Class II · Moderate risk
Gemcitabine Injection
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Gemcitabine Injection 200mg/5.26ml
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL
Affected NDC
72485-0221-02
Compare with the code on your package — it is the most precise check available.
Drug: Gemcitabine
- Recalling firm
- Cardinal Health Inc.
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0432-2021 · 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 Gemcitabine recalls
See all
Class II · Moderate risk
Gemcitabine
Lack of Assurance of Sterility
Class II · Moderate risk
Gemcitabine 1910 MG / 250 ML NS IVPB
Lack of Assurance of Sterility
Class I · High risk
Gemcitabine for Injection
Presence of Particulate Matter
Class I · High risk
Gemcitabine for Injection
Presence of Particulate Matter
Other recalls by Cardinal Health Inc.
All 2021 recalls
Class II · Moderate risk
Enoxaparin Sodium Injection
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Class II · Moderate risk
Recombinate
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
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