PGE-1 Alprostadil Injection Recalled for Manufacturing Process Deviations
Olympia Compounding Pharmacy is recalling 821 vials of PGE-1 Alprostadil 40 mcg/mL injection nationwide. The recall is due to Current Good Manufacturing Practice deviations in environmental and personnel monitoring procedures that were not properly investigated.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall due to CGMP deviations in environmental and personnel monitoring. Prior to October 1, 2021, monitoring excursions were not properly investigated per manufacturing requirements.
Plain-English summary
Olympia Compounding Pharmacy is recalling 821 vials of PGE-1, Alprostadil 40 mcg/mL, a prescription injection medication, due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects three lot numbers: I24028 (expiration 9/28/2022), F47C30 (expiration 6/30/2022), and F47B30 (expiration 6/30/2022), all distributed nationwide.
The FDA initiated this recall because prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated. CGMP requires proper investigation of any monitoring excursions to ensure manufacturing quality and product safety.
Patients currently using this medication should contact their healthcare provider or pharmacist immediately for guidance. Those who believe they may have received an affected vial should not use the product and should report any adverse effects to their healthcare provider or the FDA.
The recalled product
- 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.
- Category
- Drug — Injectable
- Affected units
- 821
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots: I24028 BUD: 9/28/2022
- F47C30 BUD: 6/30/2022
- F47B30 BUD: 6/30/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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