Drug & medication recalls Moderate risk

Earache Drops recalled over sterility concerns

Recall date
May 24, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Grato Holdings, Inc. recalls Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-…
Recall number
D-0991-2022
FDA classification
Class II
Brand / firm
Grato Holdings, Inc.
Sold / distributed
Nationwide within the USA

Why it was recalled

Microbial contamination of non-sterile product.

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

What was recalled

Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15

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