D-1051-2014 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 5, 2014
- Initiation Date
- April 15, 2013
- Termination Date
- February 8, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 285 vials
Product Description
HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244
Reason for Recall
Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
Distribution Pattern
Nationwide
Code Information
Lot #s: N06252012@6 Exp 6/25/13; N01042013@15 Exp 1/29/14; N05072012@3 Exp 2/1/15