D-286-2013 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 1, 2013
- Initiation Date
- April 17, 2013
- Termination Date
- April 19, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 vials (5 mL each)
Product Description
17 Alpha Hydroxyprogesterone Caproate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Reason for Recall
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Distribution Pattern
CO, GA, MI, and Puerto Rico
Code Information
ALL Lots