Class II
Terminated
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
- Recall Initiated
- April 9, 2014
- Posted
- July 2, 2014
- Recall Number
- D-1407-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 200 vials
- Firm Location
- Detroit, MI, United States
Reason for Recall
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Distribution
OH
Lot / Code Info
JKM7188A
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