FDA Drug recall D-0901-2022
SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05
- FDA Drug
- Class II
- completed
- Published 2022-06-01
On 2022-06-01 the FDA classified a Class II recall of SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05 by Olympia Compounding Pharmacy, citing lack of assurance of sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0901-2022 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-05-09 |
| Published | 2022-06-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Olympia Compounding Pharmacy |
| Distribution | US |
Product
SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Reason
Lack of assurance of sterility.
Identifiers
| code_info | Lots: L24D14, L24C14 BUD: 12/14/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0901-2022%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.