D-1092-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 22, 2018
- Initiation Date
- July 25, 2018
- Termination Date
- September 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 vial
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Distribution Pattern
Product was distributed within the state of Pennsylvania.
Code Information
All lots within expiry