Agency classClass IIOur severity:High FDA (Drugs)·D-0930-2022·Announced 2022-06-01

Lidocaine 2% injectable solution recalled for lack of sterility assurance

Olympia Pharmaceuticals recalled 1195 vials of Lidocaine 2% due to lack of assurance of sterility. The vials were distributed nationwide and should not be used.

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 of a sterile pharmaceutical product. While no illnesses or injuries are reported, this is a risk-of-harm product (injectable medication) where sterility failure could result in serious infection. Per the rubric, 'risk-of-harm products where injury has not yet been reported' warrant a score of 3.

Plain-English summary

Olympia Compounding Pharmacy, also known as Olympia Pharmacy, is recalling 1195 vials of Lidocaine 2% (20 mg/mL) multi-dose vials (NDC 73198-0097-30). Two lot codes are affected: Lot L246022 (beyond-use date 6/22/2022) and Lot B24208-22 (beyond-use date 8/8/2022).

The recall was initiated due to lack of assurance of sterility. Sterility is essential for injectable medications, particularly multi-dose vials used in healthcare settings.

The affected vials were distributed nationwide in the United States, Puerto Rico, and the U.S. Virgin Islands.

Patients and healthcare providers who have these vials should discontinue use and contact Olympia Compounding Pharmacy or their healthcare provider for guidance.

The recalled product

Product: Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial , Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0097-30
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Category: Drug — Injectable / Local Anesthetic
Hazard: lack-of-sterility
contamination-risk
Affected units: 1,195

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 (2)

Lots: L246022 BUD: 6/22/2022
B24208-22 BUD: 8/8/2022

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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