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High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peo...
Injectable Drugs·4 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peo...
Injectable Drugs·35 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Cyclosporin 0.1% Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Drugs·7 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Methylcobalamin 5000 mcg/mL Preservative Free Injection, packaged in a) 4 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 462...
Injectable Drugs·2 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·5 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·5 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 46...
Injectable Drugs·261 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
HCG 1000 U/ LIDO 0.2%/mL Injection, packaged in a) 3 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peor...
Injectable Drugs·2 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Sermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c) 6 mL, or d) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4...
Injectable Drugs·7 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1.2 mL, c) 1.6 mL, d) 2.0 mL, e) 2.4 mL, f) 3.6 mL, g) 4 mL, h) 4.8 mL vials; and ...
Injectable Drugs·21 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e) 6 mL, f) 7.5 mL, g) 8 mL, and h) 9 mL vials, Rx ...
Injectable Drugs·49 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·6 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
LIPO-B Special Injection,12 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·1 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. Universi...
Drugs·2 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria,...
Injectable Drugs·10 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
HCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·1 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
TRIMIX SPECIAL (30 mg-1 mg-10 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Injectable Drugs·1 affected·Sep 3, 2015
High RiskFDA
Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma
Methylcobalamin 30 mg/mL PF Injection, 0.1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61...
Injectable Drugs·30 affected·Sep 3, 2015
High RiskFDA
Synthes (usa) Products Llc
Inserter for Titanium Elastic Nails (TEN), orthopedic device
Medical Devices·1,550 affected·Sep 3, 2015
High RiskFDA
Bausch & Lomb Inc Irb
BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available i...
Medical Devices·99,260 affected·Sep 3, 2015
High RiskFDA
Summit Medical, Inc.
AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation,...
Medical Devices·9 affected·Sep 3, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gase...
Respiratory Devices·30 affected·Sep 3, 2015
High RiskFDA
Baxter Healthcare Corporation
0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, De...
Injectable Drugs·139,104 affected·Sep 2, 2015
High RiskFDA
Conformis, Inc.
ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) ...
Medical Devices·7 affected·Aug 31, 2015
High RiskFDA
Conformis, Inc.
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M...
Medical Devices·348 affected·Aug 31, 2015
High RiskFDA
Pyng Medical Corporation
MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATRespond...
Medical Devices·6,728 affected·Aug 31, 2015
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE o...
Cardiac Devices·0 affected·Aug 31, 2015
High RiskFDA
Ge Healthcare
GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Op...
Diagnostic Devices·756 affected·Aug 31, 2015
High RiskFDA
Conformis, Inc.
ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) ...
Medical Devices·68 affected·Aug 31, 2015
High RiskFDA
Conformis, Inc.
ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) ...
Medical Devices·6 affected·Aug 31, 2015
High RiskFDA
Ge Healthcare
GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.
Diagnostic Devices·55 affected·Aug 31, 2015
High RiskFDA
Elekta, Inc.
XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy ...
Medical Devices·1,440 affected·Aug 31, 2015
High RiskFDA
Ge Healthcare
GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonanc...
Diagnostic Devices·215 affected·Aug 31, 2015
High RiskFDA
Ge Healthcare
GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic im...
Diagnostic Devices·97 affected·Aug 31, 2015
High RiskFDA
Synthes (usa) Products Llc
Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattac...
Medical Devices·105,882 affected·Aug 31, 2015
High RiskFDA
Conformis, Inc.
ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
Medical Devices·0 affected·Aug 31, 2015
High RiskFDA
Conformis, Inc.
ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) ...
Medical Devices·12 affected·Aug 31, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, an...
Medical Devices·79 affected·Aug 31, 2015
High RiskFDA
Ge Healthcare
GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnost...
Diagnostic Devices·350 affected·Aug 31, 2015
High RiskFDA
Conformis, Inc.
ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGH...
Medical Implants·110 affected·Aug 31, 2015
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE ...
Cardiac Devices·355 affected·Aug 31, 2015
High RiskFDA
Materne, North America
GoGo SQueeZ Applesauce, Apple Peach Sweet Potato, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, ...
Food·34,414 affected·Aug 28, 2015
High RiskFDA
Materne, North America
GoGo SQueeZ Applesauce, Apple Mango, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-p...
Food·34,573 affected·Aug 28, 2015
High RiskFDA
Materne, North America
GoGo SQueeZ Applesauce, Apple Grape, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-p...
Food·34,573 affected·Aug 28, 2015
High RiskFDA
Materne, North America
GoGo SQueeZ Applesauce, Berry Pear, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pa...
Produce·34,573 affected·Aug 28, 2015
High RiskFDA
Materne, North America
GoGo SQueeZ Applesauce, Apple Peach Sweet Potato, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, ...
Food·34,573 affected·Aug 28, 2015
High RiskFDA
Materne, North America
GoGo SQueeZ Applesauce, Apple Pear, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pa...
Food·34,573 affected·Aug 28, 2015
High RiskFDA
Materne, North America
GoGo SQueeZ Applesauce, Apple Banana, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-...
Food·34,573 affected·Aug 28, 2015