Fusion Pharmaceuticals Recalls Contaminated Diphenhydramine Oral Suspension Kits
Fusion Pharmaceuticals is recalling 9,439 kits of Dicopanil oral suspension due to microbial contamination with Burkholderia multivorans. The affected kits were distributed in California.
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 recall is classified as FDA Class II and involves microbial contamination with Burkholderia multivorans, which poses a significant health risk, meeting the criteria for a Severe rating.
Plain-English summary
Fusion Pharmaceuticals, LLC is recalling 9,439 kits of Dicopanil (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. The product is identified by NDC 43093-104-01. The recall involves specific lot numbers: PL713 through PL722 and PL735 through PL744, all with an expiry date of 7/20/2015.
The recall was initiated because the kit component is contaminated with Burkholderia multivorans, a type of microbial contamination. The agency has classified this as a Class II recall. The affected product was distributed in California.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement. Since this is a prescription-only product, patients should consult their prescriber regarding alternative treatments.
The recalled product
- Product
- DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion Pharmaceuticals LLC., 768 Calle Plano, Camarillo, CA 93012. NDC: 43093-104-01.
- Manufacturer
- Fusion Pharmaceuticals, LLC
- Category
- Drug — Oral Suspension
- Affected units
- 9,439
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 (20)
- Lot Numbers: PL713
- PL714
- PL715
- PL716
- PL717
- PL718
- PL719
- PL720
- PL721
- PL722
- PL735
- PL736
- PL737
- PL738
- PL739
- PL740
- PL741
- PL742
- PL743
- PL744
Distribution
Distributed in 1 state:
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