FDAFDA · Food and drugs·Recall number F-0727-2022
Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Published February 16, 2022 · Recall initiated: October 6, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Distributor
- Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
- Lot
- Product Codes: M976 Bulk Lots: 19B050, 19F063
- Risk classification
- Class II
- Area (FDA)
- food
- Country
- United States
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