Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Class II · Moderate risk Ongoing
Adam's Polishes ALCOHOL BASED HAND SANITIZER
Reason CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class II · Moderate risk Ongoing
Tobramycin Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Tobramycin Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Sodium Chloride Ophthalmic Ointment
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Proparacaine Hydrochloride Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Proparacaine Hydrochloride Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Paremyd
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Olopatadine HCl Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Olopatadine HCl Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Olopatadine HCl Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Olopatadine HCL Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Olopatadine HCl Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Ofloxacin Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Neomycin and Polymyxin B Sulfates
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Moxifloxacin Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Lidocaine Hydrochloride Jelly USP
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Levofloxacin Ophthalmic Solution 0.5%
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Ketorolac Tromethamine Ophthalmic Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
GONAK Hypromellose Ophthalmic Demulcent Solution
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Erythromycin Ophthalmic Ointment USP
Reason CGMP Deviations:
Class II · Moderate risk Ongoing
Erythromycin Ophthalmic Ointment USP 0.5%
Reason CGMP Deviations: