D-1531-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 13, 2014
- Initiation Date
- June 25, 2014
- Termination Date
- March 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
G.A.C. 375 Injection USP, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
Reason for Recall
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Distribution Pattern
Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.
Code Information
All lot numbers and exp dates