FDAFDA · Food and drugs·Recall number D-1407-2014
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
Published July 2, 2014 · Recall initiated: April 9, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Caraco Pharmaceutical Laboratories, Ltd.
- Distributor
- OH
- Lot
- JKM7188A
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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