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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Food

The Harvard Drug Group: 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.

Agency Publication Date: September 12, 2017
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Affected Products

Product: Rugby Calcionate Syrup, One Pint (473 mL)

UPC Number: 0 05362 77085 1, All Unexpired Lots

Product: Rugby Cerovite Liquid, 8 oz. 236ML

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

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

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

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

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

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

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

Product: Rugby Ferrous Sulfate Liquid One Pint, (473 mL)

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

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

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

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

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

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

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

Product: Major CertaVite Liquid, 8 oz. (236 mL)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78007
Status: Resolved
Manufacturer: The Harvard Drug Group
Manufactured In: United States
Units Affected: 17 products (5,771 units; 65,611 units; 105,628 units; 27,011 units; 30,782 units; 34,280 units; 113,829 units; 117,098 units; 52,897 units; 61,262 units; 27,447 units; 63,005 units; 27,735 units; 33,390 units; 10,074 units; 3,840 units; 1,728 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.