Class II · Moderate risk Ongoing
Pin-Away PYRENTAL PAMOATE
Reason CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
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Class II · Moderate risk Ongoing
Colic Calm
Reason CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Ongoing
Safe tussin DM
Reason CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk Ongoing
VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
FentaNYL 500 mcg
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Ketamine Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
FentaNYL 50 mcg/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Succinylcholine Cl Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
PHENYLephrine HCl Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Pyrazinamide
Reason 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 Ongoing
Ketotifen Fumarate 0.025 %
Reason 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 Ongoing
Tropicamide Ophthalmic Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Ropivacaine Hydrochloride Injection USP
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Pilocarpine Hydrochloride Ophthalmic Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Pilocarpine Hydrochloride Ophthalmic Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.