D-0410-2015 Class II Terminated
FDA drug recall D-0410-2015 was initiated by Fusion Pharmaceuticals, LLC on March 6, 2015 and is designated Class II. Reason for recall: Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans. The recall status is terminated (terminated October 27, 2015). Affected quantity: 9,439 Kits.
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.