Class II · Moderate risk
Gemcitabine Injection
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Gemcitabine For Injection USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
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 For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40
Affected NDC
47335-0154-40
Compare with the code on your package — it is the most precise check available.
Drug: Gemcitabine
- Recalling firm
- Caraco Pharmaceutical Laboratories, Ltd.
- NDC code
- 47335-154-40
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1407-2014 · 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 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
Other recalls by Caraco Pharmaceutical Laboratories, Ltd.
All 2014 recalls
Class II · Moderate risk
Cephalexin Capsules
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
Class II · Moderate risk
Cephalexin Capsules
CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Class III · Low risk
Children's Cetirizine Hydrochloride Chewable Tablets
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
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