Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lots: PL520, PL521, PL522 and PL523
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Fusion Pharmaceuticals, LLC
- Reason for Recall:
- Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML
Product Codes/Lot Numbers:
Lots: PL520, PL521, PL522 and PL523
Distribution:
Distributed in: CA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1055-2014
Related Recalls
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.
Fusion Pharmaceuticals
Class I - Dangerous
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.