D-0016-2014 Class II Terminated
FDA drug recall D-0016-2014 was initiated by Avella of Deer Valley, Inc. on October 1, 2014 and is designated Class II. Reason for recall: Crystallization: Formation of crystals observed in product. The recall status is terminated (terminated February 20, 2015). Affected quantity: 197 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- October 22, 2014
- Initiation Date
- October 1, 2014
- Termination Date
- February 20, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 197 vials
Product Description
HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.
Reason for Recall
Crystallization: Formation of crystals observed in product.
Distribution Pattern
Nationwide
Code Information
Lot# 12-20140207@109; Exp. 12/14 Lot# 12-20142107@82; Exp. 01/15