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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.243% sodium fluoride, Net Wt. 5.6 oz (158 g) a) Individual carton, UPC 0 37000 598534; b) 5-count Bundle, UPC 037000171867, Distributed. By Procter & Gamble, Cincinnati, OH 45202.

The Procter & Gamble Company

Class I - Dangerous

Labeling: Missing label: the product tube was missing a label and contained a different formulation.

Jul 8, 2022 Other Drugs View Details →

Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30

Teva Pharmaceuticals USA

Class I - Dangerous

Superpotent Drug: Out of specification assay result was obtained during stability testing.

Jun 29, 2022 Prescription Drugs Nationwide View Details →

Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specialty L.P., Morgantown, WV

Mylan Pharmaceuticals

Class I - Dangerous

Labeling: Missing label: Label missing from some prefilled pens.

Jul 5, 2022 Prescription Drugs Nationwide View Details →

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856179, NDC 43598-561-78

Dr. Reddy's Laboratories

Class I - Dangerous

FAILED DISSOLUTION SPECIFICATIONS

Jul 13, 2022 Prescription Drugs Nationwide View Details →

Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Pfizer

Class I - Dangerous

Presence of particulate matter: particulate identified as a beetle.

Jul 13, 2022 Prescription Drugs Nationwide View Details →

Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88.

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.

Jun 27, 2022 Prescription Drugs Nationwide View Details →

Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704

Valor Compounding Pharmacy, Inc

Class I - Dangerous

Subpotent and Superpotent Drug

Jun 27, 2022 Prescription Drugs View Details →

Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566

Eco Lips

Class I - Dangerous

Failed Dissolution Specifications

Jun 29, 2022 Other Drugs View Details →

Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-447-90

Jubilant Cadista Pharmaceuticals

Class I - Dangerous

Failed Dissolution Specifications

Jul 18, 2022 Prescription Drugs Nationwide View Details →

Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant pour les Levres, NET WT 0.15 oz (4.25 g) per tube, Active Ingredient: Zinc oxide 4%, Manufactured for Juice Beauty, Inc., 709 Fifth Ave., San Rafael, California 94901-3566

Eco Lips

Class I - Dangerous

Failed Dissolution Specifications

Jun 29, 2022 Other Drugs View Details →

Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd. Roorkee- 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-448-90

Jubilant Cadista Pharmaceuticals

Class I - Dangerous

Failed dissolution specifications.

Jul 18, 2022 Prescription Drugs Nationwide View Details →

Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-919-10

Nephron Sterile Compounding Center

Class I - Dangerous

Lack of Assurance of Sterility

Jun 30, 2022 Prescription Drugs Nationwide View Details →

Artri Ajo King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINALES DE MEXICO , Melchor Ocampo No. 55 Local D, Delegacion Xochimilco. C.P. 16800, Mexico, D.F., ASIN B092P4615M, UPC 7 501031 111190

Amazon.com

Class I - Dangerous

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.

May 26, 2022 Prescription 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 →

Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton containing 30 tablets (500 mg c/u) in a bottle and 60 capsules (400 mg c/u) in a bottle, Hecho en Mexico por: Omega Nutrition , Jorge Washington No. 108 Col. Las Americas, Hidalgo del Parral, Chihuahua. C.P. 33880, ASIN B084L2XM3Z, UPC 3166557819586

Amazon.com

Class I - Dangerous

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.

May 26, 2022 Prescription Drugs Nationwide View Details →

Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ketorolac Tromethamine 15 mg (0.3 mg/mL) Injection, 50 mL syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-515-50

Nephron Sterile Compounding Center

Class I - Dangerous

Lack of Assurance of Sterility

Jun 30, 2022 Prescription Drugs Nationwide View Details →

Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine HCl 60 mg (1.2 mg/mL) Injection, 50 mL syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-514-50

Nephron Sterile Compounding Center

Class I - Dangerous

Lack of Assurance of Sterility

Jun 30, 2022 Prescription Drugs Nationwide View Details →

8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syringe, packaged in 1 x 50 mL Pre-Filled Syringe per carton, 30 x 1 syringe carton per case, Rx Only Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-214-50

Nephron Sterile Compounding Center

Class I - Dangerous

Lack of Assurance of Sterility

Jun 30, 2022 Prescription Drugs Nationwide View Details →

Morphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-30

Nephron Sterile Compounding Center

Class I - Dangerous

Lack of Assurance of Sterility

Jun 30, 2022 Prescription Drugs Nationwide View Details →

Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55

Nephron Sterile Compounding Center

Class I - Dangerous

Lack of Assurance of Sterility

Jun 30, 2022 Prescription Drugs Nationwide View Details →