CGMP Deviations: recalling drug products following an FDA inspection.
Prescription Drugs
💊 Drugs • 11,927 recalls
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.
PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1.
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.
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-315-25.
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.
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-302-10.
Nephron Sterile Compounding Center
Lack of Assurance of Sterility
CGMP Deviations: recalling drug products following an FDA inspection.