Bone Builder recalled over manufacturing violations

Recall date

October 9, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sprayology recalls Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096…

Recall number

D-0110-2019

FDA classification

Class II

Brand / firm

Sprayology

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

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

What was recalled

Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0012-1 and Tester NDC 61096-1012-1