FDA Drug recall D-0803-2022
NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convo…
- FDA Drug
- Class II
- terminated
- Published 2022-05-04
On 2022-05-04 the FDA classified a Class II recall of NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convo… by Olympia Compounding Pharmacy, citing CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0803-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-04-04 |
| Published | 2022-05-04 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Olympia Compounding Pharmacy |
| Distribution | US |
Product
NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0009-10
Reason
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Identifiers
| code_info | Lots: I24C28 BUD: 9/28/2022, D41I19 BUD: 4/19/2022, F41321 BUD: 6/21/2022, I24128 BUD: 9/28/2022 |
|---|
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-0803-2022%22
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