January 2014 FDA Recall Drug by Rx South Llc Dba Rx3 Pharmacy
D-1164-2014 - Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping

This Class II drug recall was voluntarily initiated by Rx South Llc Dba Rx3 Pharmacy on January 28, 2014 for the product Drug. The FDA reported the reason for recall as crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping. The product was distributed in Product was distributed in Virginia and Maryland. and the recall is currently terminated.

Recall Number: D-1164-2014

Reason for Recall
Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
Initiated
01-28-2014
Reported
03-26-2014
Quantity
250 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67432
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
RX South LLC DBA RX3 Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed in Virginia and Maryland.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-10-2014
Product Description About Product Description
Full technical description of the 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***

Batch or Lot Expiration Information

Lot# Lot number: 12052013:03 Expiration date: 06/03/2014