FDA recall D-1144-2019

Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy · Class II · drug

Product

Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.

Reason for recall

Lack of sterility assurance.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2019-04-02
Report date
2019-04-24
Termination date
2021-09-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bristol, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1144-2019