CGMP Deviations
All Recalls
95,018 total recalls in our database
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
Failed Dissolution Specifications
Presence of Particulate Matter: Due to production issues
Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054
Teva Pharmaceuticals USA
Failed Dissolution Specifications
CGMP Deviations
Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11
Teva Pharmaceuticals USA
Failed Dissolution Specifications
CGMP Deviations
CGMP Deviations
CGMP Deviations
Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.
Teva Pharmaceuticals USA
Failed Dissolution Specifications
CGMP Deviations
SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
ANTHONY TRINH, 123Herbals
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
Olympus Corporation of the Americas
Potential for rubber fragment detachment during use.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.