Agency classClass IIOur severity:High FDA (Drugs)·D-0915-2022·Announced 2022-06-01

Vitamin D3 Injectable Recalled Due to Sterility Assurance Issues

Olympia Compounding Pharmacy is recalling Vitamin D3 injectable vials due to lack of sterility assurance. A total of 3,083 vials were 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 for an injectable pharmaceutical product with unassured sterility. While no illnesses or injuries have been reported, failure to meet sterility standards in an injectable product poses significant risk of infection and serious adverse health consequences if contaminated product is administered.

Plain-English summary

Olympia Compounding Pharmacy is recalling Vitamin D3 (50,000 IU/mL) Multi-Dose 30 mL injectable vials. The affected product is supplied as a prescription-only medication with NDC 73198-0075-30, manufactured by Olympia Compounding Pharmacy located at 6700 Conroy Road, Suite 155, Orlando, Florida 32835.

The recall was issued because the manufacturer cannot assure that the product meets sterility standards. Injectable pharmaceutical products must be sterile to prevent patient infection and serious health complications.

A total of 3,083 vials were distributed nationwide, including to Puerto Rico and the US Virgin Islands. The affected lot numbers are L24009 (with a beyond-use date of June 9, 2022) and L24028 (with a beyond-use date of June 28, 2022). Healthcare providers and patients who have received this product should stop use immediately and consult with their healthcare provider about alternative treatment options.

The recalled product

Product: Vitamin D3 (50,000 IU/mL)Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0075-30
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Category: Drug — Compounded Injectable
Hazard: sterility-assurance
contamination-risk
Affected units: 3,083

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: L24009 BUD: 6/9/2022
L24028 BUD: 6/28/2022

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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