FDA recall D-1076-2020

Product

C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 63323-0010-02.

Reason for recall

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Distribution

Specific prescriptions to patients in TN

Key facts

Status

Terminated

Initiation date

2020-03-13

Report date

2020-04-08

Termination date

2022-10-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cleveland, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1076-2020