Class IIFDA6 Oct 2021F-0721-2022

ULTRAtab Laboratories, Inc. recalls Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, (Class II)

Class II — Eating this product may cause temporary or medically reversible health problems; serious harm is unlikely.

Product

Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY; Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY; Caffeine 125 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY; Caffeine 150 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY; Caffeine 175 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY; Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY; Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY; Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY; MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY

Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY
Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY
Caffeine 125 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Caffeine 150 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Caffeine 175 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY

Reason for recall

cGMP Deviations

Affected products (9)

Recall #	Product	Lot / code	Status
F-0721-2022	Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY	Product Codes: M943 M943L Bulk Lots: 16K038, 18B075	Terminated
F-0722-2022	Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY	Product Codes: M693 Bulk Lots: 18J001, 18J002, 18J003, 18L035, 18L036, 18M013, 18M014, 19A044, 19A045, 19B042, 19B043, 19B066, 19C006, 19C007, 19E065, 19E066, 19J045, 19J046	Terminated
F-0723-2022	Caffeine 125 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY	Product Codes: M960L Bulk Lots: 19E021, 19E022	Terminated
F-0724-2022	Caffeine 150 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY	Product Codes: M961L Bulk Lots: 19E030, 19E031	Terminated
F-0725-2022	Caffeine 175 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY	Product Codes: M962L Bulk Lots: 19E032, 19E033	Terminated
F-0726-2022	Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY	Product Codes: M975 Bulk Lots: 19E058	Terminated
F-0727-2022	Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY	Product Codes: M976 Bulk Lots: 19B050, 19F063	Terminated
F-0728-2022	Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY	Product Codes: M977A Bulk Lots: 19B011, 19B012, 19E023	Terminated
F-0729-2022	MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY	Product Codes: M978 Bulk Lots: 18J069, 18J070, 18J071, 18M072, 18L124, 18L125, 18L126, 19C037, 19C038, 19C039, 19C040,19D029, 19D030, 19D031, 19G047, 19G048, 19G049, 19G050	Terminated

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