CLASS II Drug recall · Reported 12 Feb 2014 · FDA Enforcement Report
Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML recalled
Fusion Pharmaceuticals is recalling Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML, distributed in California. The recall was initiated on 8 May 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1055-2014
- FDA event ID
- 66139
- Recalling firm
- Fusion Pharmaceuticals, Camarillo, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 May 2013
- FDA classified
- 31 Jan 2014
- Reported
- 12 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
Timeline
| 8 May 2013 | Recall initiated by company | |
| 31 Jan 2014 | Classified by FDA | +268 days |
| 12 Feb 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML
Where it was distributed
CA
Questions about this recall
Why was it 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.
Which lots are affected?
Lots: PL520, PL521, PL522 and PL523
Where was it sold?
CA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fusion Pharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dicopanol (diphenhydramine hydrochloride recalled | Fusion Pharmaceuticals | Sterility | CA |