Avicel PH- 101 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
18,003 recalls, newest first
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
CGMP Deviations: All other lots of eye drops are being recalled due to CGMP Deviations because they were manufactured in the same facility under the same conditions as the lots found to be contaminated.
Non-Sterility: FDA analysis found unopened products to have bacterial contamination.
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Subpotent Drug
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Subpotent Drug: Low assay result observed during long-term stability testing.
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.