FDA Drug recall D-0814-2022
RE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Con…
- FDA Drug
- Class II
- terminated
- Published 2022-05-04
On 2022-05-04 the FDA classified a Class II recall of RE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Con… 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-0814-2022 |
| 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
RE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0016-10.
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: E42G11 BUD: 5/11/2022, H41003 BUD: 8/3/2022; H41B03 BUD: 8/3/2022 |
|---|
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-0814-2022%22
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