Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Alvogen
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Class I - Dangerous
Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low)
Failed dissolution specifications
Class I - Dangerous
Failed dissolution specifications
Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class I - Dangerous
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class I - Dangerous
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class I - Dangerous
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class I - Dangerous
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class I - Dangerous
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class I - Dangerous
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class I - Dangerous
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class I - Dangerous
Failed Dissolution Specification; 6 month time point
Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.