FDA Drug recall D-368-2013
Gentamicin Injection, all strengths and all presentations including a) Gentamicin 40 mg/2 mL, b) Gentamicin 40 mg/30 mL, c) Gentamicin-40-2…
- FDA Drug
- Class II
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class II recall of Gentamicin Injection, all strengths and all presentations including a) Gentamicin 40 mg/2 mL, b) Gentamicin 40 mg/30 mL, c) Gentamicin-40-2… by Fvs Holdings Dba Green Valley Drugs, citing lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associate….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-368-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-10 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fvs Holdings Dba Green Valley Drugs |
| Distribution | US |
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.
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.
Identifiers
| 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: 201302…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-368-2013%22
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