The Recall Desk
ModerateFDA (Drugs)·D-1304-2015·Announced 2015-08-12

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

The Apothecary Shoppe is recalling SIU-Tri-Mix Injection Solution because proper environmental monitoring documentation was missing during production.

What this means for you

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 and involves a documentation issue regarding sterility assurance without reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 6/0.33/3.33 Injection Solution, a prescription-only medication available in 3 mL vials. The recall is limited to Lot # 03192015@27, which has a beyond-use date of July 13, 2015. The product was distributed in Oklahoma.

The recall was initiated due to a lack of assurance of sterility. The firm identified that proper environmental monitoring documentation was missing during the time the medication was produced. This documentation gap prevents verification that the product met sterility standards.

Consumers and healthcare providers in Oklahoma who possess this specific lot of SIU-Tri-Mix Injection Solution should stop using it and contact their pharmacist or The Apothecary Shoppe LLC for further instructions.

The recalled product

Product
SIU-Tri-Mix 6/0.33/3.33 Injection Solution, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2007-70

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)

  • Lot #: 03192015@27
  • BUD 07/13/2015

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 →