FDA Recall D-0864-2017
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 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.
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-0864-2017- 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