Drug product
Methylprednisolone Acetate and Marcaine Injection, all strengths and all presentations including a) Methylpred 80 mg/mL and Marcaine 0.25%-2.75, b) Methylpred_Marc-0.25-0.27, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
D-388-2013
Product summary
- Event
- Event 64879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 607 vials
- Official record key
drug-enforcement:D-388-2013
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 80 mg/mL and Marcaine 0.25%-2.75: 130312200GV3, Exp 6/12/13; b) Methylpred_Marc-0.25-0.27: 13011536, Exp 4/15/2013; 20130226-GV2, Exp 5/26/2013; 13012335GV4, Exp 4/23/2013; 13012460GV2, Exp 4/24/2013
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility