FDA Drug recall D-1084-2018
PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue…
- FDA Drug
- Class II
- terminated
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class II recall of PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue… by Ranier S Compounding Laboratory, citing lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1084-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-25 |
| Published | 2018-08-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ranier S Compounding Laboratory |
| Distribution | PA |
Product
PR/PA/PH (Prostaglandin/Papaverine/Phentolamine) Injection, 10mcg/30/1mg/mL, 10 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Reason
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Identifiers
| code_info | All lots within expiry |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1084-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.