Allegiant Health

Société pharmaceutique10 produits suivis

produits suivis

1 077 536

total des notifications

127

rappels enregistrés

58,2%

graves au total

Produits

affichage de 10 sur 10

Produit	Approuvé	Notifications ↓	Signal principal	Rappels
aspirin 325 mg —	—	500 597	Hémorragie GI	0
kit —	1974	360 069	—	100
ibuprofen 200mg —	—	195 216	Infection des voies respiratoires inférieures	1
esomeprazole magnesium capsule, delayed release —	—	14 106	Maladie rénale chronique	0
bismuth subsalicylate —	1996	5 686	Hypersécrétion acide de rebond	2
diphenhydramine hcl 25 mg —	—	728	Rhinorrhée	5
cetirizine hcl 10 mg —	—	412	Allergie saisonnière	1
mucus relief —	—	347	Récidive de la maladie	9
sleep aid —	—	301	Produit périmé administré	9
magnesium oxide 400mg —	—	74	Hospitalisation	0

Historique des rappels · 50 enregistrés

Date	Classe	Motif	Fabricant
17 mars 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 mars 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 mai 2024	III	Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.	Washington Homeopathic Products, Inc.
2 août 2023	II	CGMP Deviations	Parker Laboratories, Inc.
26 avr. 2023	II	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Akorn, Inc.
23 déc. 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 déc. 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 déc. 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 juin 2022	II	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.
23 juin 2022	II	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.
23 juin 2022	II	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.
16 juin 2022	II	Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.	Jubilant Draximage Inc
13 avr. 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
18 mars 2022	III	Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.	Advanced Accelerator Applications USA, Inc.
3 déc. 2021	III	Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.	Dental Alliance Holdings LLC
3 déc. 2021	III	Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.	Dental Alliance Holdings LLC
3 déc. 2021	III	Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.	Dental Alliance Holdings LLC
3 déc. 2021	III	Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.	Dental Alliance Holdings LLC
24 août 2021	I	Product Mix-up: Incorrect diluent component included in the kit.	Azurity Pharmaceuticals, Inc.
22 mars 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 mars 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 mars 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 avr. 2020	II	Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins	Sandoz, Inc
19 mars 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 mai 2019	II	Lack of Processing Controls.	Synthetopes Inc
28 mai 2019	II	Lack of Processing Controls.	Synthetopes Inc
25 mars 2019	II	Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.	Lohxa LLC
11 déc. 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 juil. 2018	I	Microbial contamination	King Bio Inc.
20 juil. 2018	I	Microbial contamination	King Bio Inc.
20 juil. 2018	I	Microbial contamination	King Bio Inc.
6 juin 2018	II	Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.	Pharmalucence, Inc.
26 avr. 2018	II	Lack of Assurance of Sterility	Coast Quality Pharmacy LLC
10 avr. 2018	II	Failed Stability Specifications	Pharmalucence, Inc.
3 avr. 2018	II	Lack of Processing Controls.	Kroger Specialty Pharmacy, Inc.
3 avr. 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

Classe I = probabilité raisonnable de préjudice grave · Classe II = temporaire ou réversible · Classe III = peu susceptible de causer un préjudice.

Statut d'enregistrement

Certains produits de Allegiant Health ne sont pas enregistrés auprès de la FDA pour un usage humain. Pour les substances non enregistrées (peptides, SARMs sans enregistrement humain), aucun fournisseur légitime à usage humain n'existe. L'absence de filière d'approvisionnement est l'information de sécurité.