Drug product
Triple P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.008/22.5/0.83 mg/mL, packaged in a) 5 mL and b) 10 mL vials, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
D-1083-2018
Product summary
- Event
- Event 80633
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 1 vial; b) 1 vial
- Official record key
drug-enforcement:D-1083-2018
Official wording
Reason: Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Code information: All lots within expiry
Distribution pattern: Product was distributed within the state of Pennsylvania.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility