Olympia Compounding Pharmacy Recalls Papaverine-Phentolamine Injectable Due to Sterility Concerns
Olympia Compounding Pharmacy is recalling SB-6, a compounded injectable medication, due to lack of assurance of sterility. The recall affects 874 vials distributed nationwide, in Puerto Rico, and the US Virgin Islands.
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 FDA Class II recall involves lack of sterility assurance in an injectable medication, which poses a risk of harm. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported receive a High severity score.
Plain-English summary
Olympia Compounding Pharmacy is recalling SB-6, a compounded injectable medication containing papaverine 30 mg/mL, phentolamine 3 mg/mL, and prostaglandin E1 60 mcg/mL, packaged in 5 mL and 10 mL multi-dose vials. The recall was initiated due to lack of assurance of sterility during the manufacturing process.
The affected products were distributed nationwide throughout the United States, Puerto Rico, and the US Virgin Islands. A total of 874 vials are subject to this recall, specifically lot numbers L24D14 and L24C14, with a beyond-use date of December 14, 2022.
The recalled product
- Product
- SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-defect
- contamination-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 (2)
- Lots: L24D14
- L24C14 BUD: 12/14/2022
Distribution
Distributed nationwide across the United States.
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