FDA Recalls Olympia Alprostadil 150 mcg/mL Injectable Vials for Sterility Concerns
Olympia Compounding Pharmacy is recalling PGE-3 Alprostadil 150 mcg/mL multi-dose injectable vials nationwide due to lack of assurance of sterility. The recall involves 421 vials from lot L24508.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II drug recall for a sterility assurance failure in an injectable pharmaceutical. Sterility is critical for injectable products to prevent serious infections. The source contains no reports of illnesses or injuries, classifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Olympia Compounding Pharmacy dba Olympia Pharmacy is recalling PGE-3 Alprostadil 150 mcg/mL, Multi-Dose 10 mL vials (NDC 73198-0030-10) due to lack of assurance of sterility.
The affected product is an injectable pharmaceutical. The recall was initiated because the manufacturer cannot guarantee that the vials meet required sterility standards, which is essential for injectable products.
The recall affects 421 vials from lot L24508 (beyond-use date 12/8/2022) distributed nationwide in the USA, Puerto Rico, and the U.S. Virgin Islands. Patients and healthcare providers who have received this medication should contact Olympia Compounding Pharmacy or their healthcare provider with any questions or concerns.
The recalled product
- Product
- PGE-3 Alprostadil 150 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0030-10.
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Hazard
- lack-of-sterility-assurance
- contamination-risk
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: L24508 BUD: 12/8/2022
Distribution
Distributed nationwide across the United States.
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