Rugby Ferrous Sulfate Elixir Recalled for Yeast and B. cepacia Contamination
Pharmatech LLC is recalling Rugby Ferrous Sulfate Elixir 473 mL due to the presence of yeast and potential contamination with B. cepacia.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving potential contamination with pathogens like B. cepacia are categorized as Severe (Score 4), particularly given the risk of significant injury or hospitalization associated with such contaminants in liquid medications.
Plain-English summary
Pharmatech LLC is voluntarily recalling Rugby Ferrous Sulfate Elixir 473 mL (UPC: 00536-0650-85). The recall was initiated because of the presence of yeast and potential contamination with B. cepacia in the product.
The recall affects all lots remaining within their expiration dates. The product was distributed in Michigan (MI).
Consumers should stop using the recalled product and return it to the place of purchase or contact the manufacturer for instructions on disposal or replacement.
The recalled product
- Product
- Rugby Ferrous Sulfate Elixir 473 mL UPC: 00536-0650-85
- Manufacturer
- Pharmatech LLC
- Category
- Drug — Liquid Medication
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 (1)
- All lots remaining within expiry
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 17 recalled by Pharmatech LLC 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 →Related recalls
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