Class II · Moderate risk Terminated
Domperidone 10 mg capsules
Reason Lack of Processing Controls.
Domperidone BP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.
What 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.
- Recalling firm
- Freedom Pharmaceuticals Inc
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0567-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Domperidone recalls
See all
Class I · High risk Terminated
Domperidone capsules 10 mg
Reason Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
Class II · Moderate risk Terminated
Domperidone active pharmaceutical ingredient packaged in varying…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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