FDA Drug recall D-0722-2022
SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-05
- FDA Drug
- Class III
- terminated
- Published 2022-03-30
On 2022-03-30 the FDA classified a Class III recall of SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-05 by Olympia Compounding Pharmacy, citing sub Potent.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0722-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-03-08 |
| Published | 2022-03-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Olympia Compounding Pharmacy |
| Distribution | US |
Product
SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-05; b) 10 mL Multi-dose vial NDC 73198-0023-10, Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 2% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, Conroy Rd., Ste. 155, Orlando, FL 32835
Reason
Sub Potent
Identifiers
| code_info | Lots: a) E41C18 Exp. 5/18/22; b) E41D18 Exp. 5/18/22 |
|---|
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-0722-2022%22
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