Compounded Injectable Drug Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling SB-5, a multi-dose injectable medication, due to lack of assurance of sterility. The product was distributed nationwide; patients should contact their healthcare provider immediately.
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: FDA Class II classification with lack of sterility assurance on an injectable product represents a risk-of-harm scenario. No illnesses or injuries are reported in the source text, placing this at the High level per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympia Compounding Pharmacy is recalling SB-5 (Papaverine 30 mg/mL, Phentolamine 3 mg/mL, PGE 50 mcg/mL), a multi-dose 10 mL injectable vial. The recall is due to a lack of assurance of sterility.
The recalled medication was distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands. The affected lot is B24D02-22, with a Beyond Use Date of February 2, 2023. Approximately 75 vials are involved in this recall.
Because sterility cannot be assured, this injectable medication poses a risk to patients if used. Those who have received this product should immediately contact their healthcare provider or pharmacist to discuss whether they may be affected and what precautions or monitoring may be needed.
Do not use any vials from the recalled lot. Return the product to your pharmacy or healthcare provider for proper disposal.
The recalled product
- Product
- SB-5 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 50 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0024-10
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-assurance
- infection-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: B24D02-22 BUD: 02/02/2023
Distribution
Distributed nationwide across the United States.
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