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FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627 Wellness Pharmacy, Inc. Class II Terminated 20130918
EDTA disodium 150 mg/mL Sterile Injection, 20 mL Multi Dose Vial, Pharmacy Creations, Randolph, NJ 07869 Pharmacy Creations Class II Terminated 20130918
Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph, NJ. Pharmacy Creations Class II Terminated 20130918
Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA South Coast Specialty Compounding, Inc. Class II Terminated 20130918
Multitrace-5 Concentrate (Trace Elements -5 Conc Injection) Solution, Sterile 10mL Multiple Dose Vial, For Slow IV Administration After Dilution Only, Park Compounding, Irvine, CA South Coast Specialty Compounding, Inc. Class II Terminated 20130918
Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA South Coast Specialty Compounding, Inc. Class II Terminated 20130918
PGE-1, 100 mcg/mL Injection in Normal Saline, 50 mL, University Compounding Pharmacy, 855-398-1800. University Compounding Pharmacy Class II Terminated 20130918
PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Pharmacy, 855-398-1800. University Compounding Pharmacy Class II Terminated 20130918
Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800. University Compounding Pharmacy Class II Terminated 20130918
Testosterone CYP (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800. University Compounding Pharmacy Class II Terminated 20130918
Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800. University Compounding Pharmacy Class II Terminated 20130918
Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070. Creative Compounds Class II Terminated 20130918
MANGANESE SULFATE 0.1 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
CALCIUM EDTA 300 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
CALCIUM EDTA 200 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
BUPRENORPHINE 0.1/0.05 MG/ML CREAM, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
B-12 REJUV 25 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
ASCORBIC ACID (CORN SOURCE) 500 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
ALPROSTADIL 100 MCG/ML INJ SOLN, all sizes, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
Zinc Sulfate 1 mg/ml INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
VITAMIN D 50,000 I.U./ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
VITAMIN B-COMPLEX INJECTABLE, VITAMIN B-COMPLEX SL SOLN and VITAMIN B-COMPLEX (PF) INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
TRIPTROPIN PLUS INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
TRIPLE-TESTOSTERONE 250 MG/ML OIL INJ SOLN and TRIPLE-TESTOSTERONE 200 MG/ML OIL INJ SOLN, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
TRIAMCINOLONE ACETONIDE 80 MG/ML INJ SUSP, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
TRI-MIX 10 MCG/30 MG/1 MG/ML INJ SOLN and TRI-MIX 30 MCG/15 MG/2 MG/ML INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
TESTOSTERONE PROPIONATE 100 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
TESTOSTERONE CYPIONATE 100 MG/ML, 200 MG/ML, 20 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
SODIUM PHOSPHATE MONOBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI Beacon Hill Medical Pharmacy, P.C. Class II Terminated 20130918
Velextra All-Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 & 12 capsule bottles, Manufactured For: BeaMonstar Products Queen Creek, AZ Beamonstar Products Class I Terminated 20130911
SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles, Manufactured For: BeaMonstar Products, Queen Creek, AZ Beamonstar Products Class I Terminated 20130911
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11 Teva Pharmaceuticals USA, Inc. Class II Terminated 20130911
Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12 Hospira Inc. Class II Terminated 20130904
Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01 Hospira, Inc. Class II Terminated 20130904
Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals Inc, Lincolnshire, IL 60069, NDC 14789-300-02 Nexus Pharmaceuticals Inc Class II Terminated 20130904
Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-467-03 Teva Pharmaceuticals USA, Inc. Class II Terminated 20130904
Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges per box - 1.7 mL minimum each, NDC #s: a) Octocaine 100, Mfr'ed for Septodont, Louisville, CO, 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3, 0362-9023-05; b) Superdent, Dist by: Darby Dental Supply Co., Jericho, NY 11753, Made in Canada, 66467-9730-5; and c) Dist by: IQ Dental, 353 Rt 46 W, Bldg C Unit 120, Fairfield, NJ, 07004, made in Canada, 42756-1030-5; Manufactured by: by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3. Novocol Pharmaceutical of Canada Class II Terminated 20130904
0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23 Hospira Inc. Class I Terminated 20130904
Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York Bethel Nutritional Consulting, Inc Class I Terminated 20130904
Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50 Fresenius Kabi USA, LLC Class I Terminated 20130904
ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9. Advance Pharmaceutical Inc Class I Terminated 20130904
Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA Clinical Specialties Compounding Pharmacy Class II Terminated 20130904
buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6. Actavis South Atlantic LLC Class III Terminated 20130904
CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised of: Daily Care Foaming Cleanser (Salicylic Acid 2%) NDC 62032-111; Pore Therapy (Salicylic Acid 2%) NDC 62032-110 and Therapeutic Lotion (Benzoyl Peroxide 5%) NDC 562032-113). Product under recall is the Pore Therapy (Salicylic Acid 2%), NDC 62032-110. Medicis Pharmaceutical Corp Class II Terminated 20130828
IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7. Fresenius Kabi USA LLC (FK USA) Class II Terminated 20130828
Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53 Bracco Diagnostics Inc Class III Terminated 20130828
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771 VistaPharm, Inc. Class II Terminated 20130828
Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR Earthlabs, Inc. DBA Wise Woman Herbals Class II Terminated 20130828