Drug product
BET-ACE-LIDO-6-2 Injection, all strengths and all presentations including 7 mL syringe and Betameth Combo 6 mg/mL Lidocaine 2% Syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-347-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 435 vials and syringes
- Official record key
drug-enforcement:D-347-2013
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 #: 13012320-GV1, Exp 4/23/2013; 13021840GV1, Exp 5/18/2013; 13031150GV1, Exp 6/11/2013; 13021840GV1, Exp 5/18/2013; 13012320-GV1, Exp 4/23/2013; 13011532, Exp 4/15/2013.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility