Class II · Moderate risk
Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and…
Lack of Processing Controls.
Capecitabine Tablets
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.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
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.
Affected NDC
0378-2512-78
Compare with the code on your package — it is the most precise check available.
Drug: Capecitabine
- 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 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Capecitabine recalls
See all
Class II · Moderate risk
Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Capecitabine tablets USP 500 mg
Failed Dissolution Specifications: low test results at the 18 month time-point
Class II · Moderate risk
Capecitabine active pharmaceutical ingredient packaged in varying…
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.
Other recalls by Mylan Pharmaceuticals Inc
All 2015 recalls
Class II · Moderate risk
Carton label: Mycophenolate Mofetil for injection
Failed Dissolution Specifications
Class II · Moderate risk
Prasugrel Tablets
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Class II · Moderate risk
Acamprosate Calcium
Failed Dissolution Specifications
Class II · Moderate risk
Mycophenolate Mofetil for Injection USP
Presence of precipitate
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