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Eba Multivitamin Supplement By Saratoga Therapeutics LLC: Recall - Allergy Alert On Undeclared Milk Components
AUDIENCE: Consumer, Patient, Health Professional
ISSUE: Saratoga Therapeutics, LLC of North Wales, PA recalled 900 bottles of ebA Multivitamin Supplement because they may contain undeclared milk components – milk protein(s) and lactose. The label lists the product as being free of milk components. People with an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction and people who have lactose intolerance run the risk of gastrointestinal symptoms if they consume ebA Multivitamin Supplement.
Affected lot numbers include #0912164 expiration date 12/12 and #1110354 expiration date 10/14.
BACKGROUND: ebA Multivitamin Supplement was distributed nationwide and in Australia, Canada, Costa Rica, England, Finland, Ireland, Malaysia, Switzerland, and Tasmania. and reached consumers by mail order, fax order, internet sales and doctors' office sales. The vitamins are packaged in a white plastic bottle with white, green and blue labeling. The expiration date is listed beneath the Warning section on the label.
RECOMMENDATION: Consumers who have purchased ebA Multivitamin Supplement may return any unused portion of the product to Saratoga Therapeutics, LLC for a refund. Contact the company at info@xxxxxxxxxxxxxxxxxxx or 215-661-9044 8:30 a.m. to 4:30 p.m. east coast time to request mailing materials and/or for any questions.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Press Release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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