F-0726-2022 Class II Terminated
FDA food recall F-0726-2022 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: 955,928 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
- 955,928 tablets
Product Description
Melatonin ER 0.5 mg caplet (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: M975 Bulk Lots: 19E058