FDA recall D-0897-2018

Product

Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT

Reason for recall

Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.

Distribution

Product was distributed throughout the United States.

Key facts

Status

Terminated

Initiation date

2018-06-14

Report date

2018-07-11

Termination date

2019-02-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Windsor, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0897-2018