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
Recall initiated: 20140128
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated