| Aug 6, 2025 |
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured... |
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above... |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Aug 6, 2025 |
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactur... |
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above... |
Class II |
Glenmark Pharmaceuticals Inc., USA |
| Aug 5, 2025 |
Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Front... |
Presence of foreign substance: identified as aluminum. |
Class II |
SUN PHARMACEUTICAL INDUSTRIES INC |
| Aug 5, 2025 |
Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled ... |
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, cont... |
Class II |
Cardinal Health Inc. |
| Aug 4, 2025 |
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), R... |
Lack of Assurance of Sterility. |
Class II |
PFIZER INC |
| Aug 4, 2025 |
Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distri... |
Lack of Assurance of Sterility. |
Class II |
PFIZER INC |
| Aug 4, 2025 |
Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Ste... |
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. |
Class II |
B BRAUN MEDICAL INC |
| Aug 4, 2025 |
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, ... |
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. |
Class II |
B BRAUN MEDICAL INC |
| Jul 30, 2025 |
Bacteriostatic Water for Injection, all strengths and presentations, GenoGeni... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Magnesium Chloride 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 |
L-Arginine for Injection, all strengths and presentations, GenoGenix, LLC, 28... |
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 Hydroxocobalamin for Injection, all strengths and presentations, GenoGeni... |
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 |
Biotin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 N... |
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 |
Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, ... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Calcium Chloride for Injection, all strengths and presentations, GenoGenix, L... |
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 |
B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Reconstitution XO Solution for Injection, all strengths and presentations, Ge... |
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 |
BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 284... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL mu... |
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 |
Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 ... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
L-Carnitine for Injection, all strengths and presentations, GenoGenix, LLC, 2... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Methylene Blue for Injection, all strengths and presentations, GenoGenix, LLC... |
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 |
Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentatio... |
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 |
EDTA for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW ... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2... |
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 |
pH Buffered Reconstitution Solution for Injection, all strengths and presenta... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Take... |
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... |
Class II |
Cardinal Health Inc. |
| Jul 30, 2025 |
Cerebrolysin for Injection, all strengths and presentations, GenoGenix, LLC, ... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Lysine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 N... |
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 |
| 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 |
Retatrutide for Injection, 60mg / 10mL vial, all presentations, GenoGenix, LL... |
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 |
GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoG... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix... |
Lack of Assurance of Sterility |
Class II |
GenoGenix LLC |
| Jul 30, 2025 |
Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 N... |
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 |
Zinc Sulfate 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 |