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Manufacturer profile

Allegiant Health

Pharmaceutical company10 products tracked
10
products tracked
1,077,536
total reports
127
recalls on record
58.2%
serious overall
Products
showing 10 of 10
ProductApprovedReports ↓Top signalRecalls
—500,597Gastrointestinal haemorrhage0
kit
—
1974360,069—100
—195,216Lower respiratory tract infection1
—14,106Chronic kidney disease0
19965,686Rebound acid hypersecretion2
—728Rhinorrhoea5
—412Seasonal allergy1
—347Disease recurrence9
—301Expired product administered9
—74Hospitalisation0
Recall history · 50 on record
DateClassReasonFirm
Mar 17, 2026IILack 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
Mar 17, 2026IILack 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
Nov 22, 2024IIFailed Stability SpecificationsJubilant Draximage Inc., dba Jubilant Radiopharma
May 31, 2024IIILabeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.Washington Homeopathic Products, Inc.
Aug 2, 2023IICGMP DeviationsParker Laboratories, Inc.
Apr 26, 2023IICGMP Deviations: Firm went out of business and could no longer continue stability studies.Akorn, Inc.
Dec 23, 2022IMicrobial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.GFA Production Xiamen Co. Ltd.
Dec 23, 2022IMicrobial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.GFA Production Xiamen Co. Ltd.
Dec 23, 2022IMicrobial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.GFA Production Xiamen Co. Ltd.
Jun 23, 2022IICGMP Deviations: product held outside appropriate storage temperature conditions.Family Dollar Stores, Llc.
Jun 23, 2022IICGMP Deviations: product held outside appropriate storage temperature conditions.Family Dollar Stores, Llc.
Jun 23, 2022IICGMP Deviations: product held outside appropriate storage temperature conditions.Family Dollar Stores, Llc.
Jun 16, 2022IILack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.Jubilant Draximage Inc
Apr 13, 2022IIcGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office
Mar 18, 2022IIISubpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.Advanced Accelerator Applications USA, Inc.
Dec 3, 2021IIISubpotent Drug: Product contains less Sodium Fluoride than listed on product label.Dental Alliance Holdings LLC
Dec 3, 2021IIISubpotent Drug: Product contains less Sodium Fluoride than listed on product label.Dental Alliance Holdings LLC
Dec 3, 2021IIISubpotent Drug: Product contains less Sodium Fluoride than listed on product label.Dental Alliance Holdings LLC
Dec 3, 2021IIISubpotent Drug: Product contains less Sodium Fluoride than listed on product label.Dental Alliance Holdings LLC
Aug 24, 2021IProduct Mix-up: Incorrect diluent component included in the kit.Azurity Pharmaceuticals, Inc.
Mar 22, 2021IITemperature 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
Mar 22, 2021IITemperature 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
Mar 22, 2021IITemperature 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
Apr 21, 2020IIDefective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple VitaminsSandoz, Inc
Mar 19, 2020IIFailed Stability SpecificationsJubilant Draximage Inc
Oct 31, 2019IIMicrobial contamination of non-sterile product.Fagron, Inc
Sep 26, 2019IILabeling: 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.
May 28, 2019IILack of Processing Controls.Synthetopes Inc
May 28, 2019IILack of Processing Controls.Synthetopes Inc
Mar 25, 2019IILabeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.Lohxa LLC
Dec 11, 2018ILabeling: 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 latexAsclemed USA Inc. dba Enovachem
Nov 16, 2018IIcGMP violations noted during the firm's most recent inspection.CAO Group, Inc.
Nov 2, 2018IILabeling 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
Nov 2, 2018IILabeling 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
Nov 1, 2018IILabeling: 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
Sep 10, 2018IILack of Assurance of SterilityPharm D Solutions, LLC
Jul 20, 2018IMicrobial contaminationKing Bio Inc.
Jul 20, 2018IMicrobial contaminationKing Bio Inc.
Jul 20, 2018IMicrobial contaminationKing Bio Inc.
Jun 6, 2018IILack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.Pharmalucence, Inc.
Apr 26, 2018IILack of Assurance of SterilityCoast Quality Pharmacy LLC
Apr 10, 2018IIFailed Stability SpecificationsPharmalucence, Inc.
Apr 3, 2018IILack of Processing Controls.Kroger Specialty Pharmacy, Inc.
Apr 3, 2018IILack of Processing Controls.Kroger Specialty Pharmacy, Inc.
Sep 21, 2017IISubpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.Medline Industries Inc
Sep 21, 2017IISubpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.Medline Industries Inc
Sep 21, 2017IISubpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.Medline Industries Inc
Sep 21, 2017IISubpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.Medline Industries Inc
Sep 21, 2017IISubpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.Medline Industries Inc
Sep 21, 2017IISubpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.Medline Industries Inc

Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.

Registration status

Some products from Allegiant Health are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.