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High RiskFDA
Guardian Pharmacy Services
Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 10...
Drugs·4,900 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridgerate. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr...
Drugs·442 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dal...
Drugs·100 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C D...
Drugs·5,000 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Da...
Drugs·100 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX ...
Drugs·40 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 10...
Drugs·20 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX...
Drugs·250 affected·May 17, 2018
High RiskFDA
Lupin Pharmaceuticals Inc.
My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Phar...
Oral Drugs·43,922 affected·May 17, 2018
High RiskFDA
Lupin Pharmaceuticals Inc.
My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactur...
Oral Drugs·43,640 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dalla...
Drugs·60 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dall...
Drugs·100 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dall...
Drugs·20 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dalla...
Drugs·2,600 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dall...
Drugs·25 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dall...
Drugs·3 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Da...
Drugs·60 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Da...
Drugs·300 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 1...
Drugs·2,000 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dalla...
Drugs·2 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Magnesium Sulfate 200 mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste....
Drugs·1,000 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 10...
Drugs·1 affected·May 17, 2018
High RiskFDA
Guardian Pharmacy Services
Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Drugs·250 affected·May 17, 2018
High RiskFDA
Arrow International Inc
Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location info...
Cardiac Devices·2,070 affected·May 17, 2018
High RiskFDA
Arrow International Inc
VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous c...
Cardiac Devices·2,070 affected·May 17, 2018
High RiskFDA
Arrow International Inc
VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous cath...
Cardiac Devices·2,070 affected·May 17, 2018
High RiskFDA
Nature's Only Choice
Nature's Only Choice B17 BITTER RAW APRICOT EXTRACT AMYGDALIN Dietary Supplement 100 Capsules
Supplements·250 affected·May 16, 2018
High RiskFDA
Ideaz Llc
screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b) 5 oz. (141g) tubes, UPC 7 5...
Topical Drugs·820 affected·May 16, 2018
High RiskFDA
Ideaz Llc
screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5; b) 5 oz. (141g) tubes, UPC 7 50...
Topical Drugs·800 affected·May 16, 2018
High RiskFDA
Inopak Ltd
Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ
Drugs·1,345 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedull...
Medical Implants·832 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 Intended to be used as a guide pin for insertion of implant...
Medical Implants·11 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramed...
Medical Implants·2,396 affected·May 16, 2018
High RiskFDA
Abbott Laboratories, Inc
C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the...
Diagnostic Devices·8,037 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intrame...
Medical Implants·1,234 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedull...
Medical Implants·248 affected·May 16, 2018
High RiskFDA
Medtronic Inc.
Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless bl...
Diabetes Devices·2 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intr...
Medical Implants·449 affected·May 16, 2018
High RiskFDA
Abbott Laboratories, Inc
Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M in human serum or plasma. Antige...
Diagnostic Devices·9,586 affected·May 16, 2018
High RiskFDA
Abbott Laboratories, Inc
Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Anti...
Diagnostic Devices·2,112 affected·May 16, 2018
High RiskFDA
Ceterix Orthopedics, Inc.
Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.
Medical Devices·96 affected·May 16, 2018
High RiskFDA
Abbott Laboratories, Inc
Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antige...
Diagnostic Devices·12,995 affected·May 16, 2018
High RiskFDA
Abbott Laboratories, Inc
Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma. Antige...
Diagnostic Devices·11,063 affected·May 16, 2018
High RiskFDA
Abbott Laboratories, Inc
Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibo...
Diagnostic Devices·2,273 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intrame...
Medical Implants·34 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramed...
Medical Implants·2,168 affected·May 16, 2018
High RiskFDA
Zimmer Biomet, Inc.
DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intrame...
Medical Implants·10 affected·May 16, 2018
High RiskFDA
R F A Inc.
Frozen Natural Tilapia + Belly V-Pack, Farm Raised Tilapia, Product of Costa Rica, Packed for Osamu Corporation Carson, California 90810
Frozen Food·260 affected·May 15, 2018