Class III · Low risk
DermOtic Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
FDA drug recalls in 2014
Every FDA drug recall initiated in 2014, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,309 recalls, newest first.
Class II · Moderate risk
GREENSTONE BRAND fluconazole for Oral Suspension
Defective Container: Tamper evident ring failures discovered on some bottles.
Class III · Low risk
Triamcinolone Acetonide Cream USP
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Class II · Moderate risk
Oxcarbazepine Tablets
Failed Tablet Specifications: Broken Tablets Present.
Class II · Moderate risk
Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil
Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
Class III · Low risk
Carisoprodol Tablets
Failed Impurity/degradation Specification
Class II · Moderate risk
Metformin HCl Extended-Release Tablets
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Class III · Low risk
Suprax
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Class III · Low risk
Suprax
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Class I · High risk
Meizitang Strong Version Botanical Slimming
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Class I · High risk
Magic Slim capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Class I · High risk
Slim Xtreme Weight loss capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Class I · High risk
Meizi Evolution Soft Gel Capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Class I · High risk
SlimEasy Herbs Capsule
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: sibutramine and N-desmethylsibutramine
Class I · High risk
Pill for weight reduction
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein
Class I · High risk
Super Fat Burning Bomb Capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine
Class I · High risk
Fruta BIO 400 mg capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein .
Class I · High risk
JIANFEIJINDAN Activity Girl Capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine, an analog of sibutramine
Class I · High risk
REDUCE WEIGHT FRUTA PLANTA Capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein.
Class II · Moderate risk
Teva Hydroxyzine Pamoate Capsules
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Class II · Moderate risk
Teva Dextroamphetamine Saccharate
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.
Class II · Moderate risk
Teva Hydroxyzine Pamoate Capsules
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Class II · Moderate risk
Teva Ethambutol Hydrochloride Tablets
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
Class II · Moderate risk
Heparin Sodium Injection
Subpotent; 18 month time point
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg.