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High RiskFDA
Haemonetics Corporation
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Diagnostic Devices·3,933 affected·Apr 26, 2022
High RiskFDA
Daavlin Distributing Company
1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. Models: [1 Ser CX 305...
Medical Devices·216 affected·Apr 26, 2022
High RiskFDA
Sca Pharmaceuticals
Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44
Drugs·30 affected·Apr 25, 2022
High RiskFDA
Sca Pharmaceuticals
Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40
Drugs·120 affected·Apr 25, 2022
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC ...
Oral Drugs·12,003 affected·Apr 25, 2022
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 2...
Oral Drugs·11,136 affected·Apr 25, 2022
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, M...
Oral Drugs·7,044 affected·Apr 25, 2022
High RiskFDA
Sca Pharmaceuticals
Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-02...
Drugs·424 affected·Apr 25, 2022
High RiskFDA
Ge Healthcare, Llc
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
Medical Devices·6,612 affected·Apr 25, 2022
High RiskFDA
Pfizer Inc.
Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 1...
Oral Drugs·2,079 affected·Apr 22, 2022
High RiskFDA
Pfizer Inc.
Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY ...
Oral Drugs·10,304 affected·Apr 22, 2022
High RiskFDA
Pfizer Inc.
Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY ...
Oral Drugs·8,346 affected·Apr 22, 2022
High RiskFDA
Convatec, Inc
SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Medical Devices·600 affected·Apr 22, 2022
High RiskFDA
Olympus Corporation Of The Americas
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duode...
Medical Devices·8 affected·Apr 22, 2022
High RiskFDA
Olympus Corporation Of The Americas
Colonovideoscope Model CF-H180AL
Medical Devices·1 affected·Apr 22, 2022
High RiskFDA
Bard Peripheral Vascular Inc
REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
Surgical Devices·1,460 affected·Apr 22, 2022
High RiskFDA
Ivenix, Inc.
Ivenix Infusion System (IIS)
Medical Devices·1,335 affected·Apr 22, 2022
High RiskFDA
Stradis Healthcare
Surgical Suture Kit
Surgical Devices·7,340 affected·Apr 22, 2022
High RiskFDA
Smith & Nephew Orthopaedics Gmbh
INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
Medical Devices·17 affected·Apr 22, 2022
High RiskFDA
Rebel Creamery
Rebel Pistachio Ice Cream, one pint (473 mL, UPC 8 53149 00821 1, Manufactured by Rebel Creamery LLC, Midway, UT 84049. Keep frozen.
Dairy·58,466 affected·Apr 21, 2022
High RiskFDA
Mckesson Corporation Dba Mckesson Drug Company
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310...
Topical Drugs·81,757 affected·Apr 21, 2022
High RiskFDA
Mckesson Corporation Dba Mckesson Drug Company
Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKes...
Topical Drugs·5,640 affected·Apr 21, 2022
High RiskFDA
Mckesson Corporation Dba Mckesson Drug Company
Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed...
Topical Drugs·13 affected·Apr 21, 2022
High RiskFDA
Mckesson Corporation Dba Mckesson Drug Company
Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Sout...
Topical Drugs·1,176 affected·Apr 21, 2022
High RiskFDA
Mckesson Corporation Dba Mckesson Drug Company
Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only, Manufactured by:...
Topical Drugs·55,440 affected·Apr 21, 2022
High RiskFDA
Torco Race Fuels
TORCO RACING FUELS HAND SANITIZER, Alcohol Antiseptic 80% Topical Solution, Hand Sanitizer Non-Sterile Solution, FDA Approved, 76590-834...
Topical Drugs·127 affected·Apr 21, 2022
High RiskFDA
Baxter Healthcare Corporation
3,65 m Extension Set with Luer-lock Connector
Medical Devices·60 affected·Apr 21, 2022
High RiskFDA
Baxter Healthcare Corporation
15 Liters Drain Bag
Medical Devices·510 affected·Apr 21, 2022
High RiskFDA
Dain Technology, Inc. (subsidiary Of Soundable Health, Inc.)
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
Medical Devices·41 affected·Apr 21, 2022
High RiskFDA
Baxter Healthcare Corporation
APD Drain Manifold
Medical Devices·180 affected·Apr 21, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS
Medical Devices·4,033 affected·Apr 21, 2022
High RiskFDA
Baxter Healthcare Corporation
Locking Cap for PD Catheter Adapter
Surgical Devices·75 affected·Apr 21, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW
Medical Devices·500 affected·Apr 21, 2022
High RiskFDA
Oakworks Inc
PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19
Medical Devices·130 affected·Apr 21, 2022
High RiskFDA
Oakworks Inc
Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS
Medical Devices·109 affected·Apr 21, 2022
High RiskFDA
Baxter Healthcare Corporation
5 Prong Manifold Set (with Luer Connectors)
Medical Devices·180 affected·Apr 21, 2022
High RiskFDA
Elegant Foods, Llc
elegant foods 5# Lemon Curd
Food·2 affected·Apr 20, 2022
High RiskFDA
Wegmans Food Markets, Inc.
Wegmans Food You Feel Good About Lobster Bisque - 16 oz packaged in a 4 x 4 x 3.75" clear plastic tub with a snap on lid.
Seafood·2,064 affected·Apr 20, 2022
High RiskFDA
Ion Beam Applications S.a.
Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other co...
Medical Devices·4 affected·Apr 20, 2022
High RiskFDA
Medtronic Perfusion Systems
Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray...
Surgical Devices·1,236 affected·Apr 20, 2022
High RiskFDA
Olympus Corporation Of The Americas
Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
Medical Devices·4 affected·Apr 20, 2022
High RiskFDA
Turkey Hill, Llc
Chocolate Marshmallow Premium Ice Cream, 48 ounce, Paper Carton and Paper Lid, 6 units per shrink-wrapped pack. Keep Frozen. UPC code: 02...
Dairy·972 affected·Apr 18, 2022
High RiskFDA
Soul Cedar Farm Llc
Zesty Sweet Peppers. Shelf stable product in glass container. Net wt. 8 oz (372 g). The label is read in parts: "***Zesty Sweet Pepper...
Beverages·110 affected·Apr 18, 2022
High RiskFDA
Progenacare
progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM300...
Medical Devices·547 affected·Apr 18, 2022
High RiskFDA
Proterixbio
ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number
Medical Devices·640 affected·Apr 17, 2022
High RiskFDA
Macleods Pharma Usa Inc
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count...
Oral Drugs·3,216 affected·Apr 15, 2022
High RiskFDA
Macleods Pharma Usa Inc
Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MF...
Oral Drugs·12,408 affected·Apr 15, 2022
High RiskFDA
Macleods Pharma Usa Inc
Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-coun...
Oral Drugs·3,288 affected·Apr 15, 2022