The Recall Desk
SevereFDA (Food)·F-3518-2017·Announced 2017-09-20

Rugby Fer-iron Liquid Recalled for B. cepacia Contamination

The Harvard Drug Group is voluntarily recalling Rugby Fer-iron Liquid due to possible contamination with B. cepacia, which may cause serious infections in vulnerable patients.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the source text explicitly states the contamination may result in serious infections that could be life-threatening, meeting the criteria for a Severe rating.

Plain-English summary

The Harvard Drug Group, along with distribution firms Leader Brand and Major Pharmaceuticals, is voluntarily recalling Rugby Fer-iron Liquid, 1 and 2/3 oz., 50 mL. The recall involves 27,011 units of the product, which was distributed nationwide in the United States and to the VA CMOP Charleston facility. All unexpired lots with UPC Number 00536-0710-80 are affected.

The recall is being initiated due to possible product contamination with B. cepacia. This bacterium 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.

Consumers should stop using the recalled product and contact the recalling firm for further instructions or a refund.

The recalled product

Product
Rugby Fer-iron Liquid, 1 and 2/3 oz., 50 mL
Affected units
27,011

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by The Harvard Drug Group under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →