Class II · Moderate risk Terminated
Ketorolac Trom 30 Mg/Ml Inj
Reason Crystallization
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Haloperidol Decanoate Injection
Reason Lack of Assurance of Sterility; due to leaking vials
Class II · Moderate risk Terminated
Haloperidol Decanoate Injection
Reason Lack of Assurance of Sterility; due to leaking vials
Class II · Moderate risk Terminated
Amlodipine Besylate Tablets USP
Reason Failed tablet specifications: One lot was found to contain oversized tablets.
Class II · Moderate risk Terminated
Phen 15 mg - Topri 92 mg SR Cap
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Hydrocortisone 1.6 mg/0.5 mL Susp
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Nystatin 50
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Coconut Oil Suppository
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Cyclandelate 200 mg Caps
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Triest 5 mg - Progest 150 mg Capsule
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Colchicine 0.6 mg Caps
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Lansoprazole 3 mg/mL Susp
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Thymol 2% Solution
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Methenamine/Phenyl Salicylate Capsule
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
DNCB 0.3% Ointment
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Ciprodex with Amphoteracin B
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Sildenafil 10 mg/1 mL Susp
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Verapamil HCl 15% Topical Cream
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Phenylephrine 0.5% Solution
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Hydroxyurea 100 mg/1 mL Susp
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Renacidin Irrigation Solution
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Nifedipine 0.2% - Lidocaine 2% Jelly
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Pyridoxine 100 mg/1 mL Syrup
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Folic Acid 2 mg/1 mL Susp
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Fortified Vancomycin 25 mg/1 mL Opth Drops
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.