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Hyland's Teething Tablets (October 26, 2010)

Report a Concern
Starting date:
October 26, 2010
Posting date:
November 22, 2010
Type of communication:
Drug Recall
Subcategory:
Natural health products
Hazard classification:
Unacceptable risk to health
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-2010A250

Reason

The recall was initiated in both Canada and US as a precautionary measure after the company and the U.S. Food and Drug Administration (FDA) conducted a review of the company's adverse event reports and manufacturing processes in regards to its Hyland's Teething Tablets product. They have identified manufacturing processes that can be improved to ensure uniformity in dosage of the Belladonna 3X ingredient. According to U.S. FDA testing, Hyland's Teething Tablets may pose a risk to children.

Depth of distribution

Distributors, natural health products stores and pharmacies in Canada.

Affected products

Hyland's Teething Tablets

DIN, NPN, DIN-HIM

Homeopathic Product with the DIN 01956485 indicated on the label

Dosage form

Tablets

Strength

  • Belladonna 3X HPUS
  • Calcarea phosphorica 3X HPUS
  • Chamomilla 3X HPUS
  • Coffea cruda 3X HPUS

Lot or serial number

All lots

Companies

Recalling Firm
Hyland's Homeopathic Canada Inc.
381 Route 139N
Sutton Quebec
Canada J0E 2K0
Marketing Authorization Holder
Hyland's Homeopathic Canada Inc.
381 Hwy. 139N
Sutton Quebec
Canada J0E 2K0