Class III · Low risk
Loperamide HCL Tablets USP
Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
FDA Drug Recalls
145 recalls · Class III, newest first
Class III · Low risk
COSOPT Ophthalmic Solution
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Class III · Low risk
Temozolomide Capsules
Failed Dissolution Specifications
Class III · Low risk
Temozolomide Capsules
Failed Dissolution Specifications
Class III · Low risk
Options Rx Anti-Oxidant Oil-Free Sunscreeen
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Class III · Low risk
Advanced Protection Sunscreen spf 30
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Class III · Low risk
Absorica (Isotretinoin)
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Class III · Low risk
NYSTATIN Oral Suspension
Failed Impurities/Degradation Specifications:Out of specification for impurities.
Class III · Low risk
Amlodipine and Olmesartan Medoxomil Tablets
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
Aprepitant Capsules
Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
Class III · Low risk
Norepinephrine 8 mg
Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Class III · Low risk
Nitrofurantoin Capsules USP
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
ERBITUX CETUXIMAB Injection
Labeling: Missing label; potential for missing primary container label on the vial.
Class III · Low risk
Nitrofurantoin Monohydrate/Macrocrystals capsules
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
AMITIZA (lubiprostone)
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
Class III · Low risk
Megestrol Acetate Oral Suspension
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Class III · Low risk
Nitrofurantoin Capsules
Cross Contamination with Other Products
Class III · Low risk
Nitrofurantoin Capsules
Cross Contamination with Other Products
Class III · Low risk
Curaplex Epi Safe Kit
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
Clindamycin Phosphate Topical Solution USP
Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
Class III · Low risk
Metoprolol Tartrate Injection
Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
Class III · Low risk
Prednisolone and Gatifloxacin Ophthalmic Solution
Presence of precipitate
Class III · Low risk
Metoprolol Tartrate Injection
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Class III · Low risk
Testosterone Topical Solution
Defective Container: Repetitive complaints received indicating pump not working.
Class III · Low risk
Temozolomide capsules
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.