April 29, 2013
North Wales, PASaratoga Therapeutics, LLC, a distributor, is recalling 900 bottles of ebA Multivitamin Supplement because they may contain undeclared milk protein(s) and lactose, FDA announced last week.
The supplement, whose product label erroneously stated that it was free of milk components, was distributed across the United States and in Australia, Canada, Costa Rica, England, Finland, Ireland, Malaysia, Switzerland, and Tasmania, according to the agency.
The problem came to light after a customer reported an anaphylactic reaction to the supplement, FDA said. Another person reported feeling "sick" while taking ebA. Both individuals were allergic to milk.
A U.S.-based manufacturer of the vitamin tablets is investigating the source of the milk components, noted FDA, which didn't identify the company.
"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," the agency cautioned.
The following lot numbers may be affected: # 0912164 expiration date 12/12; and # 1110354 expiration date 10/14.
Consumers who purchased the supplement may return any unused portion to Saratoga Therapeutics, LLC for a full refund. Contact the company at [email protected] or 215-661-9044 8:30 a.m. to 4:30 p.m. E.T. to request mailing materials and/or for any questions.
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