FDA recall D-0567-2016

Product

Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (NDC: 52372-0898-04), Cas No. 57808-66-9, Rx only, FREEDOM, 801 W. New Orleans St., Broken Arrow, OK 74011.

Reason for recall

Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-03-10

Report date

2016-01-20

Termination date

2016-06-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Broken Arrow, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0567-2016