October 2014 FDA Recall Drug by Avella Of Deer Valley, Inc.
D-0016-2014 - Crystallization

This Class II drug recall was voluntarily initiated by Avella Of Deer Valley, Inc. on October 1, 2014 for the product Drug. The FDA reported the reason for recall as crystallization. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0016-2014

Reason for Recall
Crystallization: Formation of crystals observed in product.
Initiated
10-01-2014
Reported
10-22-2014
Quantity
197 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69405
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.
Avella of Deer Valley, Inc.
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-20-2015
Product Description About Product Description
Full technical description of the product.
HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.

Batch or Lot Expiration Information

Lot# 12-20140207@109; Exp. 12/14
Lot# 12-20142107@82; Exp. 01/15