Drug product
PRO/PA/PH/AT 18mcg/1.8mg/ (Prostaglandin//Papaverine/Phentolamine/Atropine) Injection, 18mcg/1.8 mg/0.2 mg/0.02 mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
D-1092-2018
Product summary
- Event
- Event 80633
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 vial
- Official record key
drug-enforcement:D-1092-2018
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