F-0729-2022 Class II Terminated
FDA food recall F-0729-2022 was initiated by ULTRAtab Laboratories, Inc. on October 6, 2021 and is designated Class II. Reason for recall: cGMP Deviations The recall status is terminated (terminated September 1, 2022). Affected quantity: 42,352,387 tablets.
Recall Details
- Product Type
- Food
- Report Date
- February 16, 2022
- Initiation Date
- October 6, 2021
- Termination Date
- September 1, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42,352,387 tablets
Product Description
MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY
Reason for Recall
cGMP Deviations
Distribution Pattern
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Code Information
Product Codes: M978 Bulk Lots: 18J069, 18J070, 18J071, 18M072, 18L124, 18L125, 18L126, 19C037, 19C038, 19C039, 19C040,19D029, 19D030, 19D031, 19G047, 19G048, 19G049, 19G050