FDA recall D-0527-2016

Product

Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35 mL syringe, c) 440 units/0.44 mL, d) 500 units/0.5 mL syringe, e) Heparin 800 units/0.8 f) Heparin 2300 units/2.3 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Reason for recall

Lack of Assurance of Sterility

Distribution

Texas

Key facts

Status

Terminated

Initiation date

2015-11-10

Report date

2016-01-06

Termination date

2017-10-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Antonio, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0527-2016