PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: January 20, 2016 Initiated: March 10, 2015 #D-0567-2016

Product Description

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.

Details

Units Affected
20 kg
Distribution
Nationwide
Location
Broken Arrow, OK

Frequently Asked Questions

What product was recalled?
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.. Recalled by Freedom Pharmaceuticals Inc. Units affected: 20 kg.
Why was this product recalled?
Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 20, 2016. Severity: Moderate. Recall number: D-0567-2016.