Compounded Injectable Formula F1 Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling Formula F1, a compounded injectable medication, due to lack of sterility assurance. The 1,703 vials were 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: FDA Class II recall without reported hospitalizations. Lack of sterility assurance in an injectable pharmaceutical is a risk-of-harm product where injury has not yet been reported, meeting the criteria for High (3) per the rubric.
Plain-English summary
Olympia Compounding Pharmacy dba Olympia Pharmacy is recalling Formula F1 compounded injectable medication due to lack of assurance of sterility. The product contains Papaverine 1.8 mg/mL, Phentolamine 0.2 mg/mL, Alprostadil 18 mcg/mL, and Atropine 0.02 mg/mL.
The recall affects 1,703 vials distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands. Affected product includes 2.5 mL multi-dose vials (NDC 73198-0001-03) and 10 mL multi-dose vials (NDC 73198-0001-10). Affected lots are K41C09 and K41B09 with a beyond-use date of November 9, 2022, and lot A24C19-22 with a beyond-use date of January 19, 2023.
The lack of sterility assurance in a multi-dose injectable vial creates a potential risk of microbial contamination and infection.
The recalled product
- Product
- Formula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL Alprostadil 18 mcg/mL Atropine 0.02 mg/mL, Packaged as a)2.5 mL Multi-Dose vial, NDC 73198-0001-03; b) 10 mL Multi-Dose vial, NDC 73198-0001-10; 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-failure
- 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 (3)
- Lots: K41C09
- K41B09 BUD: 11/9/2022
- and A24C19-22 BUD: 1/19/2023
Distribution
Distributed nationwide across the United States.
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