Product Detail

Product Description Gentamicin Injection, all strengths and all presentations including
a) Gentamicin 40 mg/2 mL,
b) Gentamicin 40 mg/30 mL,
c) Gentamicin-40-20 mL,
d) Gentamicin-40 mg/mL-2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Recall Number D-368-2013

Classification Class II

Code Info Lot #
a) Gentamicin 40 mg/2 mL: 20130403-D, Exp 7/3/2013; 20130227-H, Exp 5/27/2013;
b) Gentamicin 40 mg/30 mL: 20130204-E, Exp 5/4/2013;
c) Gentamicin-40-20 mL: 20130204-E, Exp 5/4/2013;
d) Gentamicin-40 mg/mL-2 mL; 20130227-A, Exp 5/27/2013

Product Distributed Qty 1140 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