Class III · Low risk
Cetirizine HCl Chewable Tablet
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Class III drug recalls - low risk
Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.
1,716 recalls, newest first.
Class III · Low risk
Flurandrenolide Tape
Subpotent Drug: Flurandrenolide is subpotent.
Class III · Low risk
ImproVue Ophthalmic Lubricant Drops
Failed pH specification
Class III · Low risk
Monistat 1 Simple Cure
Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA requires both a 1200 mg vaginal suppository and the 2% topical cream.
Class III · Low risk
Olanzapine
Subpotent drug
Class III · Low risk
Olanzapine
Subpotent drug
Class III · Low risk
Olanzapine
Subpotent drug
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing
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
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