Class II · Moderate risk
Capecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply
Lack of Processing Controls.
Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Processing Controls.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply
Affected NDC
0378-2512-78
Compare with the code on your package — it is the most precise check available.
Drug: Capecitabine
- Recalling firm
- Kroger Specialty Pharmacy, Inc.
- NDC code
- 00378-2512-78
- Origin
- MS, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0791-2018 · 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 tablets USP 500 mg
Failed Dissolution Specifications: low test results at the 18 month time-point
Class II · Moderate risk
Capecitabine Tablets
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability 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 Kroger Specialty Pharmacy, Inc.
All 2018 recalls
Class II · Moderate risk
Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply
Lack of Processing Controls.
Class II · Moderate risk
Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply
Lack of Processing Controls.
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