Product Detail

Product Description Edetate Disodium Injection, all strengths and all presentations including
a) Edetate Disodium 150/30 mL
b) Edetate Disodium 150/100 mL
Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Recall Number D-361-2013

Classification Class II

Code Info Lot #:
a) Edetate Disodium_150/30 mL: 20130201-E, Exp 5/2/2013;
b) Edetate Disodium_150/100 mL: 20130124-B, 4/24/2013; 20130213-B, Exp 5/13/2013; 20130213-C, Exp 5/13/2013; 20130401-B, Exp 7/1/2013

Product Distributed Qty 98 vials

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.

Event Detail

Event Id 64879

Product Type Drugs

Status Ongoing

Recalling Firm FVS Holdings, Inc. dba. Green Valley Drugs, Henderson, NV, USA

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-04-10

Initial Firm Notification of Consignee or Public Press Release

Distribution Pattern Nationwide