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FDA recall record

LOISIM Dietary Supplement (unknown container size)

Recall F-1035-2017Class IITerminatedOctober 13, 2015

FDA classification. FDA Class I, II, and III are not the same as USDA FSIS classifications and are not a cross-agency safety score.

FDA listed a termination date of April 10, 2017. openFDA does not treat this as a live recall-status tracker.

Product described in an FDA recall

LOISIM Dietary Supplement (unknown container size)

Reason

Pursuant to a consent decree that prohibits the company and its owners for marketing dietary supplements until they, among other things, recall and destroy the dietary supplements that have been manufactured or distributed since April 2, 2014, hire a cGMP expert and receive written permission from FDA to resume operations.

Products involved

Product descriptions are copied from the FDA recall record. They are not a current catalog and are not automatically matched to WhoMadeMyFood product pages.

  • LOISIM Dietary Supplement (unknown container size)

Code information listed by FDA

As persuant to the Consent Decree, the firm agreed to "recall and destroy, under FDA's supervision, in accordance with the procedures provided in paragraph 6, ALL dietary supplements that were manufactured, prepared, processed, packed, labeled, held and/or distributed between April 2, 2014 and the date of entry of this Decree." The Decree was entered on September 25, 2015. Known lot: Lot # 111114

Distribution and firm information

Recalling firm listed by FDA: Sunset Natural Products Inc.

Firm location listed by FDA: Miami, FL, United States

Distribution reported by FDA: Products distributed to Florida, Nevada and the Dominican Republic

Product quantity listed by FDA: Unknown

Source

Source: U.S. Food and Drug Administration (FDA), openFDA food enforcement reports.

Official FDA openFDA food enforcement record

Identifying an FDA recall record does not imply FDA endorsement of WhoMadeMyFood. Methodology.