Agency classClass IIOur severity:High FDA (Drugs)·D-0927-2022·Announced 2022-06-01

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units: 1,703

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.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 53 recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 53 products in this recall →

Same manufacturer · Olympia Compounding Pharmacy dba Olympia Pharmacy

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