The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1308-2015·Announced 2015-08-12

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

The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 30/1/10 Injection vials in Oklahoma due to a lack of documentation for 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, which typically involves a reasonable probability of temporary or medically reversible health consequences. The specific issue is a documentation gap regarding environmental monitoring, which is a quality control failure rather than a confirmed contamination event with reported injuries.

Plain-English summary

The Apothecary Shoppe LLC, a compounding pharmacy in Tulsa, Oklahoma, is recalling SIU-Tri-Mix 30/1/10 Injection, a prescription-only medication. The recall involves 10 mL vials with NDC 99999-2196-10. The total quantity affected is 67.5 mL.

The recall was initiated due to a lack of assurance of sterility. Specifically, there was a lack of documentation confirming proper environmental monitoring during the time the medication was produced. The affected lots are 04162015@41 with a beyond-use date of 10/13/2015, and 03122015@42 with a beyond-use date of 7/10/2015.

The product was distributed in Oklahoma. Consumers and healthcare providers should stop using the affected medication and contact their pharmacist or the recalling firm for further instructions.

The recalled product

Product
SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-2196-10
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 (4)

  • Lot #s: 04162015@41
  • BUD: 10/13/2015
  • 03122015@42
  • BUD: 7/10/2015

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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