FDA-Drug2013-05-22Class II
Methylprednisolone Acetate Injection, all strengths and all presentations including a) Methylprednisolone Acetate 40 mg/mL, b) Methylprednisolone Acetate (PF) 40 mg/mL, c) Methylprednisolone Acetate (PF) 80 mg/mL, d) Methylpred Acetate 40 mg/mL 1 mL, e) Methylprednisolone 80 mg/5 mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
FVS Holdings, Inc. dba. Green Valley Drugs
Hazard
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.
Sold states
Nationwide
Affected count
4350 vials and syringes
Manufactured in
1850 Whitney Mesa Dr, Suite 180, Henderson, NV, United States
Products
Methylprednisolone Acetate Injection, all strengths and all presentations including a) Methylprednisolone Acetate 40 mg/mL, b) Methylprednisolone Acetate (PF) 40 mg/mL, c) Methylprednisolone Acetate (PF) 80 mg/mL, d) Methylpred Acetate 40 mg/mL 1 mL, e) Methylprednisolone 80 mg/5 mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-393-2013Don't want to check this manually?
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