Class II · Moderate risk Terminated
PDI Povidone-Iodine Swabstick
Reason SubPotent: Out of Specification
FDA Drug Recalls
11,815 recalls · Class II, newest first
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 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 II · Moderate risk Terminated
Acetaminophen 325 mg tablets
Reason cGMP deviations: Discolored acetaminophen
Class II · Moderate risk Terminated
Solifenacin Succinate Tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
Xolair
Reason 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 Terminated
QiYu Hand Sanitizer Gel
Reason Subpotent
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk Terminated
DermOtic Oil
Reason Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Class II · Moderate risk Terminated
Diflorasone Diacetate Ointment USP
Reason Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Class II · Moderate risk Terminated
Native Fluoride Toothpaste for Sensitive Teeth
Reason Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride