FDA recall D-1164-2014

Product

Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION USE ONLY***RX South LLC DBA RX3 12230 Iron Bridge Rd Chester, VA 23831***

Reason for recall

Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping

Distribution

Product was distributed in Virginia and Maryland.

Key facts

Status

Terminated

Initiation date

2014-01-28

Report date

2014-03-26

Termination date

2014-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chester, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1164-2014