Home / ULTRAtab Laboratories, Inc. / F-0727-2022
Class II
ULTRAtab Laboratories, Inc.
Recall #F-0727-2022 · Initiated 2021-10-06
Product
Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Reason for recall
cGMP Deviations
Quantity affected
5,853,539 tablets
Distribution
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Lot / code info
Product Codes: M976 Bulk Lots: 19B050, 19F063
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Letter
Terminated
2022-09-01
Recalling firm
ULTRAtab Laboratories, Inc.
50 Toc Dr
Highland, NY 12528-1506
United States
Recall classification
Remote probability of serious adverse health consequences, or temporary reversible consequences.
Other recalls from ULTRAtab Laboratories, Inc.
Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY
MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY
Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Caffeine 150 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY