Recalls / Class II

Class IID-357-2013

Product

Dexamethasone Sodium Phosphate Injection, all strengths and all presentations including a) Dexamethasone Sodium Phosphate 10 mg/1 mL, b) Dexamethasone Sodium Phosphate 10 mg/mL PF 1 mL, c) Dexamethasone Sodium Phosphate 4 mg/30 mL, d) Dexamethasone-4 mg/5 mL P.F., Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Affected lot / code info

Lot #: a) Dexamethasone Sodium Phosphate 10mg/1ml: 20130402-F, Exp 7/2/2013; b) Dexamethasone Sodium Phosphate 10mg/ml PF 1ml: 20130307-H, Exp 6/7/2013; c) Dexamethasone Sodium Phosphate 4mg/30ml: 20130117-B, Exp 4/17/2013; 20130326-C, Exp 6/26/2013; 20130307-E, Exp 6/7/2013; 20130221-D, Exp 5/21/2013; d) Dexamethasone-4mg/5ml P.F.: 20130328-L, Exp 6/28/2013

Why it was recalled

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.

Recalling firm

Firm

FVS Holdings, Inc. dba. Green Valley Drugs

Notification channel

Press Release

Type

Voluntary: Firm initiated

Address

1850 Whitney Mesa Dr, Suite 180, Henderson, Nevada 89014-2091

Distribution

Quantity

4399 vials

Distribution pattern

Nationwide

Timeline

Recall initiated

2013-04-10

FDA classified

2013-05-16

Posted by FDA

2013-05-22

Terminated

2014-03-21

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-357-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.