV INJ; 30ML glass vial, Rx Only, Red Mountain Compoundin…D-0271-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 6, 2019Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Steri…D-0162-2020Sandoz Inc
November 6, 2019Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL…D-0163-2020Sandoz Inc
November 6, 2019Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M0…Z-0229-2020Stryker Neurovascular
November 6, 2019Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M003…Z-0225-2020Stryker Neurovascular
November 6, 2019Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compound…D-0160-2020Innoveix Pharmaceuticals Inc
November 6, 2019Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (6…D-0320-2020FITOTERAPIA USA, INC
November 6, 2019Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nail…Z-0219-2020OrthoPediatrics Corp
November 6, 2019Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceutical…D-0155-2020Mylan Pharmaceuticals Inc.
November 6, 2019Bulk Dry Apricot in clear plastic bags inside brown cardboard box and Swan brand Dry Appr…F-0128-2020Peekay International, Inc.
November 6, 2019PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose …D-0154-2020Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
November 6, 2019C3 Wave App, v. 2.0.5Z-0222-2020Medical Components, Inc dba MedComp
November 6, 2019Honey Donut (Yahk Gwa), brand name Han Yang, packaged in a white Styrofoam boat wrapped i…F-0076-2020Han Yang Corp.
November 6, 2019Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with dispo…D-0156-2020Glenmark Pharmaceuticals Inc., USA
November 6, 2019TherMax Blood Warmer UnitZ-0247-2020Baxter Healthcare Corporation
November 6, 2019POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follow…Z-0262-2020POM Medical LLC
November 6, 2019Maintenance Flush Kit/Blood Draw Product Code: DT19335Z-0254-2020Centurion Medical Products Corporation
November 6, 2019ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60AZ-0201-2020Ethicon Endo-Surgery Inc
November 6, 2019Jack Daniels Tennessee Whiskey Cake - Chocolate - Net Wt 8 OZ (227 g), UPC: 854621004349F-0079-2020The Great Spirits Baking Company, LLC
November 6, 2019Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore ProgrammerZ-0240-2020Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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