Failed Dissolution Specifications.
Strides Pharma
Class I - Dangerous
Presence of foreign substance: Presence of Benzene.
Class I - Dangerous
Presence of foreign substance: Presence of Benzene.
Failed Dissolution Specifications
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Failed Dissolution Specifications
Failed Moisture Limits
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.