Class II · Moderate risk Terminated
Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply
Reason Lack of Processing Controls.
Is Capecitabine recalled?
5 FDA recalls mention Capecitabine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Capecitabine.
Class II · Moderate risk Terminated
Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech…
Reason Failed Dissolution Specifications: low test results at the 18 month time-point
Class II · Moderate risk Terminated
Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78…
Reason Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
Class II · Moderate risk Terminated
Capecitabine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front…
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…
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