FDA recall D-1157-2019

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

Product

Heparin 10 mL/ Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/ Normal Saline 5 mL, 60 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-1157-2019