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High RiskFDA
Akorn, Inc.
Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Injectable Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031...
Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 15 mL bottles, Rx Only, Sterile, Distributed by: Akorn Operating Company LLC, Gurn...
Ophthalmic Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ...
Oral Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Olopatadine HCl Nasal Spray, 665 mcg, 30.5 g bottles, Rx Only, Manufactured by: Akorn, Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Inhaled / Nasal Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs
Ophthalmic Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles, Manufactured by: HI-TECH PHARMACAL CO., INC., Amiy. ALL NDCs
Inhaled / Nasal Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Granisetron HCl Injection, USP, 1 mg/mL, packaged in a) 1mL and b) 4 mL vials, Rx Only, For Intravenous Use Only, Manufactured by: Akorn,...
Injectable Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Midazolam Injection, USP 2mg/2mL (1 mg/mL) For Intramuscular or Intravenous Use Only, 2mL vials, Rx Only, Manufactured by: Akorn, Inc., L...
Injectable Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Lidocaine Ointment USP, 5%, 1 1/4 oz tubes, Rx Only, Manufactured for: HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. ALL NDCs
Topical Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Midazolam Injection, USP, 50 mg/10mL (5mg/mL), For Intramuscular or Intravenous Use Only, 10 mL vials, Rx Only, Manufactured by: Akorn, I...
Injectable Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, ...
Topical Drugs·0 affected·Apr 26, 2023
High RiskFDA
Akorn, Inc.
Timolol Maleate Ophthalmic Solution, USP 0.5%, packaged in a) 2.5mL bottles, b) 5mL bottles, c) 10 mL bottles, and d)15mL bottles, Rx onl...
Ophthalmic Drugs·0 affected·Apr 26, 2023
High RiskFDA
Garden Highway Southwest, Llc (ghsw, Llc)
Turkey and Havarti Sandwich Net Wt 8.55 oz (242g) UPC 826766155842 packaged in plastic clamshell container
Meat & Poultry·16,866 affected·Apr 25, 2023
High RiskFDA
Zb Importing Llc
Ziyad cinnamon powder, retail 4.5oz plastic jar with shaker cap UPC 074265007432, 12 retail jars per wholesale case
Food·3,456 affected·Apr 25, 2023
High RiskFDA
American Outdoor Products, Inc.
Backpacker s Pantry Blueberry Peach Crisp, 4.6-ounce, packaged in a pouch, UPC-048143026143
Produce·61,101 affected·Apr 25, 2023
High RiskFDA
Linkbio Corp.
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revisio...
Medical Devices·11 affected·Apr 25, 2023
High RiskFDA
Davol, Inc.
Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning sy...
Medical Devices·169 affected·Apr 25, 2023
CriticalFDA
Biofire Diagnostics, Llc
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Medical Devices·61,069 affected·Apr 25, 2023
High RiskFDA
Lumiradx
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566...
Medical Devices·1,003 affected·Apr 25, 2023
High RiskFDA
Davol, Inc.
Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning sy...
Medical Devices·0 affected·Apr 25, 2023
High RiskFDA
Philips North America
Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
Medical Devices·20 affected·Apr 25, 2023
RecallFDA
Origami Catering, Llc
Wakame Seaweed Salad, ready to eat product. Net Weight: 4.5oz 127g. UPC 8 51016 00235 5. Label Ingredients declares: Seaweed (Wakame), A...
Produce·159 affected·Apr 24, 2023
High RiskFDA
Gh Foods Llc
The Traveler's Best Ham & Swiss on Pretzel Roll Smoked Ham and Swiss Cheese With Lettuce and Dijon Mustard on a Pretzel Roll Ingredients:...
Dairy·1,805 affected·Apr 24, 2023
High RiskFDA
Real Greek Llc
The Vanilla Bean Greek Yogurt 4oz cup is part of the 12-Pack case, Ellenos Greek Yogurt, Grade A Milk, Costco Item Code: # 1340833. Th...
Dairy·4,016 affected·Apr 24, 2023
RecallFDA
The Harvard Drug Group
Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo...
Oral Drugs·3,984 affected·Apr 24, 2023
High RiskFDA
Avanos Medical, Inc.
AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509
Medical Devices·33 affected·Apr 24, 2023
RecallFDA
Abbott Ireland Limited
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Diagnostic Devices·110 affected·Apr 24, 2023
High RiskFDA
Avanos Medical, Inc.
SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537
Medical Devices·45 affected·Apr 24, 2023
High RiskFDA
Windstone Medical Packaging, Inc.
Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Medical Devices·60 affected·Apr 24, 2023
High RiskFDA
Avanos Medical, Inc.
ambIT Cassette Filter Male Luer, Product Code: 220266
Medical Devices·1,155 affected·Apr 24, 2023
High RiskFDA
Kawasho Foods Usa, Inc
Geisha Medium Shrimp; WT 4OZ(113g)
Seafood·14,414 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
Surgical Devices·1,054 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
Surgical Devices·17 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
Surgical Devices·40 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
Surgical Devices·156 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
Surgical Devices·2 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
Surgical Devices·175 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
Surgical Devices·524 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
Surgical Devices·436 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only
Surgical Devices·27 affected·Apr 22, 2023
High RiskFDA
Vital Proteins
Vital Proteins Collagen Peptides, retail 24oz plastic canister, UPC 8 57273 00866 6; 6 retail units per wholesale case
Food·59,701 affected·Apr 21, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) ...
Medical Devices·342 affected·Apr 21, 2023
High RiskFDA
Masimo Corporation
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
Medical Devices·123,745 affected·Apr 21, 2023
High RiskFDA
Masimo Corporation
Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
Medical Devices·138,926 affected·Apr 21, 2023
High RiskFDA
Masimo Corporation
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
Medical Devices·443,799 affected·Apr 21, 2023
CriticalFDA
Euro-pharma
Multiple Vitamin B Capsules, 60 Capsules, Biologically Active Forms of Vitamin B12, Folate, B6. Packaged in bottles under the following ...
Supplements·23,770 affected·Apr 20, 2023
CriticalFDA
Novis Pr, Llc Dba Kramer Novis
G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant, Che...
Inhaled / Nasal Drugs·9,077 affected·Apr 20, 2023