Agency classClass IIOur severity:High FDA (Drugs)·D-0940-2022·Announced 2022-06-01

Injectable pharmaceutical vial recalled due to sterility assurance failure

Olympia Compounding Pharmacy is recalling an injectable medication vial due to lack of sterility assurance. The recall affects 606 vials distributed nationwide, Puerto Rico, and US Virgin Islands.

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 a risk-of-harm product (injectable medication) where sterility assurance is critical to patient safety. While classified as FDA Class II with no reported illnesses or confirmed contamination, the potential for serious infection from use of non-sterile injectables warrants a High severity rating.

Plain-English summary

Olympia Compounding Pharmacy dba Olympia Pharmacy is recalling NB-343, a multi-dose 10 mL injectable vial containing papaverine 30 mg/mL, phentolamine 3 mg/mL, and PGE 30 mcg/mL (NDC 73198-0010-10). The recall is due to lack of assurance of sterility.

This product was distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands. The affected lot is L24C08 with a beyond-use date of December 8, 2022.

Healthcare providers and patients who have received this product should not use remaining stock and should contact their healthcare provider for guidance regarding any doses that may have been administered.

The recalled product

Product: NB-343 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 30 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0010-10.
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Category: Drug — Injectable Medication
Hazard: sterility-assurance
contamination-risk
infection-risk
Affected units: 606

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: L24C08 BUD: 12/8/2022

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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