Formula F2 Compounded Injectable Medication Recalled for Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling Formula F2, a multi-ingredient injectable medication, because the manufacturer cannot assure sterility. The recall affects 72 vials distributed nationwide.
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 a Class II recall of an injectable compounded medication lacking sterility assurance. Although no illnesses have been reported, lack of sterility in injectable products represents a significant potential risk of harm, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Olympia Compounding Pharmacy is recalling Formula F2, a compounded injectable medication containing papaverine, phentolamine, alprostadil, and atropine. The recall affects 72 vials (NDC 73198-0002-10, Lot A24F19-22, BUD 1/19/2023) that were distributed nationwide in the United States, Puerto Rico, and the U.S. Virgin Islands.
The product is being recalled because the manufacturer cannot assure that the vials maintain sterility. Sterile compounded injectables require stringent manufacturing controls to prevent microbial contamination, which could pose serious health risks when administered.
Patients or healthcare providers who have received or are using this medication should not use the recalled product. Contact Olympia Compounding Pharmacy or a healthcare provider if you have questions about an alternative treatment.
The recalled product
- Product
- Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atropine 0.1 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0002-10
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- lack-of-sterility
- 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 (1)
- Lot: A24F19-22 BUD: 1/19/2023
Distribution
Distributed nationwide across the United States.
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