Prescription and over-the-counter medications
Sciegen Pharmaceuticals
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
CGMP Deviations: recalling drug products following an FDA inspection.
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Volt Candy Wholesale Club
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: Potential product carryover.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
Nephron Sterile Compounding Center
Lack of Assurance of Sterility
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.