Class II · Moderate risk Terminated
Cardioplegia Solution
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
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Class II · Moderate risk Terminated
Microplegia
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class III · Low risk Terminated
Fentanyl Buccal Tablets CII
Reason Labeling: Incorrect or Missing Package Insert
Class III · Low risk Terminated
Fentanyl Buccal Tablets CII
Reason Labeling: Incorrect or Missing Package Insert
Class III · Low risk Terminated
Fentanyl Buccal Tablets CII
Reason Labeling: Incorrect or Missing Package Insert
Class III · Low risk Terminated
Fentanyl Buccal Tablets CII
Reason Labeling: Incorrect or Missing Package Insert
Class III · Low risk Terminated
Fentanyl Buccal Tablets CII
Reason Labeling: Incorrect or Missing Package Insert
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.
Class II · Moderate risk Ongoing
Olopatadine HCl Ophthalmic Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Midazolam Injection
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Calcitriol Injection 2 mcg/mL
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Amantadine Hydrochloride Oral Solution USP
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Xopenex
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Vitamin D Supplement Drops
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Valproic Acid Oral Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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
Trihexyphenidyl Hydrochloride Oral Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Tobramycin Ophthalmic Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Tobramycin Inhalation Solution USP
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Sulfamethoxazole & Trimethoprim Oral Suspension USP
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Sufenta
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.