FDA Recalls Compounded Drug Due to Manufacturing Monitoring Deviations
Olympia Compounding Pharmacy is recalling SB-4 due to manufacturing quality control failures. The company did not properly investigate environmental and personnel monitoring problems that occurred before 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 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 a compounded pharmaceutical product where manufacturing quality control failures created a potential for contamination. Although no illnesses or injuries have been reported, the product represents a risk-of-harm situation meeting the criterion for High severity.
Plain-English summary
Olympia Compounding Pharmacy is recalling SB-4, a compounded injectable medication supplied in 10 mL multi-dose vials (National Drug Code 73198-0023-10). Approximately 1,740 vials have been distributed nationwide.
The recall was issued due to Current Good Manufacturing Practice (CGMP) violations. Prior to October 1, 2021, the manufacturer failed to properly investigate instances when environmental and personnel monitoring levels exceeded established action limits. These monitoring processes are essential for ensuring the safety and sterility of compounded medications.
The affected lot numbers are E41C18, E41D18, G42D20, and G42B20, with beyond-use dates ranging from May to July 2022. Patients and healthcare providers should not use this product. Anyone holding affected product should contact Olympia Compounding Pharmacy or their healthcare provider for guidance.
The recalled product
- Product
- SB-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 40 mcg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0023-10.
- Category
- Drug — Compounded Injectable
- Affected units
- 1,740
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: E41C18 BUD: 5/18/2022
- E41D18 BUD: 5/18/2022
- G42D20 BUD: 7/20/2022
- G42B20 BUD: 7/20/2022
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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