FDAClass IIJanuary 20, 2016

Domperidone BP recall: Contamination

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.

Why was Domperidone BP recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: F10349, F10349A, F10349B, F10349C, F10349D, F10349E, Exp 01/15; F10829, F10829A, F10829B, F10829C, F10829-2, F10829-2A, F10829-2B, F10829-2D, F10829-2E, F10829-3, F10829-3A, F10829-3B, F10829-3C, F10829-3D, Exp 01/17; F11035, F11035A, F11035B, F11035C, Exp 08/17

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.
Recalling firm
Freedom Pharmaceuticals Inc
Quantity
20 kg
Distribution
Nationwide
Recall date
January 20, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls