Class III · Low risk
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
Phenytoin Sodium Injection
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class III · Low risk
Phenytoin Sodium Injection
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class II · Moderate risk
PF-Neostigmine Methylsulfate Injection
CGMP Deviations: Potential for cross contamination due to product carry over.
Class II · Moderate risk
PF-Labetalol HCl Injection
CGMP Deviations: Potential for cross contamination due to product carry over.
Class II · Moderate risk
Phenoxybenzamine Hydrochloride Capsules
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Conzerol zero molluscum contagiosum
CGMP deviations
Class III · Low risk
Triamterene and Hydrochlorothiazide Capsules
Failed Impurity/Degradation Specifications
Class III · Low risk
Triamterene and Hydrochlorothiazide Capsules
Failed Impurity/Degradation Specifications
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Class II · Moderate risk
Timolol-Latanoprost
Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
Class II · Moderate risk
Adam's Polishes ALCOHOL BASED HAND SANITIZER
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
Adam's Polishes ALCOHOL BASED HAND SANITIZER
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
Moxifloxacin Ophthalmic Solution
cGMP deviation: discontinue of stability support for product.
Class II · Moderate risk
Carvedilol Tablets
Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Class III · Low risk
Susvimo (ranibizumab injection)
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
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg
Presence of Foreign Substance
Class II · Moderate risk
Tobramycin Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Tobramycin Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Sodium Chloride Ophthalmic Ointment
CGMP Deviations:
Class II · Moderate risk
Proparacaine Hydrochloride Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Proparacaine Hydrochloride Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Class II · Moderate risk
Olopatadine HCl Ophthalmic Solution
CGMP Deviations: