Home / Recalls / Fusion Pharmaceuticals, LLC / D-0410-2015

D-0410-2015 Class II Terminated

Recalled by Fusion Pharmaceuticals, LLC — Camarillo, CA

Recall Details

Product Type: Drugs
Report Date: March 18, 2015
Initiation Date: March 6, 2015
Termination Date: October 27, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9,439 Kits

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.

Reason for Recall

Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.

Distribution Pattern

California

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.