Terminated Class II

ULTRAtab Laboratories, Inc.

Recall F-0729-2022 · Highland, NY

Product

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

Reason for recall

cGMP Deviations

Distribution

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

Quantity affected

42,352,387 tablets

Recall type

Voluntary: Firm initiated

Lot / code info

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

Timeline

6 Oct 2021 initiated → 9 Feb 2022 classified → 16 Feb 2022 reported → 1 Sep 2022 terminated

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