Drug & medication recalls Moderate risk

Promise Pharmacy, LLC recalls ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg/2.5mg/25…

Recall date
December 17, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0466-2019
FDA classification
Class II
Brand / firm
Promise Pharmacy, LLC
Sold / distributed
Nationwide in the USA.

Why it was recalled

Lack of sterility assurance.

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

What was recalled

ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg/2.5mg/25mg/5mg/5mg/0.1mg/1.5mg/25mg/25mg/10mg/ML, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

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