Drug & medication recalls Moderate risk

Promise Pharmacy, LLC recalls Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 m…

Recall date
December 17, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0438-2019
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

Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2 mg/2.5 mg/25 mg/ 25 mg/ 2 mg/ 25 mg/mL 10 mL vial, Rx Only, Compounded Prescription, Promise Pharmacy Compounding Specialists, 31818 US Hwy 19N, Palm Harbor FL 34684

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