RE-1 Compounded Injectable Medication Recalled Due to Sterility Assurance Issues
Olympia Compounding Pharmacy is recalling 482 vials of RE-1 (Papaverine, Phentolamine, Alprostadil) injectable medication due to lack of sterility assurance. Product was distributed nationwide in the USA, 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 is an FDA Class II recall without reported illnesses or injuries. The product is a risk-of-harm injectable medication, and the lack of sterility assurance presents a potential infection risk, meeting the criteria for a High severity rating.
Plain-English summary
RE-1 is a compounded injectable medication containing Papaverine 30 mg/mL, Phentolamine 3 mg/mL, and Alprostadil 200 mcg/mL. Olympia Compounding Pharmacy has recalled this product due to lack of assurance of sterility.
The recall affects 482 vials distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands. The affected vials are available in two sizes: 2.5 mL Multi Dose vials (NDC 73198-0015-03) and 10 mL Multi Dose vials (NDC 73198-0015-10). The affected lot numbers are B24E09-22 and B24F09-22, both with BUD 02/09/2023.
Patients and healthcare providers who have these vials should stop using them immediately and contact their pharmacist or healthcare provider for guidance. Non-sterile injectable medications can pose a serious risk of infection.
The recalled product
- Product
- RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0015-03; b) 10 mL Multi Dose vial, NDC 73198-0015-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Injectable / Compounded
- Hazard
- non-sterile
- 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: B24E09-22 BUD: 02/09/2023
- B24F09-22 BUD: 02/09/2023
Distribution
Distributed nationwide across the United States.
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