Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.
Amneal Pharmaceuticals
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
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Amneal Pharmaceuticals
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
CGMP Deviations: Presence of NDMA impurity detected in product.
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Pacira Pharmaceuticals
Sub Potent Drug: Out of Specification (OOS)
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
AuroMedics Pharma
Discoloration; Hazy solution found in one vial instead of a clear solution.
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Microbial contamination of non-sterile product.
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules
Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass particules