Class II · Moderate risk Ongoing
Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia…
Reason Presence of foreign tablets/capsules.
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Class II · Moderate risk Ongoing
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd…
Reason Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of…
Class II · Moderate risk Ongoing
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd…
Reason Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of…
Class II · Moderate risk Ongoing
Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc…
Reason Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol
Class II · Moderate risk Ongoing
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA…
Reason cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Class I · High risk Completed
UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC…
Reason Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Class I · High risk Completed
UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: EREN NATURAL S.A. DE C.V, Zappan, Jal. C.P, UPC 7…
Reason Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and…
Class II · Moderate risk Ongoing
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO…
Reason Lack of Assurance of Sterility
Class III · Low risk Ongoing
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No…
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time…
Class II · Moderate risk Ongoing
Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by…
Reason cGMP deviations
Class II · Moderate risk Ongoing
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark…
Reason OOS results reported for the Dissolution (by UV) test.
Class II · Moderate risk Ongoing
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin…
Reason Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.