Class II · Moderate risk Terminated
fentaNYL 200 mcg/100 mL
Reason Lack of Assurance of Sterility
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
fentaNYL 2
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 2
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
LET Gel
Reason Product Mix-up: Incorrect Product Formulation
Class II · Moderate risk Terminated
Oxygen
Reason cGMP Deviations
Class I · High risk Ongoing
Dr. Ergin's SugarMD
Reason MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide
Class II · Moderate risk Ongoing
Naproxen Tablets
Reason Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Class II · Moderate risk Ongoing
Indomethacin 25mg Capsules
Reason Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Class I · High risk Terminated
Vitrakvi
Reason Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
Class III · Low risk Terminated
Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP
Reason Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Class II · Moderate risk Ongoing
Trospium Chloride Extended-Release Capsules
Reason Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Class II · Moderate risk Ongoing
Paroxetine Hydrochloride Tablets USP
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk Ongoing
Paroxetine Hydrochloride Tablets USP
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk Ongoing
Paroxetine Hydrochloride Tablets USP
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk Ongoing
Paroxetine Hydrochloride Tablets USP
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class I · High risk Ongoing
LEADER brand Lubricant Eye Drops
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing
LEADER brand Dry Eye Relief
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing
LEADER brand Lubricant Eye Drops
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing
LEADER brand Lubricant Eye Drops
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing
LEADER brand Dry Eye Relief
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing
LEADER brand Eye Irritation Relief
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Terminated
Lubricating Tears Eye Drops
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Terminated
Polyvinyl Alcohol 1.4% Lubricating Eye Drops
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class III · Low risk Terminated
V-FORCE Homeopathic
Reason Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).