Drug product
Bupivacaine Injection, all strengths and all presentations including a) Bupivacaine Parabens Free 0.5% 50 mL, and b) Bupivacaine PF 0.5% 30 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-352-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 756 vials
- Official record key
drug-enforcement:D-352-2013
Official wording
Reason: Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Code information: Lot #: a) Bupivacaine PF 0.5% 30 mL SDV: 20130318-C, Exp 6/18/2013; 20130319-F, Exp 6/19/2013; b) Bupivacaine Paraben Free 0.5% 50 mL: 20130212-E, Exp 5/12/2013; 20130124-F, Exp 4/24/2013; 20130214-G, Exp 5/14/2013; 20130320-E, Exp 6/20/2013
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility