D-1524-2014 Class II Terminated

Recalled by Medical Supply Liquidators Llc — Clive, IA

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

Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial, 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