FDA recall D-1524-2014

Product

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

Nationwide and Foriegn distribution was made to Canada, United Kingdom, Australia, Slovenia, Germany, Spain, Finland and Croatia.

Key facts

Status

Terminated

Initiation date

2014-06-25

Report date

2014-08-13

Termination date

2017-03-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Clive, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1524-2014