FDA recall record
Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
FDA classification. FDA Class I, II, and III are not the same as USDA FSIS classifications and are not a cross-agency safety score.
FDA listed a termination date of September 1, 2022. openFDA does not treat this as a live recall-status tracker.
Product described in an FDA recall
Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Reason
cGMP Deviations
Products involved
Product descriptions are copied from the FDA recall record. They are not a current catalog and are not automatically matched to WhoMadeMyFood product pages.
Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Code information listed by FDA
Product Codes: M977A Bulk Lots: 19B011, 19B012, 19E023
Distribution and firm information
Recalling firm listed by FDA: ULTRAtab Laboratories, Inc.
Firm location listed by FDA: Highland, NY, United States
Distribution reported by FDA: Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Product quantity listed by FDA: 1,478,344 tablets
Source
Source: U.S. Food and Drug Administration (FDA), openFDA food enforcement reports.
Official FDA openFDA food enforcement record
Identifying an FDA recall record does not imply FDA endorsement of WhoMadeMyFood. Methodology.