US Drug Recall Register
Class III · Low risk Terminated Initiated Oct 12, 2016 (10 years ago)

HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct

What was recalled

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

Recalling firm
Pharm D Solutions, LLC
Origin
TX, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0427-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.