Class II · Moderate risk
Good Neighbor Pharmacy
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Desloratadine Tablets USP 5mg a) 100 count
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Class II · Moderate risk
Tacrolimus Capsules
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Class II · Moderate risk
Selenium Sulfide 2.25% Shampoo
CGMP Deviations: Stability data does not support expiry date.
Class III · Low risk
Anoro Ellipta
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Class II · Moderate risk
Sertraline Tablets
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Class II · Moderate risk
Nystatin 150 Mu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 2 Bu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 500 Mu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class II · Moderate risk
Nystatin 5bu
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Class III · Low risk
Eprontia (topiramate)
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Class II · Moderate risk
Liothyronine Sodium Tablets
Failed Impurities/Degradation Specifications
Class I · High risk
Magnum XXL 9800
Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.
Class II · Moderate risk
ROPivacaine HCl 0.2% PF in Sodium Chloride 1
STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.
Class II · Moderate risk
Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution
Presence of Particulate Matter.
Class II · Moderate risk
B-Complex
Presence of Particulate Matter.
Class I · High risk
TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder
Chemical Contamination; presence of benzene.
Class II · Moderate risk
Penicillamine Tablets USP 250 mg
Failed Dissolution Specifications
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Class II · Moderate risk
ceFAZolin sodium in Sterile Water for injection
Lack of assurance of sterility.
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications
Class III · Low risk
Votrient (pazopanib)
Failed Dissolution Specifications
Class I · High risk
Vigabatrin for Oral Solution
Defective Container: powder may leak out of the pouch
Class II · Moderate risk
Ondansetron Injection
Failed pH Specifications
Class I · High risk
Up&Up brand dry eye relief
Non-Sterility