Class II · Moderate risk
Sertraline Tablets
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
FDA Drug Recalls
206 recalls · Class II, newest first
Class II · Moderate risk
Oxygen
cGMP Deviations
Class II · Moderate risk
Strong Iodine Solution U.S.P.
CGMP Deviations: Recall due to the absence of USP CGMP compendial requirements.
Class II · Moderate risk
Integrity Biochem HSC 70-VA
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Class II · Moderate risk
Integrity Biochem HSC70-LV
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Class II · Moderate risk
Integrity Biochem HSC 70-LM
CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
Class II · Moderate risk
Gynazole-1
Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product rather than Hydrophobic Colloidal Silica as required by the manufacturing process.
Class II · Moderate risk
Dr. Berne's MSM DROPS 5% Solution
CGMP Deviations
Class II · Moderate risk
Dr. Berne's Organic Castor Oil Eye Drops
CGMP Deviations
Class II · Moderate risk
Dr. Berne's MSM MIST 15% Solution
CGMP Deviations
Class II · Moderate risk
Dr. Berne's MSM DROPS 15% Solution
CGMP Deviations
Class II · Moderate risk
Lugol's (Strong Iodine Solution USP)
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
AstrinGyn (Ferric Subsulfate)
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
activator concentrate
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
Unguentine Ointment
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
Alcolado Relampago
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
Yager's Liniment
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
Blis-To-Sol Liquid
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
Helix CBD Clinical Cream
CGMP Deviations
Class II · Moderate risk
Helix CBD Therapy Cream
CGMP Deviations
Class II · Moderate risk
Helix Tri-Active Therapy Cream
CGMP Deviations
Class II · Moderate risk
Helix Pain Relieving Cream
CGMP Deviations
Class II · Moderate risk
Protex Foaming Hand Sanitizer
CGMP Deviations
Class II · Moderate risk
Rufinamide Tablets
cGMP deviations: Batch was released prior to approval.
Class II · Moderate risk
Rufinamide Tablets
cGMP deviations: Batch was released prior to approval.