Agency classClass IIOur severity:High FDA (Drugs)·D-1242-2022·Announced 2022-07-20

Vitamin D3 50,000IU Compounded Product Recalled for Sterility Assurance Failure

Tailor Made Compounding has recalled Vitamin D3 50,000IU/mL vials nationwide due to lack of sterility assurance during manufacturing. No illnesses have been reported.

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 compounded pharmaceutical due to sterility assurance failure. No illnesses or injuries have been reported. While potential contamination poses health risk, the hazard remains theoretical without confirmed harm.

Plain-English summary

Tailor Made Compounding is recalling Vitamin D3 50,000IU/mL compounded product due to lack of assurance of sterility. The affected batch (02252201A1, expiration 4/15/2022) consists of 15 vials distributed nationwide in the United States and Puerto Rico.

The recall was issued because insufficient controls were in place to ensure the sterility of the product during manufacturing. No illnesses or injuries associated with this product have been reported to date.

Patients who have this product should not use any remaining vials. Contact your healthcare provider for guidance on proper disposal and to discuss continued vitamin D supplementation.

The recalled product

Product: Vitamin D3 50,000IU/mL, 10mL-vial, Room Temperature, Tailor Made Compounding
Manufacturer: TMC Acquisition LLC dba Tailor Made Compounding
Category: Drug — Compounded pharmaceutical
Hazard: sterility-failure
contamination
Affected units: 15

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)

Batch#: 02252201A1
Exp 4/15/2022.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 52 recalled by TMC Acquisition LLC dba Tailor Made Compounding 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 52 products in this recall →

Same manufacturer · TMC Acquisition LLC dba Tailor Made Compounding

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Same hazard · sterility failure