Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY

FDA recall notice · announced February 16, 2022 · Ultratab Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

cGMP Deviations

Notes

Distribution: Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Lot/code information: Product Codes: M693 Bulk Lots: 18J001, 18J002, 18J003, 18L035, 18L036, 18M013, 18M014, 19A044, 19A045, 19B042, 19B043, 19B066, 19C006, 19C007, 19E065, 19E066, 19J045, 19J046
Quantity: 26,682,419 tablets
Status: Terminated
Products in this recall event:
- MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY (F-0729-2022)
- Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY (F-0728-2022)
- Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY (F-0727-2022)
- Caffeine 150 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY (F-0724-2022)
- Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY (F-0721-2022)
- Caffeine 125 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY (F-0723-2022)
- Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY (F-0726-2022)
- Caffeine 175 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY (F-0725-2022)
- Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY (F-0722-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.