Class II · Moderate risk
Product label: Temozolomide Capsules
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Temozolomide 20 mg NDC 43975-0253-05 28 days supply
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
Temozolomide 20 mg NDC 43975-0253-05 28 days supply
Affected NDC
43975-0253-05
Compare with the code on your package — it is the most precise check available.
Drug: Temozolomide
- Recalling firm
- Kroger Specialty Pharmacy, Inc.
- NDC code
- 43975-0253-05
- Origin
- MS, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0780-2018 · 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 Temozolomide recalls
See all
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
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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