Agency classClass IIOur severity:High FDA (Drugs)·D-0945-2022·Announced 2022-06-01

FDA Recalls Phenylephrine 1 mg/mL Vials for Lack of Sterility Assurance

Olympia Compounding Pharmacy is recalling 9,102 vials of Phenylephrine 1 mg/mL due to lack of assurance of sterility. The affected vials were distributed nationwide in the United States, 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: FDA Class II injectable drug with potential for serious infection due to sterility assurance failure, though no illnesses have been reported. Meets the rubric criterion: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Olympia Compounding Pharmacy dba Olympia Pharmaceuticals is recalling 9,102 multi-dose vials of Phenylephrine 1 mg/mL (NDC 73198-0021-05) due to lack of assurance of sterility.

The recalled product includes two lots: K41016 with a beyond-use date of 11/16/2022, and A24025-22 with a beyond-use date of 1/25/2023. These vials were distributed nationwide in the United States, Puerto Rico, and the US Virgin Islands.

Customers who have received these recalled vials should contact Olympia Compounding Pharmacy or their healthcare provider for guidance. Any adverse events related to use of the recalled product should be reported to the FDA.

The recalled product

Product: Phenylephrine 1 mg/mL, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0021-05.
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Category: Drug
Hazard: sterility-failure
contamination
Affected units: 9,102

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)

Lots: K41016 BUD: 11/16/2022 and A24025-22 BUD: 1/25/2023

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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