Alprostadil Injectable Drug Recalled for Manufacturing Quality Control Deviations
Olympia Compounding Pharmacy is recalling 460 vials of Alprostadil 80 mcg/mL due to manufacturing quality control deviations related to improper investigation of environmental and personnel monitoring excursions prior to October 2021.
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: This is an FDA Class II recall based on manufacturing quality control deviations. No illnesses, injuries, or deaths have been reported. The recall is precautionary in nature, based on procedural failures in manufacturing monitoring rather than direct evidence of product harm.
Plain-English summary
Olympia Compounding Pharmacy is recalling 460 vials of PGE-2 (Alprostadil 80 mcg/mL) nationwide due to manufacturing quality control deviations. The drug is a prescription injectable medication.
The recall was issued because, prior to October 1, 2021, environmental and personnel monitoring excursions exceeded the established Out of Action Limit (OOAL) but were not properly investigated by the manufacturer. This represents a deviation from Current Good Manufacturing Practice (CGMP) requirements.
The affected product is Lot F48102 with a Beyond Use Date of June 2, 2022, distributed nationwide in the United States.
Patients should speak with their healthcare provider or pharmacist if they have questions about this medication. Healthcare providers and pharmacies should stop distribution of affected vials and arrange return to the manufacturer.
The recalled product
- Product
- PGE-2, Alprostadil 80 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0029-10.
- Category
- Drug — Injectable / Prescription
- Affected units
- 460
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 (1)
- Lot: F48102 BUD: 6/2/2022
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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