Rhondium OVC3 One Visit Crown recalled over sterility concerns

Recall date

January 31, 2019

Source

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

Official notice title

RHONDIUM LIMITED recalls Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondiu…

Recall number

Z-0708-2020

FDA classification

Class II

Brand / firm

RHONDIUM LIMITED

Sold / distributed

Distribution was made to IL, NM, TX, and WI. There was no foreign/military/government distribution.

Why it was recalled

The product was mislabeled with an incorrect expiration date.

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

What was recalled

Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand.