drugs Class II Updated 2015-03-18

Fusion Pharmaceuticals, LLC recalls DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral sus

Recalled Product

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.

Hazard / Issue

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

Issued by

FDA

Distribution: California
Lot/Code Info: 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.
View official government recall

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