Agency classClass IIOur severity:High FDA (Drugs)·D-0929-2022·Announced 2022-06-01

Compounded Injectable Medication Recalled Due to Sterility Assurance Failure

Olympia Compounding Pharmacy is recalling 205 vials of Formula F9 injectable medication nationwide due to lack of assurance of sterility. The FDA has classified this as a Class II recall.

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: This is an FDA Class II recall of a sterile injectable medication where the manufacturer lacks assurance of product sterility. While no illnesses or injuries have been reported, the theoretical risk of infection from use of a product with unconfirmed sterility represents a significant potential harm to patients.

Plain-English summary

Olympia Compounding Pharmacy is recalling Formula F9, a compounded injectable medication supplied in multi-dose 10 mL vials (NDC 73198-0004-10). The product contains Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, and Atropine 0.01 mg/mL.

The recall was initiated because the manufacturer lacks assurance that the product meets sterility standards required for injectable medications. The affected lot is B24G02-22 with a beyond-use date of February 2, 2023.

The product was distributed nationwide throughout the United States, Puerto Rico, and the U.S. Virgin Islands. Approximately 205 vials were affected by this recall.

The recalled product

Product: Formula F9 Papaverine 0.9 mg/mL Phentolamine 0.1 mg/mL PGE 20 mcg/mL Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0004-10
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Category: Drug — Injectable / Compounded
Hazard: lack-of-sterility
infection-risk
Affected units: 205

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: B24G02-22 BUD: 2/2/2023

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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