FDA Recall D-0863-2017

Standard Homeopathic Company · Los Angeles, CA

Class I — life-threatening Terminated 196 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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.

Lot / code: All lots within expiry

Quantity: 10,263,585 bottles

Reason for recall

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

Recall record

Recall number: D-0863-2017
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide in the USA and Puerto Rico.
Recall initiated: 2017-04-13
Classified by FDA Center: 2017-05-24
FDA published: 2017-05-31
Terminated: 2017-10-26
Recalling firm: Standard Homeopathic Company
Firm location: Los Angeles, CA

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