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Class II: temporary or reversible health riskTerminated

Fusion Pharmaceuticals Dicopanol FusePaq Kit for Oral Suspension Recall

Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML

Fusion Pharmaceuticals, LLC · Camarillo, CA

Risk level
Class II
Reported by FDA
Feb 12, 2014
Recall ID
D-1055-2014
Check your lot numberHow we source this data

Summary

Fusion Pharmaceuticals recalled Dicopanol FusePaq Kit for Oral Suspension starting May 8, 2013. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1055-2014 on Feb 12, 2014. Reason: Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits. Status: Terminated.

Why it was recalled

Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.

Product description

Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML

Lot numbers, UPCs & expiration codes

Lots: PL520, PL521, PL522 and PL523

Where it was sold

CA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1055-2014
Classification
Class II
Status
Terminated
Recall initiated
May 8, 2013
FDA report date
Feb 12, 2014
Quantity
1,200 kits
Recall type
Voluntary: Firm initiated
Recalling firm
Fusion Pharmaceuticals, LLC

Original FDA data

Every field from FDA enforcement report D-1055-2014, exactly as published.

Show all FDA fields
City
Camarillo
State
CA
Status
Terminated
Country
United States
Event ID
66139
Address
768 Calle Plano # B
Code information
Lots: PL520, PL521, PL522 and PL523
Postal code
93012-8555
Report date
Feb 12, 2014
Product type
Drugs
Recall number
D-1055-2014
Classification
Class II
Recalling firm
Fusion Pharmaceuticals, LLC
Product quantity
1,200 kits
Termination date
Jan 31, 2014
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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML
Distribution pattern
CA
Recall initiation date
May 8, 2013
Initial firm notification
Letter
Center classification date
Jan 31, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1055-2014, published Feb 12, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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