Class II · Moderate risk
amazon
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
FDA Drug Recalls
1,058 recalls, newest first
Class II · Moderate risk
GoodSense Aller.Ease
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
EQUALINE aller-ease fexofenadine hydrochloride tablets
Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing.
Class II · Moderate risk
Cholestene capsules
Marketed Without an Approved NDA/ANDA
Class II · Moderate risk
PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodide Cleansing Scrub Swabstick
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodine Cleansing Scrub Swabstick
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodine Swabstick
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidine Iodine Swabstick
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodine Prep Pad Large
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodine Prep Pad MEDIUM
SubPotent: Out of Specification
Class II · Moderate risk
Triamcinolone Acetonide Ointment USP
Correct Labeled Product Mispack
Class II · Moderate risk
Econazole Nitrate Cream 1%
Correct Labeled Product Mispack
Class II · Moderate risk
Tizanidine HCl Tablets
Failed Tablet/Capsule Specification: Some tablets are shaved
Class II · Moderate risk
Azelaic Acid 99.0+% Micro 500 Grams
cGMP Deviations
Class II · Moderate risk
Estriol USP41 Micro 25 Grams
cGMP Deviations
Class II · Moderate risk
QiYu Hand Sanitizer
Subpotent
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of Foreign Substance- Potential of metal contamination.
Class III · Low risk
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer
Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
Class I · High risk
Atovaquone Oral Suspension
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class II · Moderate risk
NIFEdipine EXTENDED-RELEASE TABLETS
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Class II · Moderate risk
MIC+Methyl B12 injection Methionine Inositol…
Lack of processing controls
Class II · Moderate risk
Global Hand Sanitizer with moisturizer
CGMP Deviations: Does not meet monograph for denaturant.
Class II · Moderate risk
Global Hand Sanitizer with moisturizer
CGMP Deviations: Does not meet monograph for denaturant.
Class II · Moderate risk
Zyprexa Intramuscular
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.