D-0863-2017 Class I Terminated
FDA drug recall D-0863-2017 was initiated by Standard Homeopathic Company on April 13, 2017 and is designated Class I. Reason for recall: Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels. The recall status is terminated (terminated October 26, 2017). Affected quantity: 10,263,585 bottles.
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