Drug 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.
D-0410-2015
Product summary
- Event
- Event 70682
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,439 Kits
- Official record key
drug-enforcement:D-0410-2015
Official wording
Reason: Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
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.
Distribution pattern: California
Derived failure modes
-
Microbial contamination
Microbial Contamination