Home / Recalls / Standard Homeopathic Company / D-0863-2017

D-0863-2017 Class I Terminated

Recalled by Standard Homeopathic Company — Los Angeles, CA

Recall Details

Product Type: Drugs
Report Date: May 31, 2017
Initiation Date: April 13, 2017
Termination Date: October 26, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10,263,585 bottles

Product Description

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA and Puerto Rico.

Code Information

All lots within expiry