Prescription and over-the-counter medications
Sanofi-Aventis U.S.
CGMP Deviations: Presence of NDMA impurity detected in product.
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content.
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Crystallization: Presence of visible particulate matter.
Crystallization: Presence of visible particulate matter.
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Presence of Foreign Substance: Foreign material found inside the vial.
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Crystallization: Presence of visible particulate matter.
AuroMedics Pharma
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Preferred Pharmaceuticals
Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
New Vitalis Pharmacy LLC
Lack of sterility assurance.
Altaire Pharmaceuticals
Lack of Assurance of Sterility
Altaire Pharmaceuticals
Lack of Assurance of Sterility
Altaire Pharmaceuticals
Lack of Assurance of Sterility
Altaire Pharmaceuticals
Lack of Assurance of Sterility