Class II · Moderate risk Terminated
Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and…
Reason Lack of Processing Controls.
Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Processing Controls.
What was recalled
Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply
- Recalling firm
- Kroger Specialty Pharmacy, Inc.
- NDC code
- 00378-2511-91
- Origin
- MS, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0790-2018
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 tablets USP 500 mg
Reason Failed Dissolution Specifications: low test results at the 18 month time-point
Class II · Moderate risk Terminated
Capecitabine Tablets
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…
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 were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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