Allegiant Health

Compañía farmacéutica10 productos registrados

productos registrados

1.077.536

notificaciones totales

127

retiradas registradas

58,2%

graves en total

Productos

mostrando 10 de 10

Producto	Aprobado	Notificaciones ↓	Señal principal	Retiradas
aspirin 325 mg —	—	500.597	Hemorragia GI	0
kit —	1974	360.069	—	100
ibuprofen 200mg —	—	195.216	Infección de las vías respiratorias inferiores	1
esomeprazole magnesium capsule, delayed release —	—	14.106	Enfermedad renal crónica	0
bismuth subsalicylate —	1996	5686	Hipersecreción ácida de rebote	2
diphenhydramine hcl 25 mg —	—	728	Rinorrea	5
cetirizine hcl 10 mg —	—	412	Alergia estacional	1
mucus relief —	—	347	Recurrencia de la enfermedad	9
sleep aid —	—	301	Producto caducado administrado	9
magnesium oxide 400mg —	—	74	Hospitalización	0

Historial de retiradas · 50 registradas

Fecha	Clase	Motivo	Empresa
17 mar 2026	II	Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.	Teva Pharmaceuticals USA, Inc
17 mar 2026	II	Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.	Teva Pharmaceuticals USA, Inc
22 nov 2024	II	Failed Stability Specifications	Jubilant Draximage Inc., dba Jubilant Radiopharma
31 may 2024	III	Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.	Washington Homeopathic Products, Inc.
2 ago 2023	II	CGMP Deviations	Parker Laboratories, Inc.
26 abr 2023	II	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Akorn, Inc.
23 dic 2022	I	Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.	GFA Production Xiamen Co. Ltd.
23 dic 2022	I	Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.	GFA Production Xiamen Co. Ltd.
23 dic 2022	I	Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.	GFA Production Xiamen Co. Ltd.
23 jun 2022	II	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.
23 jun 2022	II	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.
23 jun 2022	II	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.
16 jun 2022	II	Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.	Jubilant Draximage Inc
13 abr 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
18 mar 2022	III	Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.	Advanced Accelerator Applications USA, Inc.
3 dic 2021	III	Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.	Dental Alliance Holdings LLC
3 dic 2021	III	Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.	Dental Alliance Holdings LLC
3 dic 2021	III	Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.	Dental Alliance Holdings LLC
3 dic 2021	III	Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.	Dental Alliance Holdings LLC
24 ago 2021	I	Product Mix-up: Incorrect diluent component included in the kit.	Azurity Pharmaceuticals, Inc.
22 mar 2021	II	Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.	Novo Nordisk Inc
22 mar 2021	II	Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.	Novo Nordisk Inc
22 mar 2021	II	Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.	Novo Nordisk Inc
21 abr 2020	II	Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins	Sandoz, Inc
19 mar 2020	II	Failed Stability Specifications	Jubilant Draximage Inc
31 oct 2019	II	Microbial contamination of non-sterile product.	Fagron, Inc
26 sept 2019	II	Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.	Alkermes, Inc.
28 may 2019	II	Lack of Processing Controls.	Synthetopes Inc
28 may 2019	II	Lack of Processing Controls.	Synthetopes Inc
25 mar 2019	II	Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.	Lohxa LLC
11 dic 2018	I	Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex	Asclemed USA Inc. dba Enovachem
16 nov 2018	II	cGMP violations noted during the firm's most recent inspection.	CAO Group, Inc.
2 nov 2018	II	Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.	Bound Tree Medical, LLC
2 nov 2018	II	Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.	Bound Tree Medical, LLC
1 nov 2018	II	Labeling: Incorrect or Missing Lot and/or Exp date: vials of epinephrine within kit 8600-01100 expired on December 2018, but the outer kit label has an expiration date of January 2020. In addition, device component (syringe) may lack 510(k) clearance.	Bound Tree Medical, LLC
10 sept 2018	II	Lack of Assurance of Sterility	Pharm D Solutions, LLC
20 jul 2018	I	Microbial contamination	King Bio Inc.
20 jul 2018	I	Microbial contamination	King Bio Inc.
20 jul 2018	I	Microbial contamination	King Bio Inc.
6 jun 2018	II	Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.	Pharmalucence, Inc.
26 abr 2018	II	Lack of Assurance of Sterility	Coast Quality Pharmacy LLC
10 abr 2018	II	Failed Stability Specifications	Pharmalucence, Inc.
3 abr 2018	II	Lack of Processing Controls.	Kroger Specialty Pharmacy, Inc.
3 abr 2018	II	Lack of Processing Controls.	Kroger Specialty Pharmacy, Inc.
21 sept 2017	II	Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.	Medline Industries Inc
21 sept 2017	II	Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.	Medline Industries Inc
21 sept 2017	II	Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.	Medline Industries Inc
21 sept 2017	II	Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.	Medline Industries Inc
21 sept 2017	II	Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.	Medline Industries Inc
21 sept 2017	II	Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.	Medline Industries Inc

Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.

Estado de registro

Algunos productos de Allegiant Health no están registrados por la FDA para uso humano. Para las sustancias no registradas (péptidos, SARM sin registro humano) no existe ningún proveedor legítimo para uso humano. La ausencia de una vía de aprovisionamiento es la información de seguridad.