Drug & medication recalls Moderate risk

Ear Pain MD Pain Relief Drops For Kids bottles recalled over manufacturing violations

Recall date
August 4, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Eosera, Inc. recalls Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 Sout…
Recall number
D-1498-2020
FDA classification
Class II
Brand / firm
Eosera, Inc.
Sold / distributed
Nationwide within the United States

Why it was recalled

cGMP Deviations.

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

What was recalled

Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0070-8

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