FDA recall D-0250-2015

Product

Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231.

Reason for recall

Non-Sterility: The firm's contract testing laboratory found sterility failures.

Distribution

Two hospitals in Dallas, TX

Key facts

Status

Terminated

Initiation date

2013-05-31

Report date

2014-11-26

Termination date

2016-08-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dallas, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0250-2015