FDA recall D-0803-2021

Product

MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only, Promise Pharmacy 31818 US Hwy 19N Palm Harbor FL 34684 1-888-3PROMIS

Reason for recall

Lack of processing controls

Distribution

AZ, CO, FL, IL, NJ

Key facts

Status

Terminated

Initiation date

2021-06-30

Report date

2021-09-22

Termination date

2023-06-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Palm Harbor, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0803-2021