Prescription Drugs

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Out of specification result observed in a dissolution test at the 9-month long term stability time point.

Failed Dissolution Specifications: results were above specification.

Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.

Lack of Assurance of Sterility

Failed Dissolution Specifications