Food recall

ULTRAtab Laboratories, Inc. recall: Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY

ULTRAtab Laboratories, Inc., of Highland, NY, recalled Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY and 8 other products. The FDA's reason: “cGMP Deviations.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on October 6, 2021, and the FDA first listed it in its Enforcement Report of February 16, 2022. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

Labeling, packaging or manufacturing problems

Status

Terminated

Closed September 1, 2022

The recall

Company
ULTRAtab Laboratories, Inc. (Highland, NY)
Reason, in FDA's words
“cGMP Deviations”
Where it was sold
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
89512

The 9 products recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-0721-2022 Class II

    Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY

    Codes: Product Codes: M943 M943L Bulk Lots: 16K038, 18B075

    Quantity: 4,250,842 tablets

  • F-0722-2022 Class II

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

    Codes: 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

  • F-0723-2022 Class II

    Caffeine 125 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY

    Codes: Product Codes: M960L Bulk Lots: 19E021, 19E022

    Quantity: 1,904,760 tablets

  • F-0724-2022 Class II

    Caffeine 150 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY

    Codes: Product Codes: M961L Bulk Lots: 19E030, 19E031

    Quantity: 1,606,966 tablets

  • F-0725-2022 Class II

    Caffeine 175 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY

    Codes: Product Codes: M962L Bulk Lots: 19E032, 19E033

    Quantity: 1,393,353 tablets

  • F-0726-2022 Class II

    Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY

    Codes: Product Codes: M975 Bulk Lots: 19E058

    Quantity: 955,928 tablets

  • F-0727-2022 Class II

    Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY

    Codes: Product Codes: M976 Bulk Lots: 19B050, 19F063

    Quantity: 5,853,539 tablets

  • F-0728-2022 Class II

    Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY

    Codes: Product Codes: M977A Bulk Lots: 19B011, 19B012, 19E023

    Quantity: 1,478,344 tablets

  • F-0729-2022 Class II

    MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY

    Codes: Product Codes: M978 Bulk Lots: 18J069, 18J070, 18J071, 18M072, 18L124, 18L125, 18L126, 19C037, 19C038, 19C039, 19C040,19D029, 19D030, 19D031, 19G047, 19G048, 19G049, 19G050

    Quantity: 42,352,387 tablets

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of February 16, 2022.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.