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FDA recall record

MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY

Recall F-0729-2022Class IITerminatedOctober 6, 2021

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 September 1, 2022. openFDA does not treat this as a live recall-status tracker.

Product described in an FDA recall

MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY

Reason

cGMP Deviations

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.

  • MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY

Code information listed by FDA

Product Codes: M978 Bulk Lots: 18J069, 18J070, 18J071, 18M072, 18L124, 18L125, 18L126, 19C037, 19C038, 19C039, 19C040,19D029, 19D030, 19D031, 19G047, 19G048, 19G049, 19G050

Distribution and firm information

Recalling firm listed by FDA: ULTRAtab Laboratories, Inc.

Firm location listed by FDA: Highland, NY, United States

Distribution reported by FDA: Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.

Product quantity listed by FDA: 42,352,387 tablets

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.