Drug & medication recalls High risk

STELLALIFE VEGA Oral Care recalled over sterility concerns

Recall date
June 5, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Homeocare Laboratories, Inc. recalls STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street,…
Recall number
D-0609-2024
FDA classification
Class I
Brand / firm
Homeocare Laboratories, Inc.
Sold / distributed
Nationwide to 60 Physician offices

Why it was recalled

Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, 22875 NE 191 Street, Suite 500, Aventura, FL 33180, NDC 69685-121-01

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