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FDAFDA · Food and drugs·Recall number D-1164-2014

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***

Published March 26, 2014 · Recall initiated: January 28, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
RX South LLC DBA RX3 Pharmacy
Distributor
Product was distributed in Virginia and Maryland.
Lot
Lot number: 12052013:03 Expiration date: 06/03/2014
Risk classification
Class II
Area (FDA)
drug
Country
United States

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