Drug product
Sodium Bicarbonate and Lidocaine Injection, all strengths and all presentations including Sod-Bicarb-Lido-0.27-2.73-3 syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-405-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 335 vials
- Official record key
drug-enforcement:D-405-2013
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 #: 20130226-GV4, Exp 5/26/2013; 13031150GV3, Exp 6/11/2013; 13031240GV4, Exp 6/12/2013; 13012325GV5, Exp 4/23/2013; 13021820GV3, Exp 5/18/2013; 13011520, Exp 4/15/2013; 13012425GV1, Exp 4/24/2013
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility