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.

51–75 of 78

SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Nandrolone Decanoate Injection Due to Sterility Concerns
Green Valley Drugs is recalling Nandrolone Decanoate Injection because the pharmacy could not ensure the sterility of the compounded products.
Product
Nandrolone Decanoate Injection, all strengths and all presentations including a) Nandrolone Decanoate 300 mg/mL, b) Nandrolone 200 mg/mL, c) Nandrolone 250 mg/mL, d) Nandrolone 350 mg/mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Distribution
0 states
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.
Category
Distribution
0 states
SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls MIC Vitamin Injections Due to Sterility Concerns
Green Valley Drugs is recalling 588 vials and syringes of MIC Vitamin Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.
Product
MIC Vitamin Injection, all strengths and all presentations including a) MIC 25-50-25-30 mL, b) MIC_B_COMP-B12-25-50-50-1000-30 mL, c) MIC_B12-25-50-25-400-30 mL, d) MIC_B6_B12-30 mL, e) MIC_METH_VIT-#3-30 m, f) MIC_METH-25-50-50-1000 mcg 30 mL, g) MIC_ULTRA-30 mL, h)…
Category
Distribution
0 states
SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Manganese Sulfate Injection Due to Sterility Concerns
Green Valley Drugs is recalling Manganese Sulfate Injection because the pharmacy could not ensure the sterility of the compounded products.
Product
Manganese Sulfate Injection, all strengths and all presentations including a) Manganese-0.1 30 mL, b) Manganese Sulfate 0.1 mg/30 mL, c) Manganese Sulfate 5 mg/5 mg, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Distribution
0 states
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.
Category
Distribution
0 states
SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Thiamine Hydrochloride Injection Due to Sterility Concerns
Green Valley Drugs is recalling Thiamine Hydrochloride Injection because the compounding pharmacy could not ensure the sterility of the products.
Product
Thiamine Hydrochloride Injection, all strengths and all presentations including a) Thiamine 100 mg/30 mL, b) Thiamine Hydrochloride 100 mg/mL with preservative 30 mL, c) Thiamine Hydrochloride 50 mg/mL with preservative 30 mL, d) Thiamine Hydrochloride 100 mg/mL preservative…
Category
Distribution
0 states
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.
Category
Distribution
0 states
SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Dexamethasone Sodium Phosphate Injection Due to Sterility Concerns
Green Valley Drugs is recalling Dexamethasone Sodium Phosphate Injection because the compounding pharmacy could not ensure the sterility of the products.
Product
Dexamethasone Sodium Phosphate Injection, all strengths and all presentations including a) Dexamethasone Sodium Phosphate 10 mg/1 mL, b) Dexamethasone Sodium Phosphate 10 mg/mL PF 1 mL, c) Dexamethasone Sodium Phosphate 4 mg/30 mL, d) Dexamethasone-4 mg/5 mL P.F., Rx only, Green…
Category
Distribution
0 states
SevereFDA (Drugs)··2013-05-22
FDA Recalls Green Valley Drugs Progesterone Injection for Sterility Concerns
Green Valley Drugs is recalling all Progesterone Injection products due to a lack of assurance of sterility and quality control concerns.
Product
Progesterone Injection, all strengths and all presentations including a) Progesterone 100 mg/mL 10 mL, 30 mL b) Progesterone 50 mg/mL 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Distribution
0 states
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.
Category
Distribution
0 states
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…
Category
Distribution
0 states
SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Furosemide Injection Due to Sterility Concerns
Green Valley Drugs is recalling Furosemide Injection vials because the pharmacy could not ensure the products were sterile. The recall covers 227 vials distributed nationwide.
Product
Furosemide Injection, all strengths and all presentations including a) Furosemide PF-10 mg-10 mL, b) Furosemide PF-10 mg-2 mL SDV, and Furosemide 10 mg/mL 4 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Distribution
0 states
SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Procaine Hydrochloride Injection Due to Sterility Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling 70 vials of Procaine Hydrochloride Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.
Product
Procaine Hydrochloride Injection, all strengths and all presentations, including a) Procaine 2% 30 mL PF, b) Procaine HCl 2% 10 mL, c) Procaine HCl 20 mg/mL 30 mL, d) Procaine HCl 1% 50 mL MDV, e) Procaine HCl 1% PF 5 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa…
Category
Distribution
0 states
SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Sodium Chloride Injection Due to Sterility Concerns
Green Valley Drugs is recalling 318 vials of Sodium Chloride Injection due to a lack of assurance of sterility and quality control concerns.
Product
Sodium Chloride Injection, all strengths and all presentations including a) Bacteriostatic Sodium Chloride 0.9% 30 mL, b) Sodium Chloride 23.4% 30 mL PF, and c) Sodium Chloride 23.4% 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Distribution
0 states
SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Lipotropic Injections Due to Sterility Concerns
Green Valley Drugs is recalling 176 vials of Lipotropic With Vitamins with Methylcobalamin Injections nationwide due to a lack of assurance of sterility.
Product
Lipotropic With Vitamins with Methylcobalamin Injections, all strengths and all presentations including a) Lipo w/Vitamins-methylcobalamin 100 mL, 30 mL, and b) Lipo w/ Vitamins, Folic, Methylcobalamin 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV…
Category
Distribution
0 states
SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Hydroxocobalamin Injection Due to Sterility Concerns
Green Valley Drugs is recalling 135 vials of Hydroxocobalamin Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.
Product
Hydroxocobalamin Injection, all strengths and all presentations including a) Hydroxocobalamin 1000 mcg/mL 30mL and b) Hydroxocobalamin 1000 mcg/mL 10 mL P.F., Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Distribution
0 states
SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Hydroxyprogesterone Caproate Injection Due to Sterility Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling 229 vials of Hydroxyprogesterone Caproate Injection nationwide due to lack of assurance of sterility.
Product
Hydroxyprogesterone Caproate Injection, all strengths and all presentations including Hydroxyprogesterone Caproate 250 mg/mL 1 mL, 4 mL, 5 mL, 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Distribution
0 states
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.
Category
Distribution
0 states
SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Alpha Lipoic Acid Injection Due to Sterility Concerns
Green Valley Drugs is recalling Alpha Lipoic Acid Injection vials because the pharmacy could not ensure the products were sterile.
Product
Alpha Lipoic Acid Injection, all strengths and all presentations including 25 mg/mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Distribution
0 states
SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Amikacin Injection Due to Sterility Concerns
Green Valley Drugs is recalling Amikacin Injection because the pharmacy could not ensure the sterility of the compounded products. The recall covers all strengths and presentations of the drug.
Product
Amikacin Injection, all strengths and all presentations including 50, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Distribution
0 states
SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Methylprednisolone and Bupivacaine Injection Due to Sterility Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling Methylprednisolone and Bupivacaine Injection due to a lack of assurance of sterility and quality control concerns.
Product
Methylprednisolone and Bupivacaine Injection, all strengths and all presentations including Methylpred80mg/bupivacaine0.25% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Distribution
0 states
SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Ketorolac Injection Due to Sterility Concerns
Green Valley Drugs is recalling 3,289 vials of Ketorolac Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.
Product
Ketorolac Injection, all strengths and all presentations including a) Ketorolac 30 mg/mL 10 mL MDV, b) Ketorolac 30 mg/mL 2 mL SDV, c) Ketorolac 30 mg/mL 1 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Distribution
0 states
SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Nandrolone and Testosterone Injections for Sterility Concerns
Green Valley Drugs is recalling Nandrolone Decanoate and Testosterone Cypionate injections due to a lack of assurance of sterility and quality control concerns.
Product
Nandrolone Decanoate and Testosterone Cypionate Injection, all strengths and all presentations including a) Nandrolone 100 mg/mL TestCyp 100 mg/mL 10 mL and b) Nandrolone 100 mg/mL TestCyp 200 mg/mL 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV…
Category
Distribution
0 states
SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Sterile Testosterone and Nandrolone Injections
Green Valley Drugs is recalling specific lots of sterile hormone injections due to a lack of assurance of sterility and quality control concerns.
Product
Testosterone Propionate, Testosterone Cypionate, and Nandrolone Decanoate Injection, all strengths and all presentations including Test Prop 100 mg/Test Cyp 50 mg/nandro dec 150 mg/ml, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Distribution
0 states
SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Phosphatidylcholine Injection Due to Sterility Concerns
Green Valley Drugs is recalling Phosphatidylcholine and Sodium Deoxycholate Injection due to a lack of assurance of sterility in compounded products.
Product
Phosphatidylcholine and Sodium Deoxycholate Injection, all strengths and all presentations including Phospha_Deoxy-35-30-50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Category
Distribution
0 states