Class IITerminated in FDA datasetRecall initiated Aug 2, 2017

Rugby Calcionate Syrup, One Pint (473 mL)

Recalling firm: The Harvard Drug Group

Why it was recalled

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…

Historical recall record. This is not a new recall announcement. “Terminated” describes the FDA recall process; it does not certify that an individual package is safe. FDA termination date: Apr 28, 2020.

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ProductRugby Calcionate Syrup, One Pint (473 mL)
Package size473 mL
UPC005362770851

FDA code information

UPC Number: 0 05362 77085 1, All Unexpired Lots

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Full FDA record and distribution details

Original product description

Rugby Calcionate Syrup, One Pint (473 mL)

Extracted codes and context

TypeCode / valueContext
UPC005362770851UPC Number: 0 05362 77085 1, All Unexpired Lots

Original FDA recall 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 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.

Recall details

Recall number
F-3515-2017
Event ID
78007
FDA status
Terminated
Initiated
Aug 2, 2017
Reported
Sep 20, 2017
Classified
Sep 12, 2017
Terminated
Apr 28, 2020
Quantity
5,771 units
Location
Livonia, MI, United States
Initiation type
Voluntary: Firm initiated
Notification
Press Release

Where it was distributed

Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305

FDA source record · F-3515-2017

Data updated September 16, 2026. View official FDA data ↗

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