PGE-1 — Class II drug recall D-0817-2022
Terminated recall by Olympia Compounding Pharmacy dba Olympia Pharmacy, reported 2022-05-04, distributed nationwide. CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) e
| Recall number | D-0817-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympia Compounding Pharmacy dba Olympia Pharmacy, Orlando, FL, United States |
| Recall initiated | 2022-04-04 |
| Classified | 2022-04-27 |
| Reported by FDA | 2022-05-04 |
| Terminated | 2024-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 821 vials |
| Reason classes | cgmp |
| NDC | 73198-0028-10 |
| Lot numbers | F47B30, F47C30, I24028 |
| Expiration dates | 2022-06-30, 2022-09-28 |
Product
PGE-1, Alprostadil 40 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0028-10.
Reason for recall
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0817-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.