Alprostadil Injection Recalled Over Manufacturing Quality Control Failures
Olympia Compounding Pharmacy recalled PGE-3 Alprostadil 150 mcg/mL injection due to manufacturing facility failure to properly investigate environmental and personnel monitoring excursions.
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 a risk-of-harm product where no injury has been reported. The compounding pharmacy's failure to investigate environmental and personnel monitoring excursions creates a potential risk of contamination or sterility failure in sterile injectable products.
Plain-English summary
Olympia Compounding Pharmacy has recalled PGE-3 (Alprostadil 150 mcg/mL, 10ml multi-dose vial). The recall affects 410 vials with lot number G24C19 (BUD: 7/19/2022) that were distributed nationwide in the USA.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. Prior to October 1, 2021, the compounding facility failed to properly investigate environmental and personnel monitoring excursions that exceeded the facility's Out of Action Limit (OOAL). Failure to investigate these excursions prevents verification that the manufacturing environment remained suitable for producing sterile injectables.
Patients who received this product from the affected lot should contact their healthcare provider or pharmacy.
The recalled product
- Product
- PGE-3, Alprostadil 150 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0030-10.
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Hazard
- cgmp-violation
- potential-contamination
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: G24C19 BUD: 7/19/2022
Distribution
Distributed nationwide across the United States.
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