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Compounded Drugs

💊 Drugs • 1,855 recalls

Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011-05.

Mckesson Medical-Surgical Inc. Corporate Office

Class I - Dangerous

CGMP Deviations: products were stored outside the drug label specifications.

Jun 29, 2022 Compounded Drugs Nationwide View Details →

GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.

Mckesson Medical-Surgical Inc. Corporate Office

Class I - Dangerous

CGMP Deviations: products were stored outside the drug label specifications.

Jun 29, 2022 Compounded Drugs Nationwide View Details →

Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.

Mckesson Medical-Surgical Inc. Corporate Office

Class I - Dangerous

CGMP Deviations: products were stored outside the drug label specifications.

Jun 29, 2022 Compounded Drugs Nationwide View Details →

Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.

CIPLA

Class I - Dangerous

Lack of Assurance of Sterility: Complaints received of defective container closure.

Aug 2, 2022 Compounded Drugs Nationwide View Details →

Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0.5 FL OZ) bottle per box, Alcon, a Novartis company, NDC 0065-0085-15.

Mckesson Medical-Surgical Inc. Corporate Office

Class I - Dangerous

CGMP Deviations: products were stored outside the drug label specifications.

Jun 29, 2022 Compounded Drugs Nationwide View Details →

Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.

Mckesson Medical-Surgical Inc. Corporate Office

Class I - Dangerous

CGMP Deviations: products were stored outside the drug label specifications.

Jun 29, 2022 Compounded Drugs Nationwide View Details →

Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per box, Alcon, NDC 0065-1433-02.

Mckesson Medical-Surgical Inc. Corporate Office

Class I - Dangerous

CGMP Deviations: products were stored outside the drug label specifications.

Jun 29, 2022 Compounded Drugs Nationwide View Details →

Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16.

Mckesson Medical-Surgical Inc. Corporate Office

Class I - Dangerous

CGMP Deviations: products were stored outside the drug label specifications.

Jun 29, 2022 Compounded Drugs Nationwide View Details →

Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, packaged as a) Signature Care NDC 21130-871-43 UPC 3 21130-78060 1 Distributed By Better Living Brands LLC P.O. Box 99, Pleasanton, CA 94566-0009; b) Solimo UPC 8 42379 14781 4 Distributed By: Amazon.com Services, Inc. Seattle, WA 98109; c) QC Quality Choice UPC 6 35515 99466 9 Distributed by C.D.M.A., Inc. 43157 W 9 Mile Rd, Novi, MI; d) CVS Health UPC 0 50428 37591 4 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; e) Careone UPC 3 41520 31311 0 Distributed By: Foodhold U.S.A., LLC Landover, MD 20785; f) Market Basket UPC 0 49705 75280 7 Distributed By Demoulas Super Markets, Inc. 875 East Street, Tewksbury, MA 01876; g) Rexall UPC 0 72785 13848 3 Distributed By Old East Main Co. 100 Mission Ridge, Goodlettsville, TN 37072; h) HEB UPC 9 41220 25111 7 Distributed By: HEB San Antonio, TX 78204; i) Core Values UPC 0 79068 00707 8 Distributed by Liberty Procurement Co., Inc. Union, NJ 07083; j) Swan NDC 0869-0871-43 UPC 3 08694 70610 0 Distributed by Vi-Jon One Swan Drive, Smyrna, TN 37167; k) Cariba Care UPC 6 46702 05602 2 Distributed by: Cariba International P.O. Box 1208. Safety Harbor, Florida 34695; l) Kroger UPC 0 11110 79460 4 Distributed By The Kroger Co., Cincinnati, Ohio 45202; m) CVP Health UPC 7 61706 16314 6 Distributed By Salado Sales, Inc. Temple, TX 76503; n) Medline NDC 53329-981-06 UPC 0 80196 74870 2 Made in US with US and foreign components for Medline Industries, Inc., Northfield, IL 60093; o) Exchange Select UPC 6 14299 39968 6 Manufactured For Your Military Exchanges By: Vi-Jon 8515 Page Avenue, St. Louis, MO 63114; p) Premier Value UPC 8 40986 01021 7 Distributed by: Pharmacy Value Alliance LLC 407 East Lancaster Avenue Wayne, PA 19087; q) Publix UPC 0 41415 00973 8 Distributed By Publix Super Markets, Inc. 3300 Publix Corporate Parkway Lakeland, FL 33811; r) Being Well UPC 0 51933 13950 3 Distributed By: Moran Foods, LLC St. Ann, MO 63074; s) Medicare NPN 80016265 UPC 8 39748 00017 7 Manufactured by/Fabrique par: Vi-Jon Inc., Smyna, TN 37167; t) Swan NPN 80035214 UPC 0 72785 11239 1 Manufactured By: Vi-Jon, Inc. St. Louis, MO 63114; u) Equate NPN 80036214 UPC 6 28915 16613 3 Manufactured By: Vi-Jon, Inc. St. Louis, MO 63114; v) Iris UPC 61504-871-43 UPC 0 41512 12940 7 Distributed By: Amerifoods Trading Co. P.O. Box 512377, Los Angeles, CA 90051-0377; w) Equaline NDC 41163-871-43 UPC 0 41163 25134 2 Distributed by Supervalu Inc. Eden Prairie, MN 55344 USA; x) TopCare health UPC 0 36800 26711 4 Distributed By TopCo Associates LLC Elk Grove Village, IL 60007; y) Best Choice UPC 0 70038 20055 0 Distributed By: Valu Merchandisers, Co. 6000 Kansas Ave. Kansas City, KS 66106; z) Walgreens NDC 0363-0871-43 UPC 3 11917 20771 1 Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015; aa) Equate NDC 49035-871-43 UPC 6 81131 11871 2 Distributed By: Walmart, Inc., Bentonville, AR 72716

Vi-Jon

Class I - Dangerous

Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.

Jun 28, 2022 Compounded Drugs Nationwide View Details →

GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

TMC Acquisition LLC

Class I - Dangerous

Lack of Assurance of Sterility

Mar 7, 2022 Compounded Drugs Nationwide View Details →

Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding

TMC Acquisition LLC

Class I - Dangerous

Lack of Assurance of Sterility

Mar 7, 2022 Compounded Drugs Nationwide View Details →

Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding

TMC Acquisition LLC

Class I - Dangerous

Lack of Assurance of Sterility

Mar 7, 2022 Compounded Drugs Nationwide View Details →

Procaine HCL 2% (20mg/mL), 30 ml-vial, Refrigerate, Tailor Made Compounding

TMC Acquisition LLC

Class I - Dangerous

Lack of Assurance of Sterility

Mar 7, 2022 Compounded Drugs Nationwide View Details →

Pentosan Polysulfate Sodium 250mg/mL, 5mL-vial, Room Temperature, Tailor Made Compounding

TMC Acquisition LLC

Class I - Dangerous

Lack of Assurance of Sterility

Mar 7, 2022 Compounded Drugs Nationwide View Details →

Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL, 3mL-vial, Refrigerate, Tailor Made Compounding

TMC Acquisition LLC

Class I - Dangerous

Lack of Assurance of Sterility

Mar 7, 2022 Compounded Drugs Nationwide View Details →

Methionine/Inositol/Choline B12 + Carnitine 10mg/40mg/40mg/1mg/100mg/mL, a) 4mL-vial, b) 10 mL-vial, c) 30mL- vial, Refrigerate, Tailor Made Compounding

TMC Acquisition LLC

Class I - Dangerous

Lack of Assurance of Sterility

Mar 7, 2022 Compounded Drugs Nationwide View Details →

Alpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

TMC Acquisition LLC

Class I - Dangerous

Lack of Assurance of Sterility

Mar 7, 2022 Compounded Drugs Nationwide View Details →

Inositol/Choline B12 + Carnitine 40mg/40mg/1mg/100mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

TMC Acquisition LLC

Class I - Dangerous

Lack of Assurance of Sterility

Mar 7, 2022 Compounded Drugs Nationwide View Details →

Folic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding

TMC Acquisition LLC

Class I - Dangerous

Lack of Assurance of Sterility

Mar 7, 2022 Compounded Drugs Nationwide View Details →

PT-141 10mg/mL a) 1mL-vial, b) 2 mL-vial, Refrigerate, Tailor Made Compounding

TMC Acquisition LLC

Class I - Dangerous

Lack of Assurance of Sterility

Mar 7, 2022 Compounded Drugs Nationwide View Details →

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