Class II · Moderate risk Terminated
EPINEPHIrine in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
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Class II · Moderate risk Terminated
Succinylcholine Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sodium Bicarbonate in 5% Dextrose Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
PHENYLepherine HCL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
EPINEPHrine
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
NOREPINEPHRINE 4 mg per 250 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
dilTIAZem HCl 125 mg per 125 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Morphine Sulfate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Midazolam in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Fexofenadine HCl
Reason Failed dissolution specifications
Class III · Low risk Terminated
Allergy Relief D Fexofenadine HCl
Reason Failed dissolution specifications
Class III · Low risk Terminated
Allergy Relief D Fexofenadine HCl
Reason Failed dissolution specifications
Class III · Low risk Terminated
12 HR Allergy & Congestion Relief Fexofenadine HCl
Reason Failed dissolution specifications
Class III · Low risk Terminated
Antihistamine & Nasal Decongestant
Reason Failed dissolution specifications
Class III · Low risk Terminated
Antihistamine & Nasal Decongestant
Reason Failed dissolution specifications
Class III · Low risk Terminated
Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended…
Reason Failed dissolution specifications
Class III · Low risk Terminated
Allergy & Congestion Relief Allergy Relief D
Reason Failed dissolution specifications
Class III · Low risk Terminated
Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl…
Reason Failed dissolution specifications
Class II · Moderate risk Terminated
Buprenorphine HCl
Reason Crystallization; identified as Buprenorphine free base
Class II · Moderate risk Terminated
Hand Sanitizer Foam
Reason Defective Container: Customer complaints for leaking bottles and dispensing issues.
Class II · Moderate risk Terminated
Clindamycin and Benzoyl Peroxide Gel
Reason Superpotent Drug
Class II · Moderate risk Terminated
Flocinolone Acetonide 0.01% Topical Oil
Reason Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Class II · Moderate risk Terminated
Flocinolone Acetonide 0.01% Topical Oil
Reason Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Class II · Moderate risk Terminated
Cefixime Capsules 400 mg
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Acetaminophen Oral Suspension
Reason cGMP Deviations: Product manufactured with contaminated raw ingredient.