FDA recall F-0727-2022

Product

Melatonin ER 2 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.

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-0727-2022