Class II · Moderate risk Ongoing
Humatrix Microclysmic Gel
Reason CGMP Deviations: initiated due to violations of CGMP manufacturing practices
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Techni-Care Chloroxylenold 3%
Reason CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Class II · Moderate risk Ongoing
Acyclovir Sodium Injection 1
Reason Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Class II · Moderate risk Ongoing
Glycopyrrolate Tablets
Reason Failed Impurities/Degradation Specifications
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.
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 I · High risk Ongoing
Adam's Polishes ALCOHOL BASED HAND SANITIZER
Reason Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v 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: