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High RiskFDA
Fagron Compounding Services Llc Dba Fagron Sterile Services
Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC...
Injectable Drugs·1,056 affected·Jun 19, 2017
High RiskFDA
Apace Ky Llc
Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 ---...
Oral Drugs·0 affected·Jun 19, 2017
High RiskFDA
Conmed Corporation
STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT...
Surgical Devices·1,612,440 affected·Jun 19, 2017
High RiskFDA
Leica Microsystems, Inc.
Nussloch GmbH ASP6025 Tissue Processor
Medical Devices·812 affected·Jun 19, 2017
High RiskFDA
New Hope Mills Mfg., Inc.
Cost Plus World Market My Favorite Macadamia Pancake and Waffle Mix, 24 oz. UPC Codes: 496960
Bakery & Grains·1,272 affected·Jun 16, 2017
High RiskFDA
Time-cap Laboratories, Inc.
Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmin...
Oral Drugs·1,980 affected·Jun 16, 2017
High RiskFDA
Alvogen, Inc
Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Broo...
Injectable Drugs·72,575 affected·Jun 16, 2017
High RiskFDA
Alvogen, Inc
Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Broo...
Injectable Drugs·5,100 affected·Jun 16, 2017
High RiskFDA
Alvogen, Inc
Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Broo...
Injectable Drugs·71,825 affected·Jun 16, 2017
High RiskFDA
Keystone Dental Inc
Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for ...
Medical Implants·72 affected·Jun 16, 2017
High RiskFDA
Elevation Brands, Llc
Ians Italian Panko Breadcrumb 9 oz UPC 4951277220
Bakery & Grains·20,425 affected·Jun 15, 2017
High RiskFDA
Hospira A Pfizer Company
8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, ...
Drugs·91,483,150 affected·Jun 15, 2017
High RiskFDA
Hospira A Pfizer Company
Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx ...
Drugs·20,337,650 affected·Jun 15, 2017
High RiskFDA
Tris Pharma Inc.
Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manuf...
Oral Drugs·34,824 affected·Jun 15, 2017
High RiskFDA
Hospira A Pfizer Company
Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-...
Drugs·21,436,700 affected·Jun 15, 2017
High RiskFDA
Hospira A Pfizer Company
Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: ...
Injectable Drugs·15,034,600 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterili...
Medical Devices·32 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·3 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Ster...
Medical Devices·127 affected·Jun 15, 2017
High RiskFDA
Tei Biosciences
PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to...
Medical Devices·4,081 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·5 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Ster...
Medical Devices·127 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Steril...
Medical Devices·5 affected·Jun 15, 2017
High RiskFDA
Custom Assemblies Inc
Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Cu...
Surgical Devices·2,155 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Ster...
Medical Devices·127 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·139 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Steril...
Medical Devices·58 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Ster...
Medical Devices·29 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·78 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Ster...
Medical Devices·17 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Steril...
Medical Devices·55 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·4 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·39 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·1 affected·Jun 15, 2017
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is in...
Medical Devices·3 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Ster...
Medical Devices·32 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterili...
Medical Devices·19 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per case Product Usage: The Vis-U-All High Temperature Steril...
Medical Devices·9 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per case Product Usage: The Vis-U-All High Temperature Steri...
Medical Devices·8 affected·Jun 15, 2017
High RiskFDA
Steris Corporation
Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Steril...
Medical Devices·50 affected·Jun 15, 2017
High RiskFDA
Gomacro, Inc.
go macro MACROBAR, coconut + almond butter + chocolate chips, in the following sizes: 1. Net Wt 0.9 oz / 25 G minbar, UPC 8 53555-00671 ...
Dairy·311,706 affected·Jun 14, 2017
High RiskFDA
Gomacro, Inc.
go macro THRIVE Caramel Coconut bar, Net Wt 1.4 oz / 40 G, UPC 8 53555-00652 8
Snacks & Candy·1,875 affected·Jun 14, 2017
High RiskFDA
Gomacro, Inc.
go macro THRIVE Chocolate, Nuts & Sea Salt bar, Net Wt 1.4 oz / 40 G, UPC 8 53555-00650 4
Snacks & Candy·2,651 affected·Jun 14, 2017
High RiskFDA
Biosense Webster, Inc.
SMARTABLATE RF System Generator
Medical Devices·185 affected·Jun 14, 2017
High RiskFDA
Channel Fish Processing Co. Inc
Channel Brand - Raw Breaded Bay Scallops - Net wt/ 10lb. (4.54 KG)
Bakery & Grains·1,055,006 affected·Jun 13, 2017
High RiskFDA
Channel Fish Processing Co. Inc
ICYBAY - Raw Breaded Scallops 30-40CT/LB - Net Wat 2/5 LBS. (4.54Kg)
Bakery & Grains·1,055,006 affected·Jun 13, 2017
High RiskFDA
Channel Fish Processing Co. Inc
Prima - 4OZ Raw Breaded Haddock Squares - NET WT. 10 lbs. (4.54 KG)
Bakery & Grains·1,055,006 affected·Jun 13, 2017
High RiskFDA
Channel Fish Processing Co. Inc
Deli Tilapia - For Deli Use Only - Breaded Tilapia - Net wt. 10 lbs. (4.54 KG) - Dist. by: Beaver Street Fisheries
Seafood·1,055,006 affected·Jun 13, 2017