Class II · Moderate risk
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
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Class II · Moderate risk
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ketamine Injection
Lack of Assurance of Sterility
Class II · Moderate risk
FentaNYL 50 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Succinylcholine Cl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
PHENYLephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Pyrazinamide
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk
Ketotifen Fumarate 0.025 %
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk
Tropicamide Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Ropivacaine Hydrochloride Injection USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Pilocarpine Hydrochloride Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Olopatadine HCl Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Midazolam Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Calcitriol Injection 2 mcg/mL
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Amantadine Hydrochloride Oral Solution USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
XOPENEX (levalbuterol HCl)
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Vitamin D Supplement Drops
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Valproic Acid Oral Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Tropicamide Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Trihexyphenidyl Hydrochloride Oral Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Tobramycin Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Tobramycin Inhalation Solution USP
CGMP Deviations: Firm went out of business and could no longer continue stability studies.