The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1309-2015·Announced 2015-08-12

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

The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 30/2/20 Injection in Oklahoma due to a lack of documentation proving 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for serious injury or hospitalization (implied by sterility failure in injectable drugs) fall under the Severe category.

Plain-English summary

The Apothecary Shoppe LLC, a compounding pharmacy in Tulsa, Oklahoma, is recalling SIU-Tri-Mix 30/2/20 Injection, a prescription-only medication packaged in 10 mL vials. The recall affects 75 mL of the product distributed in Oklahoma. Specific lots involved include 04082015@45, 04162015@28, and 03182015@9.

The recall was initiated due to a lack of assurance of sterility. The source text indicates that proper environmental monitoring during the time the medication was produced was not documented. This documentation gap raises concerns about the sterility of the product.

Consumers and healthcare providers in Oklahoma who have this specific medication should stop using it and contact their healthcare provider or the pharmacy for further instructions. The FDA has classified this recall as Class II.

The recalled product

Product
SIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1398-47
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: 04082015@45
  • BUD 9/1/2015
  • 04162015@28
  • BUD 10/13/2015
  • 03182015@9
  • BUD 7/16/2015

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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