Drug & medication recalls Moderate risk

SIU-Tri-Mix 18/1/20 Injection recalled over sterility concerns

Recall date
June 26, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
The Apothecary Shoppe LLC recalls SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-…
Recall number
D-1303-2015
FDA classification
Class II
Brand / firm
The Apothecary Shoppe LLC
Sold / distributed
Oklahoma

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1563-48

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