Class III · Low risk Terminated
Options Rx Anti-Oxidant Oil-Free Sunscreeen
Reason Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Advanced Protection Sunscreen spf 30
Reason Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Class III · Low risk Terminated
Absorica
Reason Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Class III · Low risk Terminated
NYSTATIN Oral Suspension
Reason Failed Impurities/Degradation Specifications:Out of specification for impurities.
Class III · Low risk Terminated
Amlodipine and Olmesartan Medoxomil Tablets
Reason Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
Class III · Low risk Terminated
Aprepitant Capsules
Reason Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
Class III · Low risk Terminated
Norepinephrine 8 mg
Reason Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Class III · Low risk Terminated
Nitrofurantoin Capsules USP
Reason Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation."
Class III · Low risk Terminated
ERBITUX CETUXIMAB Injection
Reason Labeling: Missing label; potential for missing primary container label on the vial.
Class III · Low risk Terminated
Nitrofurantoin Monohydrate/Macrocrystals capsules
Reason Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).
Class III · Low risk Terminated
Amitiza
Reason Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Class III · Low risk Terminated
Megestrol Acetate Oral Suspension
Reason Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Class III · Low risk Terminated
Nitrofurantoin Capsules
Reason Cross Contamination with Other Products
Class III · Low risk Terminated
Nitrofurantoin Capsules
Reason Cross Contamination with Other Products
Class III · Low risk Terminated
Curaplex Epi Safe Kit
Reason Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May 2018 however the correct expiration date is May 2019. In addition, device component (syringe) lacks 510(k) clearance.
Class III · Low risk Terminated
Clindamycin Phosphate Topical Solution USP
Reason Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
Class III · Low risk Terminated
Metoprolol Tartrate Injection
Reason Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
Class III · Low risk Terminated
Prednisolone and Gatifloxacin Ophthalmic Solution
Reason Presence of precipitate
Class III · Low risk Terminated
Metoprolol Tartrate Injection
Reason Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Class III · Low risk Terminated
Testosterone Topical Solution
Reason Defective Container: Repetitive complaints received indicating pump not working.
Class III · Low risk Terminated
Temozolomide capsules
Reason Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Class III · Low risk Terminated
Contrave
Reason Container packaging defect.
Class III · Low risk Terminated
Amlodipine Besylate USP 10 mg Tablets
Reason Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
Class III · Low risk Terminated
Levofloxacin Injection in 5% Dextrose
Reason Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Class III · Low risk Terminated
Tadalafil SR 12 mg Capsules packed in 8
Reason Labeling Not Elsewhere Classified: Misbranding.