FDA recall D-0141-2024

Wells Pharma of Houston LLC · Class II · drug

Product

ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Pharma, NDC 73702-131-10

Reason for recall

Lack of assurance of sterility.

Distribution

Philadelphia, Pennsylvania.

Key facts

Status: Completed
Initiation date: 2023-11-22
Report date: 2023-12-13
Voluntary/Mandated: Voluntary: Firm initiated
Location: Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0141-2024