Prescription Injectable ST-1 Recalled for Manufacturing Process Control Failures
Olympia Compounding Pharmacy is recalling 525 vials of ST-1, a prescription injectable medication, due to manufacturing control failures.
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 3/5 (High).
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 recall for a parenteral (injectable) medication where manufacturing monitoring investigations were not properly conducted. No illnesses, injuries, or deaths have been reported. The hazard—potential quality and sterility issues due to inadequate manufacturing oversight—is theoretical. Class II classification indicates health hazard, but absence of reported harm limits the score to 3 (High) per the rubric.
Plain-English summary
Olympia Compounding Pharmacy is recalling ST-1, a prescription injectable medication in 10 mL multi-dose vials. Each vial contains papaverine 30 mg/mL, phentolamine 1.5 mg/mL, and alprostadil 50 mcg/ml. This medication is used to treat erectile dysfunction. The recall affects 525 vials that were distributed nationwide in the United States.
The recall is due to Current Good Manufacturing Practice (GMP) deviations. Prior to October 1, 2021, the pharmacy did not properly investigate instances where environmental monitoring and personnel monitoring readings exceeded acceptable limits. These monitoring excursions should have triggered investigations to ensure product quality and safety, but were not handled in compliance with FDA manufacturing standards.
The affected lots are H24F03 and H24E03, both with expiration dates of August 3, 2022. Patients who have been prescribed this medication should consult with their healthcare provider or pharmacist to determine whether they received product from these recalled lots and to discuss appropriate next steps.
The recalled product
- Product
- ST-1, Papaverine 30 mg/mL . Phentolamine 1.5 mg/mL . Alprostadil 50 mcg/ml, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0011-10.
- Category
- Drug — Compounded Injectable
- Affected units
- 525
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 (2)
- Lots: H24F03 BUD: 8/3/2022
- H24E03 BUD: 8/3/2022
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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