FDA (Drugs) recall action 64879

FVS Holdings, Inc. dba. Green Valley Drugs recalled 78 products on 2013-05-22

The FDA (Drugs) publishes a recall like this one as 78 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 78 pages.

Products: 78
Announced: 2013-05-22
Critical: 0
Units: 75,292

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

26–50 of 78

SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Hydrochloric Acid Injection Due to Sterility Concerns
Green Valley Drugs is recalling Hydrochloric Acid Injection products because of a lack of assurance of sterility and quality control concerns.
Product
Hydrochloric Acid Injection, all strengths and all presentations including a) Hydrochloric Acid 0.6%, b) Hydrochloric Acid 2%, c) Hydrochloric Acid Injection 0.06% 30 mL, d) Hydrochloric Acid 2 mg/mL Injection 30 mL vial, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Hend
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Medroxyprogesterone Acetate Injection for Sterility Concerns
Green Valley Drugs is recalling Medroxyprogesterone Acetate Injection due to a lack of assurance of sterility in its compounding and quality control processes.
Product
Medroxyprogesterone Acetate Injection, all strengths and all presentations including a) Medroxyprogesterone 150-30 mL, b) Medroxyprogesterone Acetate 150 mg/mL in 1 mL, 10 mL, 30 mL vials, c) Medroxyprogesterone Acetate 150 mg/mL PF syringe, d) Medroxyprogesterone Acetate 150 mg/
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Bacteriostatic Water for Injection Due to Sterility Concerns
Green Valley Drugs is recalling Bacteriostatic Water for Injection because the company cannot ensure the products are sterile.
Product
Bacteriostatic Water for Injection, all presentations including 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Lipotropic Injections Due to Sterility Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling 209 vials of Lipotropic With Vitamin Injections nationwide due to a lack of assurance of sterility.
Product
Lipotropic With Vitamin Injections, all strengths and all presentations including a) Lipo W/ Vitamin 100 mL, b) Lipo W/ Vitamins 30 mL, c) Lipo W/Vitamin, d) Lipo w/Vitamins #5 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Gentamicin Injection Due to Sterility Concerns
Green Valley Drugs is recalling 1,140 vials of Gentamicin Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.
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.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Dexpanthenol Injection Due to Sterility Concerns
Green Valley Drugs is recalling 273 vials of Dexpanthenol Injection nationwide due to a lack of assurance of sterility and quality control concerns.
Product
Dexpanthenol Injection, all strengths and all presentations including Dexpanthenol 250 mg/30 mL; Dexpanthenol 250 mg/mL 10 mL, 30 mL, 50 mL; and Dexpanthenol 250 mg/mL 10 mL P.F.; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Glycerin/Lidocaine/Epinephrine Injection Due to Sterility Concerns
Green Valley Drugs is recalling Glycerin/Lidocaine/Epinephrine Injection because the pharmacy could not ensure the sterility of the compounded products.
Product
Glycerin/Lidocaine/Epinephrine Injection including Glycerin 72% Lido:Epi 2-1-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Methylprednisolone and Marcaine Injections for Sterility Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling 607 vials of Methylprednisolone Acetate and Marcaine Injection due to lack of assurance of sterility and quality control concerns.
Product
Methylprednisolone Acetate and Marcaine Injection, all strengths and all presentations including a) Methylpred 80 mg/mL and Marcaine 0.25%-2.75, b) Methylpred_Marc-0.25-0.27, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Lidocaine Injections Due to Sterility Concerns
Green Valley Drugs is recalling Lidocaine Injection products because the pharmacy could not ensure the sterility of the compounded and repackaged items.
Product
Lidocaine Injection, all strengths and all presentations including a) Lidocaine _HCl-0.5%, b) Lidocaine HCl, c) Lidocaine 1%, d) Lidocaine 1% 50 mL, e) Lidocaine 2 %, f) Lidocaine 2% 50 mL, g) Lidocaine 2% 50 mL MDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Vitamin D3 Injections Due to Sterility Concerns
Green Valley Drugs is recalling Vitamin D3 injections because the pharmacy could not ensure the products were sterile. The recall covers 18 vials distributed nationwide.
Product
Vitamin D3 Injection, all strengths and all presentations including a) Cholecalciferol D3 50,000iu 30 mL, b) Calcitriol D3 10,000iu, and c) Calcitriol D3 50,000iu, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Zinc Sulfate Injection Due to Sterility Concerns
Green Valley Drugs is recalling 208 vials of Zinc Sulfate Injection because the pharmacy could not ensure the products were sterile.
Product
Zinc Sulfate Injection, all strengths and all presentations including a) Zinc Sulfate 10 mg/mL 30 mL and b) Zinc Sulfate 1 mg/mL 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Lipotropic Injection Due to Sterility Concerns
Green Valley Drugs is recalling Lipotropic With Vitamins, Carnitine, Chromium and Glutamine Injection because the pharmacy could not ensure the products were sterile.
Product
Lipotropic With Vitamins, Carnitine, Chromium and Glutamine Injection, all strengths and all presentations including Lipo W/Vitamin-Carn-Crom_Glut-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Cyclosporine Injection Due to Sterility Concerns
Green Valley Drugs is recalling Cyclosporine Injection products due to a lack of assurance of sterility and quality control concerns.
Product
Cyclosporine Injection, all strengths and all presentations including Cyclosporine 2% Aqueous Solution 15 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
FDA Recalls L-Glutathione Injection Due to Sterility Assurance Concerns
Green Valley Drugs is recalling L-Glutathione Injection vials because the FDA identified a lack of sterility assurance and quality control concerns.
Product
L-Glutathione Injection, all strengths and all presentations including a) L-Glut-100 mg-30 mL, b) L-Glut-200 mg/30 mL, c) Glutathione 200 mg/ML P.F. 10 mL, d) L-Glutathione-200-30 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Biotin Injection Due to Sterility Concerns
Green Valley Drugs is recalling Biotin Injection products because the pharmacy could not ensure the sterility of the compounded items.
Product
Biotin Injection, all strengths and all presentations including Biotin-15-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Human Chorionic Gonadotropin Injections for Sterility Concerns
Green Valley Drugs is recalling Human Chorionic Gonadotropin (HCG) injections due to a lack of assurance of sterility in its compounding and quality control processes.
Product
Human Chorionic Gonadotropin Injection, all strengths and all presentations including a) HCG 1000u/mL, b) HCG 1000u/mL 10mL, c) HCG 1000u Folic 400 mcg Methyl 5 mg 10 mL, d) HCG Kit 1 Day w/ Drug; HCT 750u/0.75 mL Pre-Filled Syringe, e) HCG Syringe 150iu/0.15 mL, f) HCG 1500u/1.5
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Edetate Disodium Injection Due to Sterility Concerns
Green Valley Drugs is recalling Edetate Disodium Injection because the pharmacy could not ensure the sterility of the compounded products.
Product
Edetate Disodium Injection, all strengths and all presentations including a) Edetate Disodium 150/30 mL and b) Edetate Disodium 150/100 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Pyridoxine Hydrochloride Injection for Sterility Concerns
Green Valley Drugs is recalling Pyridoxine Hydrochloride Injection due to lack of assurance of sterility and quality control concerns.
Product
Pyridoxine Hydrochloride Injection, all strengths and all presentations including Pyridoxine 100 mg/mL 30 mL, 50 mL, and 10 mL PF SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls BET-ACE-LIDO-6-2 Injection Due to Sterility Concerns
Green Valley Drugs is recalling BET-ACE-LIDO-6-2 Injection products because the pharmacy could not ensure the sterility of the compounded items.
Product
BET-ACE-LIDO-6-2 Injection, all strengths and all presentations including 7 mL syringe and Betameth Combo 6 mg/mL Lidocaine 2% Syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Methylprednisolone and Dexamethasone Injections for Sterility Concerns
Green Valley Drugs is recalling Methylprednisolone and Dexamethasone Injections due to a lack of assurance of sterility in its compounding and quality control processes.
Product
Methylprednisolone and Dexamethasone Injection, all strengths and all presentations including a) Methylpred/ Dexameth 1-2-3 mL and b) Methylpred/Dexa 3 mL PFS; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Buprenorphine Injection Due to Sterility Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling Buprenorphine Injection due to lack of assurance of sterility and quality control concerns.
Product
Buprenorphine Injection, all strengths and all presentations including Buprenorphine-0.3 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Testosterone Injections Due to Sterility Concerns
Green Valley Drugs is recalling 51 vials of Testosterone Cypionate and Testosterone Propionate Injection due to lack of assurance of sterility.
Product
Testosterone Cypionate and Testosterone Propionate Injection, all strengths and all presentations including a) Testosterone cyp 200/test prop 20 mg 10 mL and b) Testosterone Cyp 200 mg/Test Prop 50 mg 10mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 8901
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Taurine Injection Due to Sterility Concerns
Green Valley Drugs is recalling Taurine Injection products because the compounding pharmacy lacked assurance of sterility and had quality control concerns.
Product
Taurine Injection, all strengths and all presentations including a) Taurine 50 mg/mL, b) Taurine-50-30 mL, c) Taurine-50 mg-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Estradiol Valerate Injection Due to Sterility Concerns
Green Valley Drugs is recalling Estradiol Valerate Injection vials because the pharmacy could not ensure the products were sterile. This affects 243 vials distributed nationwide.
Product
Estradiol Valerate Injection, all strengths and all presentations including a) Estradiol Valerate 40-10 mL and b) Estradiol Valerate 40-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Testosterone Cypionate Injection Due to Sterility Concerns
Green Valley Drugs is recalling Testosterone Cypionate Injection vials and syringes because the compounding pharmacy could not ensure the products were sterile.
Product
Testosterone Cypionate Injection, all strengths and all presentations including a) Testosterone Cyp 200 mg/10 mL; b) Testosterone Cypionate 100 mg/10mL; c) Testosterone Cypionate 200 mg 10 mL; d) Testosterone Cypionate 200 mg 30 mL; e) Testosterone Cypionate 200 mg/mL; f) Testo
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