FDA recall F-0729-2022

ULTRAtab Laboratories, Inc. · Class II · food

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.

Key facts

Status: Terminated
Initiation date: 2021-10-06
Report date: 2022-02-16
Termination date: 2022-09-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Highland, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-0729-2022