Drug product
Methylprednisolone, Lidocaine, and Sodium Chloride Injection, all strengths and all presentations including a) Methylpred-Lido-Nacl-1-5-6-12 syringe and b) Methylpred80mg/lido1%/Sodium Chloride0.9% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-391-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 720 syringes
- Official record key
drug-enforcement:D-391-2013
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) Methylpred-Lido-Nacl-1-5-6-12 syringe: 20120226-GV3, Exp 5/26/2013; 13012370GV3, Exp 4/23/2013; 13012480, Exp 4/24/2013; 13011550, Exp 4/15/2013; b) Methylpred80mg/lido1%/Sodium Chloride0.9% syr: 13012370-GV3, Exp 4/23/2013
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility