FDA recall D-0990-2016

Product

HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Reason for recall

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Distribution

NV

Key facts

Status

Terminated

Initiation date

2016-05-17

Report date

2016-06-15

Termination date

2017-01-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Las Vegas, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0990-2016