Class II · Moderate risk Ongoing
Glycopyrrolate Tablets
Reason Failed Impurities/Degradation Specifications
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Global Care 70% Alcohol Ethyl Rubbing Alcohol
Reason cGMP Deviations
Class II · Moderate risk Terminated
Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original
Reason cGMP Deviations
Class II · Moderate risk Terminated
Easy Clean 75% Ethyl Alcohol
Reason cGMP Deviations
Class II · Moderate risk Terminated
Easy Clean 70% Isopropyl Alcohol
Reason cGMP Deviations
Class II · Moderate risk Terminated
Easy Clean Isopropyl Alcohol 99%
Reason cGMP Deviations
Class II · Moderate risk Terminated
Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol
Reason cGMP Deviations
Class II · Moderate risk Terminated
Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine
Reason cGMP Deviations
Class II · Moderate risk Terminated
Rifampin Capsules USP
Reason Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Class II · Moderate risk Terminated
Menastil
Reason cGMP Deviations
Class II · Moderate risk Terminated
ProSirona
Reason cGMP Deviations
Class II · Moderate risk Terminated
Neuroquell
Reason cGMP Deviations
Class II · Moderate risk Terminated
Neuroquell Plus
Reason cGMP Deviations
Class II · Moderate risk Completed
Alcohol Antiseptic 80% Topical Solution Hand Sanitizer
Reason CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
Class II · Moderate risk Terminated
Thiamine Hydrochloride 3000 mg/30 mL
Reason Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Class II · Moderate risk Terminated
Thiamine Hydrochloride 200 mg/2mL
Reason Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Class II · Moderate risk Terminated
Quinapril Tablets USP
Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class II · Moderate risk Terminated
Quinapril Tablets USP
Reason CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Class I · High risk Terminated
Advil Liqui Gels
Reason Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I · High risk Terminated
Advil Liqui Gels
Reason Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I · High risk Terminated
Advil
Reason Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class III · Low risk Terminated
Lacosamide Oral Solution
Reason Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Class II · Moderate risk Terminated
Desmopressin Acetate Tablet
Reason Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Class II · Moderate risk Completed
TUMS Antacid
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Class II · Moderate risk Completed
TUMS Antacid
Reason Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.