Terminated Class II

ULTRAtab Laboratories, Inc.

Recall F-0726-2022 · Highland, NY

Product

Melatonin ER 0.5 mg caplet (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

955,928 tablets

Recall type

Voluntary: Firm initiated

Lot / code info

Product Codes: M975 Bulk Lots: 19E058

Timeline

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

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