Class II · Moderate risk Terminated
Cholestene capsules
Reason Marketed Without an Approved NDA/ANDA
FDA Drug Recalls
14,801 recalls, newest first
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 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 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 Terminated
QiYu Hand Sanitizer
Reason Subpotent
Class II · Moderate risk Terminated
Sulfamethoxazole and Trimethoprim Tablets
Reason Presence of Foreign Substance- Potential of metal contamination.
Class III · Low risk Terminated
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer
Reason 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 Terminated
Atovaquone Oral Suspension
Reason Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class II · Moderate risk Terminated
NIFEdipine EXTENDED-RELEASE TABLETS
Reason Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Class II · Moderate risk Terminated
MIC+Methyl B12 injection Methionine Inositol…
Reason Lack of processing controls
Class II · Moderate risk Terminated
Global Hand Sanitizer with moisturizer
Reason CGMP Deviations: Does not meet monograph for denaturant.
Class II · Moderate risk Terminated
Global Hand Sanitizer with moisturizer
Reason CGMP Deviations: Does not meet monograph for denaturant.
Class II · Moderate risk Terminated
Zyprexa Intramuscular
Reason cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Class II · Moderate risk Terminated
Xylocaine-MPF with Epinephrine 1:200
Reason Low out of specification results for epinephrine assay.
Class III · Low risk Terminated
Leukine
Reason FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
Class III · Low risk Terminated
Erythromycin Topical Gel
Reason Failed Impurities/Degradation Specifications