Skip to main content
High RiskFDA
Zimmer, Inc.
Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a component of the Endi...
Medical Devices·14 affected·Aug 26, 2013
High RiskFDA
Ge Healthcare It
Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation ...
Medical Implants·28 affected·Aug 26, 2013
High RiskFDA
Jcb Labs Llc
Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Free/Sulfite Free, 1-mL Single-Use Syringe, Sterile Solution Fo...
Injectable Drugs·1,243 affected·Aug 23, 2013
High RiskFDA
Wellness Pharmacy, Inc.
Dexpanthenol 250 mg/mL PF, Single Use Vial, 1 mL, WELLNESS PHARMACY, 1-800-227-2627
Drugs·1,355 affected·Aug 23, 2013
High RiskFDA
Walgreens Co
Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, Inject 1 mL Intramuscularly as directed by physician, Walgreen...
Injectable Drugs·298 affected·Aug 23, 2013
High RiskFDA
Creative Compounds
Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.
Injectable Drugs·16 affected·Aug 23, 2013
High RiskFDA
Jcb Labs Llc
Sodium Thiosulfate 25%, 250 mg/mL (12.5 g/50mL), PF Sterile Solution for Injection, 50 mL Single Dose Vial, For Office Use Only, JCB Labo...
Injectable Drugs·1,056 affected·Aug 23, 2013
High RiskFDA
South Coast Specialty Compounding, Inc.
Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Multiple Dose Vial, For Slow IV Administration After D...
Injectable Drugs·82 affected·Aug 23, 2013
High RiskFDA
Central Shared Services Dba Parallon
CHILDREN'S IBUPROFEN, ORAL SUSPENSION, 200 mg/10mL cup BERRY FLAVOR, ALCOHOL FREE, MFG: ACTAVIS, PGK BY SAFECOR Columbus, OH
Oral Drugs·3,764 affected·Aug 23, 2013
High RiskFDA
South Coast Specialty Compounding, Inc.
Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA
Injectable Drugs·297 affected·Aug 23, 2013
High RiskFDA
Jcb Labs Llc
Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile Solution For Office Use Only, J...
Injectable Drugs·903 affected·Aug 23, 2013
High RiskFDA
Medaus, Inc.
Magnesium Chl 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183
Drugs·1,880 affected·Aug 23, 2013
High RiskFDA
Wellness Pharmacy, Inc.
Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627
Drugs·1,355 affected·Aug 23, 2013
High RiskFDA
Wellness Pharmacy, Inc.
RL Glutathione 100 mg/mL, SDV PF,a) 1 mL, b) 2 mL, c) 3 mL, and d) 4 mL, WELLNESS PHARMACY, 1-800-227-2627
Drugs·34 affected·Aug 23, 2013
High RiskFDA
Medaus, Inc.
Taurine 50 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183
Drugs·1,660 affected·Aug 23, 2013
High RiskFDA
Jcb Labs Llc
Sodium Citrate 4% containing Gentamicin 320 mcg/mL, Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution For Office Use Only, ...
Injectable Drugs·397 affected·Aug 23, 2013
High RiskFDA
Wellness Pharmacy, Inc.
Magnesium Sulfate Hepta 50% PF, Single Use Vial, a) 2 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627
Drugs·590 affected·Aug 23, 2013
High RiskFDA
Medaus, Inc.
Pyridoxine HCL 100 mg/mL NS (PF), 30 mL, Medaus Pharmacy 1-800-526-9183
Drugs·2,970 affected·Aug 23, 2013
High RiskFDA
Wellness Pharmacy, Inc.
Methyl B12 1 mg/mL P.F., Single-Use Vial, a) 1 mL, b) 10 mL, WELLNESS PHARMACY, 1-800-227-2627
Drugs·2,687 affected·Aug 23, 2013
High RiskFDA
South Coast Specialty Compounding, Inc.
Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA
Injectable Drugs·117 affected·Aug 23, 2013
High RiskFDA
Medaus, Inc.
L-Glutathione 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183
Drugs·6,130 affected·Aug 23, 2013
High RiskFDA
Wellness Pharmacy, Inc.
NA. Phenylbutyrate 200 mg/mL, SDV, a) 10 mL, b) 25 mL, and c) 50 mL, WELLNESS PHARMACY, 1-800-227-2627
Drugs·200 affected·Aug 23, 2013
High RiskFDA
Medaus, Inc.
NA Ascorbate 500 mg/mL, PF, 100 mL, Medaus Pharmacy 1-800-526-9183
Drugs·15,500 affected·Aug 23, 2013
High RiskFDA
Medaus, Inc.
Lipo-Injection w/ Lidocaine (PF), Ascorbic Acid 50 mg; B1-50 mg; B2-5-PO4-5 mg; B3-50 mg; B5-5 mg; B6-5 mg; Cyano B12-100 mcg; Methionine...
Injectable Drugs·19,803 affected·Aug 23, 2013
High RiskFDA
Jcb Labs Llc
Sodium Citrate 4% Solution for Injection, 30 mL Multi Dose Vial, Sterile Solution for Office Use Only, JCB Laboratories, Wichita, KS.
Injectable Drugs·677 affected·Aug 23, 2013
High RiskFDA
Medaus, Inc.
Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-800-526-9183
Drugs·1,198 affected·Aug 23, 2013
High RiskFDA
Medaus, Inc.
NA Ascorbate 500 mg/mL, non corn PF, 100ML, Medaus Pharmacy, 1-800-526-9183
Drugs·8,750 affected·Aug 23, 2013
High RiskFDA
Medtronic Xomed, Inc.
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Medical Implants·60 affected·Aug 23, 2013
High RiskFDA
Schafer Fisheries
Label reads in part: TWIN FIN DELI; Gefilte Fish; Kosher Fish Products Inc., Fulton, IL. FDA# 1481764; Net WT. 24 OZ (680G)
Seafood·250 affected·Aug 22, 2013
High RiskFDA
Ann's House Of Nuts, Inc
Daily Chef, Tropical Fruit & Nut Blend, 44oz plastic bags, Distributed by SAMs West, Inc., Bentonville, AR 72716.
Produce·1,706 affected·Aug 22, 2013
High RiskFDA
Schafer Fisheries
Label reads in part: TWIN FIN DELI; Salami; Net WT. 1lb (453g); P.O. Box 399 Thomson IL, FDA# 1481764 Thomason
Food·398 affected·Aug 22, 2013
High RiskFDA
Schafer Fisheries
*** 1) Fish hot dogs total 1 lb in weight vacuum packaged in plastic bags; Label reads in part: TWIN FIN DELI; Franks; Net WT. 1lb (453g)...
Seafood·0 affected·Aug 22, 2013
High RiskFDA
Ebi, Llc
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and ...
Medical Devices·7,092 affected·Aug 22, 2013
High RiskFDA
Itc-nexus Dx
Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. ...
Medical Devices·6 affected·Aug 22, 2013
High RiskFDA
Biomet Spine, Llc
Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used...
Surgical Devices·14 affected·Aug 22, 2013
High RiskFDA
Biomet Spine, Llc
Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills ...
Medical Devices·15 affected·Aug 22, 2013
High RiskFDA
Aso, Llc
SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
Medical Devices·37 affected·Aug 21, 2013
High RiskFDA
Lucy's Kitchen, Inc.
"***SUPERBUDIN"
Food·150 affected·Aug 20, 2013
High RiskFDA
Lucy's Kitchen, Inc.
"***SUPERPAN***Tu Pan Natural***"
Food·6,985 affected·Aug 20, 2013
High RiskFDA
Industrias Alimenticias Kern's Y Cia. S.c.a.
Ducal Brand Prepared Sauce Queso/Cheese, UPC 088313-08328-6, Net Wt 4 oz, Product of Guatemala, C.A. Central American product made with q...
Dairy·84 affected·Aug 20, 2013
High RiskFDA
Mothers Milk Bank
Human breast milk, pasteurized, 4 oz, in bottles; Pasteurized Human Milk,Hospital Grade Milk. Mother's Milk Bank 751 S. Bascom Abe.S...
Dairy·70 affected·Aug 20, 2013
High RiskFDA
Carestream Health Inc.
Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system ...
Diagnostic Devices·4 affected·Aug 20, 2013
High RiskFDA
Iba Dosimetry Gmbh
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
Medical Devices·33 affected·Aug 20, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Diabetes Devices·36,332 affected·Aug 19, 2013
High RiskFDA
Lumenis, Inc.
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Medical Devices·3 affected·Aug 19, 2013
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc.
Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured ...
Oral Drugs·895 affected·Aug 17, 2013
High RiskFDA
Jean's Cake
Coffee Cake: queso/manzana (cheese/apple)
Dairy·0 affected·Aug 16, 2013
High RiskFDA
Jean's Cake
Coffee Cake: queso crema (creme cheese)
Dairy·0 affected·Aug 16, 2013