Why it was recalled
cGMP Deviations
Product description
Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Lot numbers, UPCs & expiration codes
Product Codes: M975 Bulk Lots: 19E058
Where it was sold
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- F-0726-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 6, 2021
- FDA report date
- Feb 16, 2022
- Quantity
- 955,928 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ULTRAtab Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report F-0726-2022, exactly as published.
Show all FDA fields
- City
- Highland
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 89512
- Address
- 50 Toc Dr
- Code information
- Product Codes: M975 Bulk Lots: 19E058
- Postal code
- 12528-1506
- Report date
- Feb 16, 2022
- Product type
- Food
- Recall number
- F-0726-2022
- Classification
- Class II
- Recalling firm
- ULTRAtab Laboratories, Inc.
- Product quantity
- 955,928 tablets
- Termination date
- Sep 1, 2022
- Reason for recall
- cGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
- Distribution pattern
- Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
- Recall initiation date
- Oct 6, 2021
- Initial firm notification
- Letter
- Center classification date
- Feb 9, 2022