17-016 QA PRODUCT RECALL – HYLANDS TEETHING TABS BY ...

17-016 QA PRODUCT RECALL ? HYLANDS TEETHING TABS BY HYLANDS INC DUE TO MISLABELING

Date: 14 APR 2017

Recall: # 17-016

Scope: WORLDWIDE RETAIL STORES

In consultation with the US Food & Drug Administration (FDA), Standard Homeopathic Company is recalling all lots of Hyland's Baby Teething Tablets. The FDA has concluded that the medicines have been found to contain inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the products' labels.

Hazard: The FDA believes that belladonna represents a serious health hazard to children and that the effects of belladonna are unpredictable.

Incidents/Injuries: The company is initiating the voluntary recall out of an abundance of caution.

Description: The items below are involved in this recall.

Remedy: Consumers with questions may contact Standard Homeopathic Comapny at 1-800-991-3376

Sold at: Nationwide retail stores.

Manufacturer(s): Standard Homeopathic Company

Quality Assurance Management

Merchandise Directorate

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