Reported Mar 18, 2015 · Terminated
DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion…
Fusion Pharmaceuticals, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fusion Pharmaceuticals, LLC · 768 Calle Plano Suite A · Camarillo, CA · 93012-8555
Is this the product you have?
- 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
- NDC43093-104-01
- Lot codes and dates
- Lot Numbers
PL713PL714PL715PL716PL717PL718PL719PL720PL721PL722PL735PL736PL737PL738PL739PL740PL741PL742PL743PL744
- Expiry7/20/2015
- Lot Numbers
- Amount recalled
- 9,439 Kits
Where it was sold
Why it was recalled
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
This product could cause temporary or reversible health problems — stop using it.
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