Class II · Moderate risk Terminated
L-Cysteine Hydrochloride Injection
Reason Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation
Reason Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps.
Class II · Moderate risk Terminated
Levoxyl
Reason Superpotent
Class III · Low risk Terminated
Amoxicillin for Oral suspension
Reason Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Class III · Low risk Terminated
Diltiazem HCl Extended-release Capsules
Reason Failed Impurities/Degradation Specifications: OOS results for known compound.
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications; 6 month time point
Class II · Moderate risk Terminated
Papa/Phen/Prost
Reason Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Class II · Moderate risk Terminated
Papa/Phen/Prost
Reason Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Class II · Moderate risk Terminated
Metformin Hydrochloride Tablets
Reason Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Class III · Low risk Terminated
Qnasl
Reason Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Class III · Low risk Terminated
Qnasl
Reason Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Class II · Moderate risk Terminated
Fentanyl Citrate Injection
Reason Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Class I · High risk Terminated
Skinny Bee Diet capsules
Reason Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.
Class II · Moderate risk Terminated
Phenazopyridine Hydrochloride Tablets
Reason CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class II · Moderate risk Terminated
Phenazopyridine Hydrochloride Tablets
Reason CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class II · Moderate risk Terminated
Salsalate Tablets
Reason CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class II · Moderate risk Terminated
Salsalate Tablets
Reason CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Class III · Low risk Terminated
Kenalog
Reason Failed Stability Specifications: Low Out of Specification results for alcohol content.
Class III · Low risk Terminated
Bupropion Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Class II · Moderate risk Terminated
Phenazopyridine Hydrochloride Tablets
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk Terminated
Phenazopyridine Hydrochloride Tablets
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk Terminated
Indiomin MB URINARY ANTISEPTIC
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk Terminated
AZUPHEN MB URINARY ANTISEPTIC Capsules
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk Terminated
UROPHEN MB URINARY ANTISEPTIC Tablets
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Class II · Moderate risk Terminated
URAMIT MB URINARY ANTISEPTIC Capsules
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures