Medical device recalls Moderate risk

Sheffield Pharmaceuticals, LLC recalls Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.

Recall date
April 27, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1953-2015
FDA classification
Class II
Brand / firm
Sheffield Pharmaceuticals, LLC
Sold / distributed
Worldwide Distribution -- CA, NJ, FL, PR, NJ, MI, NY, NC, FL, IL, GA, MN, KS, and NC; and, the countries of Jamaica and Georgia.

Why it was recalled

Recovery of high count of gram positive rods including single colonies of B. cepacia.

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

What was recalled

Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.

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