FDA recall D-0427-2017

Pharm D Solutions, LLC · Class III · drug

Product

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

Reason for recall

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

Distribution

AZ and WA

Key facts

Status
Terminated
Initiation date
2016-10-12
Report date
2017-01-18
Termination date
2017-05-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0427-2017