FDA Drug Class II — Moderate

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***

Hazard

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

Products

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/1
Brand
RX South LLC DBA RX3 Pharmacy
UPC
Lot number: 12052013:03 Expiration date: 06/03/2014

Units Affected

250 syringes