Agency classClass IIOur severity:High FDA (Drugs)·D-0917-2022·Announced 2022-06-01

Alpha Lipoic Acid injection vials recalled for sterility assurance defect

Olympia Compounding Pharmacy is recalling 3,286 vials of Alpha Lipoic Acid 25 mg/mL due to inability to assure sterility. Patients should contact their healthcare provider to verify their medication and discuss alternatives.

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 pharmaceutical product with a confirmed manufacturing defect affecting sterility assurance. This meets the rubric criterion for risk-of-harm products (injectable medication) where injury has not yet been reported; the rule limiting theoretical hazards to Score 3 maximum applies here.

Plain-English summary

Olympia Compounding Pharmacy is recalling 3,286 vials of Alpha Lipoic Acid 25 mg/mL (NDC 73198-0076-30), a prescription injectable medication, because the manufacturer cannot assure the product meets required sterility standards. The vials were distributed nationwide throughout the United States, Puerto Rico, and the U.S. Virgin Islands under lot numbers L24C06, L24B06, and B41023-22.

The recall stems from a manufacturing defect in the compounding process that compromises the assurance of sterility. Although no illnesses or infections have been reported to date, non-sterile injectable medications pose a risk of serious infection to patients.

Patients who have received this medication should contact their healthcare provider to determine whether their dose is from an affected lot. Healthcare providers should review patient records to identify anyone who may have received the recalled vials and should provide affected patients with alternative medication.

The recalled product

Product: Alpha Lipoic Acid 25 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0076-30
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Category: Drug — Injectable Medication
Hazard: sterility-failure
infection-risk
Affected units: 3,286

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: L24C06
L24B06 BUD: 6/6/2022
B41023-22 BUD: 8/23/2022

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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