Class III · Low risk
Cartia XT (diltiazem HCl extended-release capsules, USP)
Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
FDA Drug Recalls
142 recalls · Class III, newest first
Class III · Low risk
Promethazine Vc With Codeine Syrup
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
Class III · Low risk
Fluorescein Sodium Ophthalmic Strips USP
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.
Class III · Low risk
Rose Bengal GloStrips
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of rose bengal present in the strips.
Class III · Low risk
Fluorescein Sodium Ophthalmic Strips USP
Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.
Class III · Low risk
Fexofenadine HCl Tablets
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Class III · Low risk
Air Compressed
Failed Impurities/Degradation Specification; out of specification results for carbon dioxide
Class III · Low risk
Quinapril Tablets USP
Subpotent Drug
Class III · Low risk
Quinapril Tablets USP
Subpotent Drug
Class III · Low risk
Oxecta (oxycodone HCl)
Failed Impurities/Degradation Specifications
Class III · Low risk
Oxecta (oxycodone HCl)
Failed Impurities/Degradation Specifications
Class III · Low risk
Fentanyl Citrate Inj.
Failed Impurities/Degradation Specifications; 12 month stability testing.
Class III · Low risk
Bromfenac Ophthalmic Solution 0.09%
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
Class III · Low risk
Z-Cote Hp 1 Transparent Zinc Oxide
Labeling: Illegible label. Writing is rubbing off of labels.
Class III · Low risk
DOXOrubicin Hydrochloride Injection
Correct Labeled Product Mispack: Ifosfamide Injection 50 mg/mL, 60 mL, correctly labeled vial may have been mis-packaged in a carton labeled Doxorubicin Hydrochloride Injection 2 mg/mL, 100 mL
Class III · Low risk
Nicardipine Hydrochloride Injection
Subpotent Drug and Failed Impurities/Degradation Specifications
Class III · Low risk
5-methyltetrahydrofolate Calcium
Subpotent Drug