Agency classClass IIOur severity:High FDA (Drugs)·D-0931-2022·Announced 2022-06-01

Lidocaine-Epinephrine Injectable Vials Recalled for Sterility Assurance Failure

Olympia Compounding Pharmacy is recalling Lidocaine 1%/Epinephrine 1:100,000 injection vials due to lack of sterility assurance. The recall affects 310 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 a sterile injectable pharmaceutical with no reported illnesses or injuries. The lack of sterility assurance in multi-dose injection vials represents a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Olympia Compounding Pharmacy is recalling Lidocaine 1%/Epinephrine 1:100,000/mL Multi-Dose 30 mL vials (NDC 73198-0099-30) due to lack of assurance of sterility. The recall includes 310 vials with lot K41023 and beyond-use date of 5/23/2022, distributed nationwide across the USA, Puerto Rico, and US Virgin Islands.

This injectable medication is used for local anesthesia with vasoconstriction in medical and dental procedures. A failure to ensure sterility in multi-dose vials poses a potential contamination risk to patients receiving injections from affected vials.

Healthcare providers and patients who possess vials from this lot should cease use immediately and contact Olympia Compounding Pharmacy or their healthcare provider for guidance on safe disposal and alternative products. No illnesses or injuries have been reported as of the recall announcement.

The recalled product

Product: Lidocaine 1%/Epinephrine 1:100,000/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0099-30
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Category: Drug — Injectable / Local Anesthetic
Hazard: sterility-failure
Affected units: 310

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: K41023 BUD: 5/23/2022

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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