FDA-Food2022-02-16Class II

Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY

ULTRAtab Laboratories, Inc.
Hazard

cGMP Deviations

Sold states
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Affected count
5,853,539 tablets
Manufactured in
50 Toc Dr, N/A, Highland, NY, United States
Products
Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-0727-2022

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