36 loaded recalls on this report date. 3 Class I. 35 ongoing.
Drugs
Class II
Ongoing
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuti...
Firm: Hikma Pharmaceuticals USA INC.
Reason: Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
openFDA source record
Food
Class II
Ongoing
Outshine Fruit Bars Strawberry, 6-Count 2.5 ounce, with UPC 041548610047, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or...
Firm: Dreyer's Grand Ice Cream Inc.
Reason: Foreign object: products may contain glass pieces
openFDA source record
Food
Class II
Ongoing
Outshine Fruit Bar Watermelon, 6-Count 2.5 ounce with UPC 041548413624, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or co...
Firm: Dreyer's Grand Ice Cream Inc.
Reason: Foreign object: products may contain glass pieces
openFDA source record
Food
Class II
Ongoing
Outshine Fruit Bars Grape, 6-Count 2.5 ounce, with UPC 041548244044, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colde...
Firm: Dreyer's Grand Ice Cream Inc.
Reason: Foreign object: products may contain glass pieces
openFDA source record
Food
Class II
Ongoing
Outshine Fruit Bars Black Cherry, 6 Bars, 2.5 ounce, with UPC 041548000121, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) o...
Firm: Dreyer's Grand Ice Cream Inc.
Reason: Foreign object: products may contain glass pieces
openFDA source record
Devices
Class II
Ongoing
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Firm: Olympus Corporation of the Americas
Reason: Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
openFDA source record
Food
Class II
Ongoing
Marketside Tomato Bisque Soup Kit, Tomato Bisque with Cheese Croutons & White Cheddar Cheese, Ready to Heat, Net Wt. 14 OZ (397g), with UPC 1 94346474004. Must Keep Refri...
Firm: CUISINE, KETTLE
Reason: Product had a presumptive positive test result for Listeria monocytogenes
openFDA source record
Food
Class II
Ongoing
Byron White FORMULAS A-FNG Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95...
Firm: Byron White Formulas, Inc.
Reason: Label does not declare walnuts in English
openFDA source record
Drugs
Class II
Ongoing
Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. In...
Firm: Church & Dwight Co., Inc.
Reason: CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
openFDA source record
Food
Not Yet Classified
Ongoing
Clear glass bottle with black screw lid with multi label which reads in part as "***AFRICANDO FOODS, LLC ALFREDO HOT SAUCE, Net Weight 8 oz. ***INGREDIENTS: Habenaro Pepp...
Firm: Africando Foods LLC
Reason: Labeling, wheat not listed as sub ingredient of chicken bouillon (minor ingredient), and soybean oil missing from ingredient list
openFDA source record
Drugs
Class II
Ongoing
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Ph...
Firm: ACCORD HEALTHCARE, INC.
Reason: Subpotent Drug
openFDA source record
Drugs
Class II
Ongoing
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pha...
Firm: ACCORD HEALTHCARE, INC.
Reason: Subpotent Drug
openFDA source record
Drugs
Class II
Ongoing
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Ph...
Firm: ACCORD HEALTHCARE, INC.
Reason: Subpotent Drug
openFDA source record
Drugs
Class II
Ongoing
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas P...
Firm: ACCORD HEALTHCARE, INC.
Reason: Subpotent Drug
openFDA source record
Drugs
Class II
Ongoing
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured...
Firm: ACCORD HEALTHCARE, INC.
Reason: Subpotent Drug
openFDA source record
Drugs
Class II
Ongoing
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Ph...
Firm: ACCORD HEALTHCARE, INC.
Reason: Subpotent Drug
openFDA source record
Drugs
Class II
Ongoing
Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufacture...
Firm: ACCORD HEALTHCARE, INC.
Reason: Subpotent Drug
openFDA source record
Drugs
Class II
Ongoing
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharm...
Firm: ACCORD HEALTHCARE, INC.
Reason: Subpotent Drug
openFDA source record
Drugs
Class II
Ongoing
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-871...
Firm: Mallinckrodt Hospital Products Inc.
Reason: Presence of particulate matter: glass and stopper piece
openFDA source record
Devices
Class II
Ongoing
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number...
Firm: IMRIS Imaging Inc
Reason: The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to...
openFDA source record
Devices
Class II
Ongoing
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
Firm: IMRIS Imaging Inc
Reason: The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to...
openFDA source record
Food
Class I
Terminated
Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package net wt. 15.4oz. Product is ramen noodle kit which contains noodles and Soba soup pack...
Firm: H & U Inc. dba Sun Noodle
Reason: Soba sauce packet, which contains bonito, sardine, and mackerel (fish), was packed into Sura Tanmen Hot and Sour Flavor ramen noodle package kit, but fish species are not declared on finished product label.
openFDA source record
Devices
Class II
Ongoing
Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration...
Firm: Canon Medical System, USA, INC.
Reason: Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
openFDA source record
Drugs
Class II
Ongoing
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited...
Firm: Lupin Pharmaceuticals Inc.
Reason: Failed content uniformity specifications.
openFDA source record
Food
Class II
Ongoing
ERIDANOUS GREEK STYLE Shortbread Cookies with Chocolate Truffle Coating & Apricot Filling. Product is packed onto a plastic carton tray with outer paper sleeve, 330 g (we...
Firm: Lidl US TRADING
Reason: The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut).
openFDA source record
Food
Class II
Ongoing
ERIDANOUS GREEK STYLE Shortbread Cookies with apricot filling and cocoa topping with coconut sprinkles. Product is packed onto a plastic carton tray with outer paper slee...
Firm: Lidl US TRADING
Reason: The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut).
openFDA source record
Devices
Class II
Ongoing
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Firm: Merge Healthcare, Inc.
Reason: Software issue may cause measurements to be displayed inaccurately.
openFDA source record
Food
Class I
Ongoing
Glutinous Rice Balls with Black Sesame Filling NET WT. 14.1 OZ (400 g) Product of China UPC: 6908791000053
Firm: KHONG GUAN (HQ)
Reason: Undeclared peanuts.
openFDA source record
Devices
Class II
Ongoing
Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON R...
Firm: Medline Industries, LP
Reason: Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs...
openFDA source record
Devices
Class II
Ongoing
Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY, Medline Kit...
Firm: Medline Industries, LP
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
openFDA source record
Devices
Class II
Ongoing
Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ911755; 3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014...
Firm: Medline Industries, LP
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
openFDA source record
Devices
Class II
Ongoing
Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medl...
Firm: Medline Industries, LP
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
openFDA source record
Devices
Class II
Ongoing
Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SK...
Firm: Medline Industries, LP
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
openFDA source record
Devices
Class II
Ongoing
Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40...
Firm: Medline Industries, LP
Reason: Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neuros...
openFDA source record
Devices
Class II
Ongoing
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Firm: Fresenius Medical Care Renal Therapies Group, LLC
Reason: Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.
openFDA source record
Food
Class I
Ongoing
Addall XR Shot 1 single bottle, 2 fl. oz., liquid dietary supplement
Firm: ZMB Enterprises
Reason: The product contains 1,4-DMAA, Phenylethylamine and Phenibut.
openFDA source record