| Feb 2, 2026 |
Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4... |
cGMP deviations |
Class II |
Pro Numb Tattoo Numbing Spray LLC |
| Feb 2, 2026 |
Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL]... |
cGMP deviations |
Class II |
Pro Numb Tattoo Numbing Spray LLC |
| Nov 13, 2025 |
Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syr... |
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate ... |
Class II |
Lupin Pharmaceuticals Inc. |
| Nov 5, 2025 |
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Ma... |
Defective container - seal not adhering to bottles |
Class II |
Lupin Pharmaceuticals Inc. |
| Sep 5, 2025 |
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Man... |
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to po... |
Class II |
Apotex Corp. |
| Sep 5, 2025 |
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL ... |
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to po... |
Class II |
Apotex Corp. |
| Jul 30, 2025 |
Ultra Burn for Injection, all strengths and presentations, GenoGenix, LLC, 28... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Semaglutide with B12 for Injection, all strengths and presentations, GenoGeni... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Sterile Saline Reconstitution Solution for Injection, all strengths and prese... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGeni... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL M... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, ... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Low Solubility Peptide Reconstitution Solution for Injection, all strengths a... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
L-Arginine HCl for Injection, all strengths and presentations, GenoGenix, LLC... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Thymosin Beta-4 (TB4) for Injection, 15mg, all presentations, GenoGenix, LLC,... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and present... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Zinc Chloride for Injection, all strengths and presentations, GenoGenix, LLC,... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
L-Glutamine for Injection, all strengths and presentations, GenoGenix, LLC, 2... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations,... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
CoQ10 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 m... |
Microbial Contamination of Sterile Products: elevated endotoxin levels |
Class I |
GenoGenix LLC |
| Jul 30, 2025 |
Zinc Sulfate for Injection, all strengths and presentations, GenoGenix, LLC, ... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Pentosan for Injection, all strengths and presentations, GenoGenix, LLC, 2840... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 284... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
GAC for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Elite Stack Reconstitution Solution for Injection, all strengths and presenta... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths ... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
pH Buffered Reconstitution Solution for Injection, all strengths and presenta... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, Geno... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 ... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LL... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, ... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Lipo MIC + L-Carnitine for Injection, all strengths and presentations, GenoGe... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW ... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGeni... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Oxytocin for Injection, all strengths and presentations, GenoGenix, LLC, 2840... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Glutathione Preserved for Injection, all strengths and presentations, GenoGen... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Glutathione Magnesium for Injection, all strengths and presentations, GenoGen... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LL... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 284... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Vitamin D3 for Injection, all strengths and presentations, GenoGenix, LLC, 28... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Tri-Immune for Injection, all strengths and presentations, GenoGenix, LLC, 28... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 28... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 ... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Bacteriostatic Water for Injection, all strengths and presentations, GenoGeni... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentatio... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 ... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |