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.
Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
What was recalled
Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6.
- Recalling firm
- Mylan Pharmaceuticals Inc
- NDC code
- 0378-2512-78
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1217-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Capecitabine recalls
See all
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 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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