Standard Homeopathic Company recalls Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X H…

Recall date

April 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0863-2017

FDA classification

Class I

Brand / firm

Standard Homeopathic Company

Sold / distributed

Nationwide in the USA and Puerto Rico.

Why it was recalled

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

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

Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)] Quick-Dissolving Tablets, packaged in a) 40-count bottles (NDC 54973-3127-3) (UPC 3 54973 31273 9); b) 135-count bottles (NDC 54973-3127-1) (UPCs 3 54973 31271 5, 3 54973 31371 2, 3 54973 31481 8); and 250-count bottles (NDC 54973-3127-2) (UPCs 3 54973 31272 2, 3 54973 31521 1), Manufactured for: Hyland's, Inc., Los Angeles, CA 90061.