Drug Enforcement D-393-2013

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.

Status

Terminated

Classification

Class II

Report Date

May 22, 2013

Termination Date

March 21, 2014

Product Information

Product description
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.
Product quantity
4350 vials and syringes
Reason for recall
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.
Recall initiation reason
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Initial firm notification
Press Release
Distribution pattern
Nationwide

Location & Firm

Recalling firm
FVS Holdings, Inc. dba. Green Valley Drugs
Address
1850 Whitney Mesa Dr, Suite 180

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-393-2013
Event ID
64879
Recall initiation date
April 10, 2013
Center classification date
May 16, 2013
Code info
a) Methylprednisolone Acetate 40 mg/mL: 20130228-E, Exp 5/28/2013; 2013012370-GV3, Exp 4/23/2013; 20130318-D, Exp 6/18/2013; b) Methylprednisolone Acetate (PF) 40 mg/mL: 20130219-B, Exp 5/19/2013; 20130315-B, Exp 6/15/2013; c) Methylprednisolone Acetate (PF) 80 mg/mL: 201303131-A, Exp 6/13/2013; 20130304-M, Exp 6/4/2013; 20130405-A, Exp 7/5/2013; 20130214-G, Exp 5/14/2013; d) Methylpred Acetate 40 mg/mL 1 mL: 20130318-D, Exp 6/18/2013; e) Methylprednisolone 80 mg/5 mL: 20130214-G, Exp 5/14/2013
More code info
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