Allegiant Health

Pharmaunternehmen10 erfasste Produkte

erfasste Produkte

1.077.536

Meldungen insgesamt

127

dokumentierte Rückrufe

58,2%

schwerwiegend insgesamt

Produkte

10 von 10 angezeigt

Produkt	Zugelassen	Meldungen ↓	Top-Signal	Rückrufe
aspirin 325 mg —	—	500.597	GI-Blutung	0
kit —	1974	360.069	—	100
ibuprofen 200mg —	—	195.216	Infektion der unteren Atemwege	1
esomeprazole magnesium capsule, delayed release —	—	14.106	Chronische Nierenerkrankung	0
bismuth subsalicylate —	1996	5.686	Rebound-Säurehypersekretion	2
diphenhydramine hcl 25 mg —	—	728	Nasenlaufen	5
cetirizine hcl 10 mg —	—	412	Saisonale Allergie	1
mucus relief —	—	347	Wiederauftreten der Krankheit	9
sleep aid —	—	301	Verabreichtes abgelaufenes Produkt	9
magnesium oxide 400mg —	—	74	Krankenhausaufenthalt	0

Rückrufhistorie · 50 dokumentiert

Datum	Klasse	Grund	Firma
17. März 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. März 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. Aug. 2023	II	CGMP Deviations	Parker Laboratories, Inc.
26. Apr. 2023	II	CGMP Deviations: Firm went out of business and could no longer continue stability studies.	Akorn, Inc.
23. Dez. 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. Dez. 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. Dez. 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. Juni 2022	II	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.
23. Juni 2022	II	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.
23. Juni 2022	II	CGMP Deviations: product held outside appropriate storage temperature conditions.	Family Dollar Stores, Llc.
16. Juni 2022	II	Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.	Jubilant Draximage Inc
13. Apr. 2022	II	cGMP deviations: Temperature abuse	Mckesson Medical-Surgical Inc. Corporate Office
18. März 2022	III	Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.	Advanced Accelerator Applications USA, Inc.
3. Dez. 2021	III	Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.	Dental Alliance Holdings LLC
3. Dez. 2021	III	Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.	Dental Alliance Holdings LLC
3. Dez. 2021	III	Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.	Dental Alliance Holdings LLC
3. Dez. 2021	III	Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.	Dental Alliance Holdings LLC
24. Aug. 2021	I	Product Mix-up: Incorrect diluent component included in the kit.	Azurity Pharmaceuticals, Inc.
22. März 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. März 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. März 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. Apr. 2020	II	Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins	Sandoz, Inc
19. März 2020	II	Failed Stability Specifications	Jubilant Draximage Inc
31. Okt. 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. März 2019	II	Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.	Lohxa LLC
11. Dez. 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. Juli 2018	I	Microbial contamination	King Bio Inc.
20. Juli 2018	I	Microbial contamination	King Bio Inc.
20. Juli 2018	I	Microbial contamination	King Bio Inc.
6. Juni 2018	II	Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.	Pharmalucence, Inc.
26. Apr. 2018	II	Lack of Assurance of Sterility	Coast Quality Pharmacy LLC
10. Apr. 2018	II	Failed Stability Specifications	Pharmalucence, Inc.
3. Apr. 2018	II	Lack of Processing Controls.	Kroger Specialty Pharmacy, Inc.
3. Apr. 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

Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.

Registrierungsstatus

Einige Produkte von Allegiant Health sind nicht für die Anwendung am Menschen FDA-registriert. Für nicht registrierte Substanzen (Peptide, SARMs ohne Humanzulassung) existiert kein legitimer Anbieter für die Anwendung am Menschen. Das Fehlen eines Bezugswegs ist die Sicherheitsinformation.