Freedom Pharmaceuticals Recalls Domperidone API Due to Penicillin Cross-Contamination

Plain-English summary

Freedom Pharmaceuticals Inc is recalling 20 kg of Domperidone BP, an active pharmaceutical ingredient intended for prescription compounding. The product is packaged in 5 gm, 25 gm, 100 gm, and 500 gm containers and is distributed nationwide. The recall is being conducted because the products have the potential to be cross-contaminated with penicillin.

The affected lots include F10349 series (Exp 01/15), F10829 series (Exp 01/17), and F11035 series (Exp 08/17). The source text does not specify the number of units affected beyond the total weight of 20 kg, nor does it report any specific illnesses or injuries associated with this recall.

Healthcare providers and compounding pharmacies should stop using the affected lots of Domperidone API and contact Freedom Pharmaceuticals for further instructions. Consumers should not use this product, as it is an active pharmaceutical ingredient for prescription compounding and not a finished consumer medication.

The recalled product

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.

Manufacturer

Freedom Pharmaceuticals Inc

Category

Drug — Active Pharmaceutical Ingredient

Hazard

• allergen-penicillin
• cross-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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