Class II · Moderate risk
Tri-Mix 18/1/10
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
SIU-Tri-Mix 30/1/10 Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-2196-10
- Recalling firm
- The Apothecary Shoppe LLC
- NDC code
- 99999-2196-10
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1308-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by The Apothecary Shoppe LLC
All 2015 recalls
Class II · Moderate risk
Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Class II · Moderate risk
Methylcobalamin 5000 mcg/mL Injection
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Class II · Moderate risk
S-Methylcobalamin 5000 mcg/mL Inj.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Other sterility / contamination recalls from 2015
All sterility / contamination recalls
Class I · High risk
Human Chorionic Gonadotropin
Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
Class II · Moderate risk
Baclofen
Lack of assurance of sterility
Class II · Moderate risk
IT Custom Compound
Lack of Assurance of Sterility
Class II · Moderate risk
Baclofen 1 mg/ml in 40 ml NS syringe
Lack of Assurance of Sterility
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