Rugby Ferrous Sulfate Liquid Recalled for B. cepacia Contamination
The Harvard Drug Group is voluntarily recalling Rugby Ferrous Sulfate 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 Ferrous Sulfate Liquid One Pint (473 mL). The recall involves 34,280 units of the product, which was distributed nationwide in the United States and to specific VA facilities.
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 check their inventory for Rugby Ferrous Sulfate Liquid One Pint (473 mL) with UPC Number 0 05360 65085 8. All unexpired lots are affected. Patients should consult their healthcare provider if they have concerns regarding the use of this product.
The recalled product
- Product
- Rugby Ferrous Sulfate Liquid One Pint, (473 mL)
- Manufacturer
- The Harvard Drug Group
- Category
- Drug — Liquid Supplement
- Affected units
- 34,280
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 (4)
- Rugby Ferrous Sulfate Liquid
- One Pint (473 mL)
- UPC Number:0 05360 65085 8
- 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.
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