Class II · Moderate risk Terminated
CAREONE Allergy Relief
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
berkley jensen
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk Terminated
basic+care
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk Terminated
basic+care
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk Terminated
amazon
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk Terminated
GoodSense Aller.Ease
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk Terminated
EQUALINE aller-ease fexofenadine hydrochloride tablets
Reason Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk Terminated
Cholestene capsules
Reason Marketed Without an Approved NDA/ANDA
Class II · Moderate risk Terminated
PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick
Reason SubPotent: Out of Specification
Class II · Moderate risk Terminated
PDI Povidone-Iodide Cleansing Scrub Swabstick
Reason SubPotent: Out of Specification
Class II · Moderate risk Terminated
PDI Povidone-Iodine Cleansing Scrub Swabstick
Reason SubPotent: Out of Specification
Class II · Moderate risk Terminated
PDI Povidone-Iodine Swabstick
Reason SubPotent: Out of Specification
Class II · Moderate risk Terminated
PDI Povidine Iodine Swabstick
Reason SubPotent: Out of Specification
Class II · Moderate risk Terminated
PDI Povidone-Iodine Prep Pad Large
Reason SubPotent: Out of Specification
Class II · Moderate risk Terminated
PDI Povidone-Iodine Prep Pad MEDIUM
Reason SubPotent: Out of Specification
Class II · Moderate risk Ongoing
Miss Slim
Reason Marketed without ANDA/NDA approval
Class II · Moderate risk Terminated
Triamcinolone Acetonide Ointment USP
Reason Correct Labeled Product Mispack
Class II · Moderate risk Terminated
Econazole Nitrate Cream 1%
Reason Correct Labeled Product Mispack
Class II · Moderate risk Terminated
Tizanidine HCl Tablets
Reason Failed Tablet/Capsule Specification: Some tablets are shaved
Class I · High risk Ongoing
ALPHA MALE+ Male Enhancer
Reason Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Class II · Moderate risk Terminated
Azelaic Acid 99.0+% Micro 500 Grams
Reason cGMP Deviations
Class II · Moderate risk Terminated
Estriol USP41 Micro 25 Grams
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Neutrogena Beach Defense water+sun protection sunscreen spray…
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Neutrogena Beach Defense water+sun protection sunscreen spray…
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Neutrogena Beach Defense water+sun protection sunscreen spray…
Reason cGMP Deviations