Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
PACIRA PHARMACEUTICALS
Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Sub Potent Drug: Out of Specification (OOS)
Subpotent; bupivacaine