Class II · Moderate risk
PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick
SubPotent: Out of Specification
FDA Drug Recalls
11,818 recalls · Class II, newest first
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 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.
Class II · Moderate risk
Xylocaine-MPF with Epinephrine 1:200
Low out of specification results for epinephrine assay.
Class II · Moderate risk
Acetaminophen 325 mg tablets
cGMP deviations: Discolored acetaminophen
Class II · Moderate risk
Solifenacin Succinate Tablets
CGMP Deviations
Class II · Moderate risk
Xolair (omalizumab)
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Class II · Moderate risk
QiYu Hand Sanitizer Gel
Subpotent
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.