Fusion Pharmaceuticals Recalls Dicopanol FusePaq Kits Due to Yeast Contamination
Fusion Pharmaceuticals is recalling Dicopanol FusePaq Kits for Oral Suspension because they contain yeast and mold levels above USP limits.
The agency’s classification
FDA (Drugs): 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 with potential for adverse health consequences are classified as Severe (Score 4).
Plain-English summary
Fusion Pharmaceuticals, LLC is recalling 1,200 kits of Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML. The recall affects lots PL520, PL521, PL522, and PL523, which were distributed in California.
The recall was initiated because the product was found to have Total Yeasts and Molds Counts above the limits established by the United States Pharmacopeia (USP). This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have these specific lots of Dicopanol FusePaq Kits should stop using them and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML
- Manufacturer
- Fusion Pharmaceuticals, LLC
- Category
- Drug — Oral Suspension
- Affected units
- 1,200
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 (3)
- Lots: PL520
- PL521
- PL522 and PL523
Distribution
Distributed in 1 state:
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