CLASS II Drug recall · Reported 12 Aug 2015 · FDA Enforcement Report
SIU-Tri-Mix 30/1/20 Injectable recalled by The Apothecary Shoppe
The Apothecary Shoppe is recalling SIU-Tri-Mix 30/1/20 Injectable, distributed in Oklahoma. The recall was initiated on 26 Jun 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1311-2015
- FDA event ID
- 71618
- Recalling firm
- The Apothecary Shoppe, Tulsa, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jun 2015
- FDA classified
- 6 Aug 2015
- Reported
- 12 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Jun 2015 | Recall initiated by company | |
| 6 Aug 2015 | Classified by FDA | +41 days |
| 12 Aug 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
SIU-Tri-Mix 30/1/20 Injectable, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135,NDC 99999-2011-17
Where it was distributed
Oklahoma
Questions about this recall
Is SIU-Tri-Mix 30/1/20 Injectable recalled?
Yes. The Apothecary Shoppe recalled SIU-Tri-Mix 30/1/20 Injectable on 26 Jun 2015. The recall is Class II and its status is Terminated. Recall number D-1311-2015.
Why was it recalled?
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Which lots are affected?
Lot #s: 04102015@38, BUD: 9/1/2015; 03132015@37, BUD: 7/11/2015; 04172015@28, BUD: 10/14/2015
Where was it sold?
Oklahoma
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.