HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1723-20
Recall Number: D-0427-2017
Firm: Pharm D Solutions, LLC
Classification: Class III
Status: Terminated
Report Date: 20170118
Initiation Date: 20161012
Termination Date: 20170511
Reason for Recall
Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct
Product Description
HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1723-20