Class II · Moderate risk Completed
Oxybutynin Chloride Extended-Release Tablet USP
Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Completed
Oxybutynin Chloride Extended-Release Tablet USP
Reason Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
Class II · Moderate risk Terminated
Strong Iodine Solution U.S.P.
Reason CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Class II · Moderate risk Terminated
Integrity Biochem HSC 70-VA
Reason CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Class II · Moderate risk Terminated
Integrity Biochem HSC70-LV
Reason CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Class II · Moderate risk Terminated
Integrity Biochem HSC 70-LM
Reason CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Class II · Moderate risk Terminated
Montelukast Sodium Tablets
Reason Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Class II · Moderate risk Ongoing
Certain Over-The-Counter
Reason CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
Class II · Moderate risk Terminated
Clinical TREAT Antifungal Powder
Reason CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
Class II · Moderate risk Terminated
Foscarnet Sodium 2.4mg/0.1 mL solution for injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Tropi-Phen
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lidocaine HCl 4% ophthalmic solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Calcium chloride Solution for Intravenous Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
TPC Drops
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Cefuroxime 4mg /0.4 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Moxifloxacin in Balanced Salt Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Tropi-Phen
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Calcium Gluconate 2.5% solution for inhalation
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Calcium Gluconate Ophthalmic Irrigation Solution 1%
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Endophth Kit
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Bevacizumab 1.25 MG/0.05 ML Solution for Injection
Reason Lack of Assurance of Sterility