Drug 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.
D-0864-2017
Product summary
- Event
- Event 77009
- Status
- Terminated
- Classification
- Class I
- Quantity
- 692,115 bottles
- Official record key
drug-enforcement:D-0864-2017
Official wording
Reason: Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
Code information: All lots within expiry
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Superpotent