Class II · Moderate risk Terminated
Conzerol zero molluscum contagiosum
Reason CGMP deviations
FDA Drug Recalls
17,898 recalls, newest first
Class III · Low risk Terminated
Triamterene and Hydrochlorothiazide Capsules
Reason Failed Impurity/Degradation Specifications
Class III · Low risk Terminated
Triamterene and Hydrochlorothiazide Capsules
Reason Failed Impurity/Degradation Specifications
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 Terminated
Timolol-Latanoprost
Reason Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
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 Terminated
Moxifloxacin Ophthalmic Solution
Reason cGMP deviation: discontinue of stability support for product.
Class II · Moderate risk Terminated
Carvedilol Tablets
Reason Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Class III · Low risk Terminated
Susvimo
Reason Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.
Class II · Moderate risk Terminated
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg
Reason Presence of Foreign Substance
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: