Food recall

The Harvard Drug Group recall: Rugby Calcionate Syrup, One Pint (473 mL)

The Harvard Drug Group, of Livonia, MI, recalled Rugby Calcionate Syrup, One Pint (473 mL) and 16 other products. The FDA's reason: “The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to possible...” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on August 2, 2017, and the FDA first listed it in its Enforcement Report of September 20, 2017. 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

See FDA's words below

Status

Terminated

Closed April 28, 2020

The recall

Company
The Harvard Drug Group (Livonia, MI)
Reason, in FDA's words
“The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.”
Where it was sold
Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
78007

The 17 products recalled

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

  • F-3515-2017 Class II

    Rugby Calcionate Syrup, One Pint (473 mL)

    Codes: UPC Number: 0 05362 77085 1, All Unexpired Lots

    Quantity: 5,771 units

  • F-3516-2017 Class II

    Rugby Cerovite Liquid, 8 oz. 236ML

    Codes: Rugby Cerovite Liquid, 236ML, UPC Number: 00536-2790-59, All Unexpired Lots

    Quantity: 65,611 units

  • F-3517-2017 Class II

    Rugby D 3 Vitamin Liquid, 400 IUI/1 mL, 1 and 2/3 oz., 50 mL

    Codes: Rugby D 3 Vitamin Liquid, 400 IUI/1 mL, UPC Number: 0 05368 40080 6, All Unexpired Lots

    Quantity: 105,628 units

  • F-3518-2017 Class II

    Rugby Fer-iron Liquid, 1 and 2/3 oz., 50 mL

    Codes: Rugby Fer-iron Liquid, 1 and 2/3 oz., 50 mL, UPC Number: 00536-0710-80, All Unexpired Lots

    Quantity: 27,011 units

  • F-3519-2017 Class II

    Rugby Liquid Vitamin C Supplement, 4 oz., 118 mL

    Codes: Rugby Liquid Vitamin C Supplement, 4 oz., 118 mL, UPC Number: 0 05360 16097 0, All Unexpired Lots

    Quantity: 30,782 units

  • F-3520-2017 Class II

    Rugby Ferrous Sulfate Liquid One Pint, (473 mL)

    Codes: Rugby Ferrous Sulfate Liquid,One Pint (473 mL), UPC Number:0 05360 65085 8, All Unexpired Lots

    Quantity: 34,280 units

  • F-3521-2017 Class II

    Rugby Polyvitamin Liquid, 1 2/3 oz (50 mL)

    Codes: Rugby Polyvitamin Liquid, 1 2/3 oz (50 mL), UPC Number:0 05368 45080 1, All Unexpired Lots

    Quantity: 113,829 units

  • F-3522-2017 Class II

    Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL)

    Codes: Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL), UPC Number: 0 05368 53080 0, All Unexpired Lots

    Quantity: 117,098 units

  • F-3523-2017 Class II

    Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL)

    Codes: Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL), UPC Number:0 05368 50180 0, All Unexpired Lots

    Quantity: 52,897 units

  • F-3524-2017 Class II

    Major CertaVite Liquid, 8 oz. (236 mL)

    Codes: Major CertaVite Liquid, 8 oz. (236 mL), UPC Number:3 09045 02309 9, All Unexpired Lots

    Quantity: 61,262 units

  • F-3525-2017 Class II

    Major D-Vita Drops, 1 2/3 oz (50 mL)

    Codes: Major D-Vita Drops,1 2/3 oz (50 mL), UPC Number:3 09046 27350 9, All Unexpired Lots

    Quantity: 27,447 units

  • F-3526-2017 Class II

    Major Ferrous Drops, 1 2/3 oz (50 mL)

    Codes: Major Ferrous Drops,1 2/3 oz (50 mL), UPC Number:3 09046 27350 9, All Unexpired Lots

    Quantity: 63,005 units

  • F-3527-2017 Class II

    Major Poly-Vita Drops, 1 2/3 oz (50 mL)

    Codes: Major Poly-Vita Drops,1 2/3 oz (50 mL), UPC Number:3 09045 09950 6, All Unexpired Lots

    Quantity: 27,735 units

  • F-3528-2017 Class II

    Major Poly-Vita Drops with Iron, 1 2/3 oz (50 mL)

    Codes: Major Poly-Vita Drops with Iron,1 2/3 oz (50 mL), UPC Number:3 09045 10050 9, All Unexpired Lots

    Quantity: 33,390 units

  • F-3529-2017 Class II

    Major Tri-Vita Drops, 1 2/3 oz (50 mL)

    Codes: Major Tri-Vita Drops,1 2/3 oz (50 mL), UPC Number: 3 09046 27450 6, All Unexpired Lots

    Quantity: 10,074 units

  • F-3530-2017 Class II

    Leader Liquid Multivitamin Supplement for Infants and Toddlers , 1 2/3 oz (50 mL)

    Codes: Leader Liquid Multivitamin Supplement for Infants and Toddlers 1 2/3 oz (50 mL), UPC Number: 096295128611, All Unexpired Lots

    Quantity: 3,840 units

  • F-3531-2017 Class II

    Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL)

    Codes: Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL), UPC Number: 0 96295 12862 8, All Unexpired Lots

    Quantity: 1,728 units

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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 September 20, 2017.

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.