Agency classClass IIOur severity:High FDA (Drugs)·D-0909-2022·Announced 2022-06-01

FDA Recalls Compounded Papaverine Injection Due to Sterility Assurance

Olympia Compounding Pharmacy is recalling T-105 Papaverine injection vials due to lack of assurance of sterility. The recall affects 3,312 vials 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: This is an FDA Class II recall of an injectable compounded drug with a theoretical sterility hazard and no reported illnesses. Risk-of-harm products without reported injuries are rated High per the severity rubric.

Plain-English summary

Olympia Compounding Pharmacy dba Olympia Pharmacy is recalling T-105 Papaverine 30 mg/mL, Phentolamine 1 mg/mL, and PGE 10 mcg/mL injection due to lack of assurance of sterility. The recall includes 2.5 mL multi-dose vials (NDC 73198-0005-03) and 5 mL multi-dose vials (NDC 73198-0005-05).

The affected lot numbers are K41J09 and K41I09 with a beyond-use date of November 9, 2022, and lot B24B22-22 with a beyond-use date of February 22, 2023. A total of 3,312 vials have been distributed nationwide in the United States, Puerto Rico, and the U.S. Virgin Islands.

Patients and healthcare providers with questions about this recall should contact their healthcare provider or the FDA.

The recalled product

Product: T-105 Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL, Packaged as a) 2.5 mL Multi-Dose vial NDC 73198-0005-03; b) 5 mL Multi Dose vial, NDC 73198-0005-05, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Category: Drug — Compounded Injection
Hazard: contamination-risk
Affected units: 3,312

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: K41J09
K41I09 BUD: 11/9/2022
B24B22-22 BUD: 2/22/2023

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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Same hazard · contamination risk