Class I - Dangerous
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.
Product Mix-Up: A foreign tablet was found in bottle.
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Failed Dissolution Specifications.