Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gemcitabine For Injection USP Recalled by Caraco Pharmaceutical Laboratories, Ltd. Due to Lack of Assurance of Sterility: A particle excursion...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Caraco Pharmaceutical Laboratories, Ltd. directly.
Affected Products
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
Quantity: 200 vials
Why Was This 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.
Where Was This Sold?
This product was distributed to 1 state: OH
About Caraco Pharmaceutical Laboratories, Ltd.
Caraco Pharmaceutical Laboratories, Ltd. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report