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FDAFDA · Food and drugs·Recall number D-0864-2017

Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated), Calcarea Phosphorica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Magnesia Phosphorica 6X HPUS, Rheum 6X HPUS, Silicea 12X HPUS] Quick-Dissolving Tablets, 135-count bottle, Manufactured for: Hyland's, Inc., Los Angesles, CA 90061, NDC 54973-3197-1, UPC 3 54973 31971 4.

Published May 31, 2017 · Recall initiated: April 13, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.

What to do

Voluntary: Firm initiated · Press Release

Recall details

Manufacturer
Standard Homeopathic Company
Distributor
Nationwide in the USA and Puerto Rico.
Lot
All lots within expiry
Risk classification
Class I
Area (FDA)
drug
Country
United States

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