CLASS II Drug recall · Reported 18 Mar 2015 · FDA Enforcement Report
Dicopanol (diphenhydramine hydrochloride recalled
Fusion Pharmaceuticals is recalling Dicopanol (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq Kits, distributed in California. The recall was initiated on 6 Mar 2015 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-0410-2015
- FDA event ID
- 70682
- Recalling firm
- Fusion Pharmaceuticals, Camarillo, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Mar 2015
- FDA classified
- 12 Mar 2015
- Reported
- 18 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Allergy Medication
Timeline
| 6 Mar 2015 | Recall initiated by company | |
| 12 Mar 2015 | Classified by FDA | +6 days |
| 18 Mar 2015 | Published in enforcement report | +6 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 a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
California
Questions about this recall
Why was it recalled?
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Which lots are affected?
Lot Numbers: PL713, PL714, PL715, PL716, PL717, PL718, PL719, PL720, PL721, PL722, PL735, PL736, PL737, PL738, PL739, PL740, PL741, PL742, PL743, PL744; Expiry: 7/20/2015.
Where was it sold?
California
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 FusePaq Kit for Oral Suspension, 5mg/ML recalled | Fusion Pharmaceuticals | Mold | CA |