Compounded ST-2 pharmaceutical vials recalled for manufacturing process deviations
Olympia Compounding Pharmacy is recalling 2005 vials of ST-2, a compounded pharmaceutical, nationwide due to manufacturing practice deviations and failures to properly investigate environmental and personnel monitoring excursions.
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 with no reported illnesses or injuries and a theoretical hazard from manufacturing control failures. Per the rubric, this qualifies as 'High' severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Olympia Compounding Pharmacy is recalling 2005 vials of ST-2, a compounded pharmaceutical containing papaverine 30 mg/mL, phentolamine 3 mg/mL, and alprostadil 100 mcg/mL in 10 mL multi-dose vials (NDC 73198-0012-10). The product was distributed nationwide in the USA. Affected lot numbers and their beyond-use dates are: F41C21 (6/21/2022), G42013 (7/13/2022), H41C31 (8/31/2022), and F41D21 (6/21/2022).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Prior to October 1, 2021, environmental and personnel monitoring procedures at the manufacturer showed excursions that exceeded the Out of Action Limit (OOAL) threshold. These excursions were not properly investigated, representing lapses in manufacturing oversight and quality assurance.
The recalled product
- Product
- ST-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 100 mcg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0012-10.
- Category
- Drug — Compounded Pharmaceutical
- Affected units
- 2,005
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 (4)
- Lots: F41C21 BUD: 6/21/2022
- G42013 BUD: 7/13/2022
- H41C31 BUD: 8/31/2022
- F41D21 BUD: 6/21/2022
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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