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.

1–25 of 78

SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Methylcobalamin Injections Due to Sterility Concerns
Green Valley Drugs is recalling 1,343 vials of Methylcobalamin Injection nationwide because the pharmacy could not ensure the products were sterile.
Product
Methylcobalamin Injection, all strengths and all presentations including a) Methylcobalamin 1000 mcg/mL in 10 mL, 30 mL, 50 mL, 60 mL, b) Methylcobalamin 1000 mcg 30 mL, c) Methylcobalamin 5 mg/mL 30 mL, d) Methylcobalamin PF 1000 mcg/mL in 2 mL, 5 mL, 10 mL, Rx only, Green Valle
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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.
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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.
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SevereFDA (Drugs)··2013-05-22
FDA Recalls Acetylcysteine Injection Due to Sterility Assurance Concerns
Green Valley Drugs is recalling Acetylcysteine Injection vials because the pharmacy could not ensure the products were sterile.
Product
Acetylcysteine Injection, all strengths and all presentations including 100 mg/mL in 30 mL vials and 200 mg/mL in 30 mL and 50 mL vials, 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 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 free
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Folic Acid Injections Due to Sterility Concerns
Green Valley Drugs is recalling 244 vials of Folic Acid Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.
Product
Folic Acid Injection, all strengths and all presentations including a) Folic Acid 10 mg/mL 30 mL; b) Folic Acid PF 10 mg/mL 2 mL and 5 mL; c) Folic Acid 20 mg/mL 30 mL; d) Folic Acid 5 mg/mL 5 mL, 10 ml and 30 mL Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Magnesium Chloride Injection Due to Sterility Concerns
Green Valley Drugs is recalling 197 vials of Magnesium Chloride Injection nationwide due to a lack of assurance of sterility and quality control concerns.
Product
Magnesium Chloride Injection, all strengths and all presentations including a) Magnesium Chloride 200 mg/50 mL and b) Magnesium Chloride 200 mg/mL 50 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 L-Lysine Injection Due to Sterility Concerns
Green Valley Drugs is recalling L-Lysine Injection vials because the pharmacy could not ensure the products were sterile.
Product
L-Lysine Injection, all strengths and all presentations including a) L-Lysine_100-30 mL, b) L-Lysine_100 mg/30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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SevereFDA (Drugs)··2013-05-22
FDA Recalls Betamethasone Injection Due to Sterility Assurance Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling Betamethasone Combination with Lidocaine and Bupivacaine Injection due to lack of assurance of sterility.
Product
Betamethasone Combination with Lidocaine 1% and Bupivacaine 0.5 % Injection, all strengths and all presentations including a) Betameth combo 6 mg/mL lido 1% bup 0.5% syr; and b) Betameth Combo/Lidocaine 1%/ Bupivacaine 0.5% Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #18
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Betamethasone Injection Due to Sterility Concerns
Green Valley Drugs is recalling Betamethasone Acetate and Betamethasone Sodium Injection because the pharmacy lacked assurance of sterility in its quality control processes.
Product
Betamethasone Acetate and Betamethasone Sodium Injection, all strengths and all presentations including 6 mg/mL preservative free, 2 ml; 106 mg/mL 10 mL, and 6 mg/mL 5 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 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.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Bupivacaine and Dexamethasone Injection for Sterility Concerns
Green Valley Drugs is recalling Bupivacaine and Dexamethasone Injection due to a lack of assurance of sterility in its compounding and quality control processes.
Product
Bupivacaine and Dexamethasone Injection, all strengths and all presentations including Bupiv_Dexameth-0.25-10.5; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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0 states
SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Hyaluronidase Injection Due to Sterility Concerns
Green Valley Drugs is recalling 996 vials of Hyaluronidase Injection because the pharmacy could not ensure the products were sterile.
Product
Hyaluronidase Injection, all strengths and all presentations including a) Hyaluronidase 150u/mL, b) Hyaluronidase 150u/ml 1 mL PF, c) Hyaluronidase 150u/mL PF 1ml 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 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
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Betamethasone Sodium Phosphate Injection Due to Sterility Concerns
Green Valley Drugs is recalling Betamethasone Sodium Phosphate Injection because the pharmacy could not ensure the sterility of the compounded products.
Product
Betamethasone Sodium Phosphate Injection, all strengths and all presentations including 6 mg/2 mL PF and 6 mg/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 Hydrogen Peroxide Injection Due to Sterility Concerns
FVS Holdings, Inc. dba. Green Valley Drugs is recalling Hydrogen Peroxide Injection due to a lack of assurance of sterility in compounded and repackaged products.
Product
Hydrogen Peroxide Injection, all strengths and all presentations including Hydrogen Peroxide 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 L-Carnitine Injection Due to Sterility Concerns
Green Valley Drugs is recalling L-Carnitine Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.
Product
L-Carnitine Injection, all strengths and all presentations including L-Carnitine 500 mg/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 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.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Ascorbic Acid Injection Due to Sterility Concerns
Green Valley Drugs is recalling 2,682 vials of Ascorbic Acid Injection nationwide due to a lack of assurance of sterility and quality control concerns.
Product
Ascorbic Acid Injection, all strengths and all presentations including a) 500 mg/mL, b) corn source 500 mg/mL, c) tapioca 500 mg/mL, d) cassave 500; 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
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 89
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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) MIC_VIT_METH
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Edetate Calcium Disodium Injection for Sterility Concerns
Green Valley Drugs is recalling Edetate Calcium Disodium Injection due to a lack of assurance of sterility in its quality control processes.
Product
Edetate Calcium Disodium Injection, all strengths and all presentations including a) Edetate Calcium Disodium 300 mg/mL 100 mL, b) Edetate Calcium Disodium 300-30 mL, c) Calcium Edetate 200 mg/mL 15 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 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.
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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.
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SevereFDA (Drugs)··2013-05-22
Green Valley Drugs Recalls Magnesium Sulfate Injection Due to Sterility Concerns
Green Valley Drugs is recalling 529 vials of Magnesium Sulfate Injection because the pharmacy could not ensure the products were sterile.
Product
Magnesium Sulfate Injection, all strengths and all presentations including a) Magnesium Sulfate 50%; b) MAGNESIUM SULFATE 50% 50 mL, c) Magnesium Sulfate PF 50% 2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
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