The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements…
Health risk
The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. A safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.
Action required
Check the identifying codes below and stop using the product. Return it to the retailer for a refund or dispose of it safely, following the recall notice.
Recall closed · classified by the FDANationwide (US)More food
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Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305
United States
Quantity affected
5, 771 units
Recall initiation
FDA report date: September 20, 2017
FDA recall number
F-3515-2017
Beyond the headline
The recall, in context
The Harvard Drug Group initiated this food recall on August 2, 2017. The FDA enforcement report states: 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. The FDA report lists distribution as: Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305.
The FDA enforcement report describes the reason as: 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.
Rugby Calcionate Syrup, One Pint (473 ML) was made or distributed by The Harvard Drug Group in Livonia, MI, United States. This page reflects FDA report F-3515-2017, dated September 20, 2017.
Why this is a Class II recall
Class II means the product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. In this recall, a safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.
FDA definition
The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote.
What to do now
1
Stop using it
Do not eat, drink or take the affected product.
2
Check the codes
Compare the lot and date codes against the table above.
3
Return or discard
Contact the retailer or recalling firm about a refund, and dispose of the product safely.
Consumer safety guide
Product safety recall
Symptoms to watch for
The official enforcement report describes the specific risk. Follow the recall notice, check the product codes and do not use a product that may be affected.
Higher-risk groups
Children, pregnant people, older adults and people with weakened immune systems should take extra care when a product's safety is uncertain.
What to do now
1Stop using or eating the product and keep it away from children and pets.
2Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return.
3Seek medical advice if anyone develops severe or worrying symptoms after exposure.
Read the official source record for the specific hazard and instructions.
This is general consumer safety information, not medical advice or a diagnosis. Follow the official recall notice and contact a healthcare professional if you have concerns about exposure or symptoms.
Frequently asked
Questions about this recall
4 answers
What is the Rugby Calcionate Syrup, One Pint (473 ML) recall?
The Harvard Drug Group recalled Rugby Calcionate Syrup, One Pint (473 ML) in an FDA Class II enforcement action reported as F-3515-2017. The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements…
What should I do if I bought this product?
Check the identifying codes below and stop using the product. Return it to the retailer for a refund or dispose of it safely, following the recall notice. Stop using or eating the product and keep it away from children and pets. Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return. Seek medical advice if anyone develops severe or worrying symptoms after exposure.
Is the The Harvard Drug Group recall still active?
The FDA lists this recall as recall closed. It remains relevant if you still have the affected product or need to identify a historical recall.
Where can I verify this recall?
This page is normalized from the openFDA enforcement record F-3515-2017. You can verify it directly using the official source link on this page. VerifyRecall updates its index from public FDA enforcement data and does not replace advice from the FDA, the recalling firm or a healthcare professional.
Verify before you act.
VerifyRecall is independent and not affiliated with the FDA. Always confirm the latest status on the official source record.