Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Reason for recall: Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. Distribution: Nationwide in the U.S.A. and Belgium/Luxembourg, Brazil, Chile, Colombia, France/French Guiana, Germany, Ireland, Italy/San Marino, Netherlands, Poland, Spain/Andorra, Sweden, Finland, Switzerland/Liechtenstein, United Kingdom of Great Britain and Northern Ireland, Ireland, Denmark, Canada, Hong Kong, Philippines, Israel, Malaysia, Saudi Arabia, Gibraltar. Quantity: 258,750 Vials Lot/code info: Lot 1147308, 1154183, Exp.: 2/28/2025; 1156807, 1160222, Exp.: 6/30/2025; 1160223, 1163912, 1167352, Exp.: 2/28/2026; 1171365, 1175057, 1176250, Exp.: 11/30/2026.
Official record: FDA (Drug enforcement) ↗
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