Drug product
L-Lysine Injection, all strengths and all presentations including a) L-Lysine_100-30 mL, b) L-Lysine_100 mg/30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-382-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 132 vials
- Official record key
drug-enforcement:D-382-2013
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) L-Lysine_100-30 mL: 130117300AE, Exp 4/17/2013; 20130118-F, Exp 4/18/2013; 20130129-G, Exp 4/29/2013; 20130131-G, Exp 4/30/2013; b) L-Lysine_100 mg/30 mL: 20130405-E, Exp 7/5/2013
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility