Why it was recalled
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Product description
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.
Lot numbers, UPCs & expiration codes
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 it was sold
California
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-0410-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 6, 2015
- FDA report date
- Mar 18, 2015
- Quantity
- 9,439 Kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fusion Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0410-2015, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 70682
- Address
- 768 Calle Plano Suite A
- Code information
- 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.
- Postal code
- 93012-8555
- Report date
- Mar 18, 2015
- Product type
- Drugs
- Recall number
- D-0410-2015
- Classification
- Class II
- Recalling firm
- Fusion Pharmaceuticals, LLC
- Product quantity
- 9,439 Kits
- Termination date
- Oct 27, 2015
- Reason for recall
- Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- California
- Recall initiation date
- Mar 6, 2015
- Initial firm notification
- Letter
- Center classification date
- Mar 12, 2015