The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1311-2015·Announced 2015-08-12

Apothecary Shoppe Recalls SIU-Tri-Mix Injectable Due to Sterility Concerns

The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 30/1/20 Injectable in Oklahoma due to a lack of documentation ensuring proper environmental monitoring during production.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a lack of documentation for environmental monitoring, which is a quality control issue rather than a confirmed contamination or reported injury, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

The Apothecary Shoppe LLC, a compounding pharmacy in Tulsa, Oklahoma, is recalling SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vials. The recall involves 113 mL of product distributed in Oklahoma. Specific lots affected include 04102015@38 (Best Use Date: 9/1/2015), 03132015@37 (Best Use Date: 7/11/2015), and 04172015@28 (Best Use Date: 10/14/2015).

The recall was initiated due to a lack of assurance of sterility. The source text states that proper environmental monitoring documentation was missing during the time the medication was produced. This documentation gap raises concerns about the sterility of the injectable product.

Consumers and healthcare providers in Oklahoma who have this product should stop using it and contact The Apothecary Shoppe LLC or their healthcare provider for further instructions. The product is prescription-only and was distributed in Oklahoma.

The recalled product

Product
SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135,NDC 99999-2011-17
Manufacturer
The Apothecary Shoppe LLC
Category
Drug — Compounded Injectable
Hazard

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 (6)

  • Lot #s: 04102015@38
  • BUD: 9/1/2015
  • 03132015@37
  • BUD: 7/11/2015
  • 04172015@28
  • BUD: 10/14/2015

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 28 recalled by The Apothecary Shoppe LLC 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 28 products in this recall →

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