FDA recall D-1076-2019

Product

Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA

Reason for recall

Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper

Distribution

California

Key facts

Status

Terminated

Initiation date

2018-08-23

Report date

2019-04-10

Termination date

2023-04-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Stockton, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1076-2019