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Recall Observatory FDA recall evidence

Food product

Rugby Calcionate Syrup, One Pint (473 mL)

F-3515-2017

August 02, 2017

Class II

Product summary

Firm
The Harvard Drug Group
Event
Event 78007
Status
Terminated
Classification
Class II
Quantity
5,771 units
Official record key
food-enforcement:F-3515-2017

Official wording

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.

Code information: UPC Number: 0 05362 77085 1, All Unexpired Lots

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.

Field note

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