Class II · Moderate risk
Gemcitabine Injection
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Gemcitabine
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1566-50
Affected NDC
5446-1566-50
Compare with the code on your package — it is the most precise check available.
Drug: Gemcitabine
- Recalling firm
- Edge Pharma, LLC
- NDC code
- 05446-1566-50
- Origin
- VT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0403-2022 · 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 Injection 200mg/5.26ml
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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 Edge Pharma, LLC
All 2021 recalls
Class II · Moderate risk
Trypan Blue 0.03%
CGMP Deviations
Class II · Moderate risk
Vancomycin HCl Oral Solution
CGMP Deviations
Class II · Moderate risk
Tetracaine HCl Nasal Solution
CGMP Deviations
Class II · Moderate risk
Promethazine HCl Topical Ointment
CGMP Deviations
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