Drug product
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
D-1407-2014
Product summary
- Event
- Event 68209
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 vials
- Official record key
drug-enforcement:D-1407-2014
Official wording
Reason: Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Code information: JKM7188A
Distribution pattern: OH
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility