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Recall Observatory FDA recall evidence

Drug product

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.

D-368-2013

April 10, 2013

Class II

Product summary

Firm
FVS Holdings, Inc. dba. Green Valley Drugs
Event
Event 64879
Status
Terminated
Classification
Class II
Quantity
1140 vials
Official record key
drug-enforcement:D-368-2013

Official wording

Reason: 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.

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility