FDAFDA · Alimentos y medicamentos·N.º oficial D-1250-2015
Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Publicado el 29 de julio de 2015 · Inicio del retiro: 22 de abril de 2015
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
CGMP Deviations: Firm did not adequately investigate customer complaints.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Wockhardt Usa Inc.
- Distribuidor
- U.S. Nationwide including Puerto Rico.
- Lote
- A) Lot #: LM10806, Expiry: 5/31/2015; Lot #: LM11099, Expiry: 6/30/2015; Lot #: LM11297, Expiry: 7/31/2015; Lot #: LM11933, Expiry: 10/31/2015; Lot #: LN10180, Expiry: 12/31/2015; Lot #: LN10547, Expiry: 2/29/2016. B) Lot #: LM10784, Expiry: 5/31/2015; Lot #: LM10791, Expiry: 5/31/2015; Lot #: LM10812, Expiry: 5/31/2015; Lot #: LM11112, Expiry: 6/30/2015; Lot #: LM11298, Expiry: 7/31/2015; Lot #: LM11299, Expiry: 7/31/2015; Lot #: LM11625, Expiry: 8/31/2015; Lot #: LN10182, Expiry: 12/31/2015; Lot #: LN10548, Expiry: 2/29/2016; Lot #: LN11115, Expiry: 5/31/2016; Lot #: LN11367, Expiry: 8/31/2016; Lot #: LN11369, Expiry: 8/31/2016. C) Lot #: LM10813, Expiry: 5/31/2015; Lot #: LM11085, Expiry: 6/30/2015; Lot #: LM11088, Expiry: 6/30/2015; Lot #: LM11296, Expiry: 7/31/2015; Lot #: LM11932, Expiry: 10/31/2015; Lot #: LN10181, Expiry: 12/31/2015; Lot #: LN10549, Expiry: 2/29/2016; Lot #: LN11114, Expiry: 5/31/2016; Lot #: LN11359, Expiry: 8/31/2016.
- Clasificación de riesgo
- Class II
- Área (FDA)
- drug
- País
- United States
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