FDA recalls · F-0726-2022
ULTRAtab Laboratories, Inc. recall
- FoodMelatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
- ReasoncGMP Deviations
- ClassClass II: the food could cause temporary or treatable health problems
- StatusClosed by FDA, ended 2022-09-01
- DatesFirm started it 2021-10-06. In FDA's enforcement report 2022-02-16.
- Sold inBulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
- Amount955,928 tablets
- CodesProduct Codes: M975 Bulk Lots: 19E058
- FirmULTRAtab Laboratories, Inc., Highland, NY · Voluntary: Firm initiated
Products we list
None. We tie a recall to a product only by a barcode printed in the recall, and this one names none we list. That does not mean the recalled food is missing from our listings.
From FDA's enforcement report, via openFDA (CC0): raw data for this recall. FDA's own Enforcement Report search finds it by its number, F-0726-2022. Class meanings: FDA.