The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1302-2015·Announced 2015-08-12

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

The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 17/0.6/5.7 Injectable in Oklahoma due to lack of assurance of sterility from missing environmental monitoring documentation.

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, and the hazard is a documentation issue regarding environmental monitoring rather than a confirmed contamination or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 17/0.6/5.7 Injectable, a prescription-only 5 mL vial, in Oklahoma. The recall is due to a lack of assurance of sterility resulting from the lack of documentation of proper environmental monitoring during the time the medication was produced.

The affected product is identified by Lot # 04162015@36 with a beyond-use date of 10/13/2015. The product was distributed in Oklahoma.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
SIU-Tri-Mix 17/0.6/5.7 Injectable, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2348-22
Manufacturer
The Apothecary Shoppe LLC
Category
Drug — 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 (2)

  • Lot #: 04162015@36
  • BUD 10/13/2015

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 →

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