Drug and pharmaceutical recalls
17732 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-07-13FDA-DrugVital Care Compounder, LLCClass IITESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial on all containers.
- 2016-07-13FDA-DrugXTREME Z DISTRIBUTORS INCClass IZero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180
Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.
- 2016-07-13FDA-DrugCantrell Drug CompanyClass IIMIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-001-16 UPC: 0100352533001161
Subpotent Drug
- 2016-07-13FDA-DrugCantrell Drug CompanyClass IIMIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993721
Subpotent Drug
- 2016-07-13FDA-DrugCantrell Drug CompanyClass IIMidazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL syringes, Rx Only, Cantrell Drug Co., Little Rock AR --- NDC 52533-157-45, UPC: 0100352533157455
Subpotent Drug
- 2016-07-13FDA-DrugCantrell Drug CompanyClass IILIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection, packaged in 3 mL Syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992033
Subpotent Drug
- 2016-07-13FDA-DrugCantrell Drug CompanyClass IIHEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-148-16, UPC: 0100352533148163
Stability Data Does Not Support Expiry
- 2016-07-13FDA-DrugCantrell Drug CompanyClass IIHEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992212
Stability Data Does Not Support Expiry
- 2016-07-13FDA-DrugCantrell Drug CompanyClass IfentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-074-16, UPC: 0100352533074165
Subpotent Drug
- 2016-07-13FDA-DrugCantrell Drug CompanyClass IfentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection, in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993491
Subpotent Drug
- 2016-07-13FDA-DrugCantrell Drug CompanyClass IfentaNYL citrate in 0.9% Sodium Chloride Injection, 5 mcg/1 mL (5 mcg/mL), in a) 1 mL syringe (NDC 52533-214-45, UPC: 0100352533214455) and b) 3 mL syringe (NDC 52533-214-60, UPC: 0100352533214608), Rx Only, Cantrell Drug Co., Little Rock, AR
Subpotent Drug
- 2016-07-13FDA-DrugCantrell Drug CompanyClass IfentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection, in 2 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock AR --- UPC: 9999993301
Subpotent Drug
- 2016-07-13FDA-DrugCantrell Drug CompanyClass IfentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992131
Subpotent Drug
- 2016-07-13FDA-DrugCantrell Drug CompanyClass IAtropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL), in a) 1 mL syringes and b) 2 mL syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-010-45, UPC: 0100352533010453
Subpotent Drug
- 2016-07-13FDA-DrugCantrell Drug CompanyClass IfentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-024-45, UPC: 0100352533024450
Subpotent Drug
- 2016-07-13FDA-DrugBee Extremely Amazed LLCClass IZI XIU TANG BEAUTY FACE & FIGURE Capsules, 250 mg, 60-count bottles
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.
- 2016-07-13FDA-DrugBee Extremely Amazed LLCClass IXCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
- 2016-07-13FDA-DrugBee Extremely Amazed LLCClass IXCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared fluoxetine, an FDA approved drug used to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
- 2016-07-13FDA-DrugBee Extremely Amazed LLCClass IUltimate Formula Capsules, 250mg, 48-count bottles, Manufactured for: Zi Xiu Tang Success, LLC Trexlertown, PA 18087, USA www.zixiutangsuccess.com
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.
- 2016-07-13FDA-DrugBee Extremely Amazed LLCClass ISLIM TRIM U Capsules, 250mg, 60-count bottles, Manufactured for Floyd Nutrition
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.
- 2016-07-13FDA-DrugBee Extremely Amazed LLCClass ISlimeX-15 Capsules, 15 mg, 30-count bottles, Marketed by: Signature Pharmaceuticals Ltd. MUMBAI-400-030 Manufactured in India by: HAB Pharmaceuticals & Research Limited 10-Pharma City, SIDCUL, Selaqui, Dehradun, 248 197
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.
- 2016-07-13FDA-DrugBee Extremely Amazed LLCClass IPrime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St. #392 Columbus, IN 47203
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
- 2016-07-13FDA-DrugBee Extremely Amazed LLCClass IOasis Capsules, 500mg, 45-count bottles, Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando FL 32801 (407)930-4043
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
- 2016-07-13FDA-DrugBee Extremely Amazed LLCClass ILa' Trim Plus Capsules, 350 mg, 60-count bottles, Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando, FL 32801 (407) 930-4043
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
- 2016-07-13FDA-DrugBee Extremely Amazed LLCClass IJenesis Capsules, 350 mg, 60-count bottles, Manufactured for Timeless Solutions 1810 E. Sahara Ave #100 Las Vegas, Nevada 89104
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
- 2016-07-13FDA-DrugBee Extremely Amazed LLCClass IInfinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.
- 2016-07-13FDA-DrugBee Extremely Amazed LLCClass IEVOLVE BEE POLLEN Capsules, 250mg, 60-count bottles, Manufactured for 2637 E. Atlantic Blvd, Pompano Beach, Florida, 33062 WWW.BEEEXTREMELYAMAZED.COM
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
- 2016-07-13FDA-DrugBee Extremely Amazed LLCClass IAsset extreme+PLUS Capsules, 500 mg, 30-count bottles, Distributed by Descor, LLC www.assetcapsules4u.com www.allnaturalbeelievers.com
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.
- 2016-07-13FDA-DrugBee Extremely Amazed LLCClass IAsset BOLD Capsules, 500 mg, 60-count bottles, Distributed by Descor, LLC www.assetcapsules4u.com
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
- 2016-07-13FDA-DrugHospira Inc.Class IMagnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
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