Multi-event April 2017 FDA Recall Drug by Standard Homeopathic Company

This Multi-event Class I drug recall was voluntarily initiated by Standard Homeopathic Company on April 13, 2017 for the product Drug. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0864-2017 TERMINATED D-0863-2017 TERMINATED

Recall Number: D-0864-2017

Reason for Recall
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
Initiated
04-13-2017
Reported
05-31-2017
Quantity
692,115 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77009
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Standard Homeopathic Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-26-2017
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# All lots within expiry

Recall Number: D-0863-2017

Reason for Recall
Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.
Initiated
04-13-2017
Reported
05-31-2017
Quantity
10,263,585 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77009
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Standard Homeopathic Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-26-2017
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# All lots within expiry