Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-293-2013 | 04-17-2013 | Sodium Tetradecyl Sulfate for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 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. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 5 vials (30 mL each) | Class II | Terminated |
| D-273-2013 | 04-17-2013 | Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 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. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 401 vials (10 mL vials each) | Class II | Terminated |
| D-282-2013 | 04-17-2013 | Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 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. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 61 vials (5 mL and 10 mL vials) | Class II | Terminated |
| D-292-2013 | 04-17-2013 | HCG Lyophylized Powder 10,000 unit for Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | Lack of Sterility Assurance | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 1 vial (10 mL) | Class II | Terminated |
| D-294-2013 | 04-17-2013 | BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 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. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 1 vial (10 mL) | Class II | Terminated |
| D-279-2013 | 04-17-2013 | Phosphatidylcholine Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 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. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 5 vials (3 mL each) | Class II | Terminated |
| D-291-2013 | 04-17-2013 | Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 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. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 18 viasl (10 mL each) | Class II | Terminated |
| D-281-2013 | 04-17-2013 | Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 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. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 15 vials (10 mL each) | Class II | Terminated |
| D-270-2013 | 04-17-2013 | TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 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. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 380 vials (5 mL and 10 mL vials) | Class II | Terminated |
| D-276-2013 | 04-17-2013 | Methylcobalamin and Folic Acid Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 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. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 29 vials (9 mL and 30 mL) | Class II | Terminated |
| D-275-2013 | 04-17-2013 | Cyanocobalamin (CMP) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 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. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 15 vials ((30 mL each) | Class II | Terminated |
| D-277-2013 | 04-17-2013 | Progesterone in Olive Oil Injectable Balanced Solutions, Compounding Pharmacy a division ofAxium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 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. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 11 vials (10 mL each) | Class II | Terminated |
| D-280-2013 | 04-17-2013 | Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 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. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 10 vials (30 mL each) | Class II | Terminated |
| D-272-2013 | 04-17-2013 | Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 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. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 286 vials (30 mL vials each) | Class II | Terminated |
| D-271-2013 | 04-17-2013 | Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 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. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 326 vials (10 mL each) | Class II | Terminated |
| D-295-2013 | 04-17-2013 | Cyclosporin in Corn Oil Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 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. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / 1 vial (15 mL) | Class II | Terminated |
| D-289-2013 | 04-17-2013 | Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 | 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. | Axium Healthcare Pharmacy dba Balanced Solutions Compounding / | Class II | Terminated |
| D-1052-2014 | 04-15-2013 | Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244 | Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection. | NuVision Pharmacy, Inc. / 122 vials | Class I | Terminated |
| D-1066-2014 | 04-15-2013 | The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry. | Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection. | Apothecure, Inc / | Class II | Terminated |
| D-1051-2014 | 04-15-2013 | HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244 | Lack of Assurance of Sterility: The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection. | NuVision Pharmacy, Inc. / 285 vials | Class I | Terminated |
| D-299-2013 | 04-12-2013 | Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, 20-count tablets per carton, Distributed by: Laboratorios Norimex Co., San Diego, CA 92154, UPC 0 91965 02002 8. | Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico. | OPMX, LLC / 11,580 cartons | Class II | Terminated |
| D-300-2013 | 04-12-2013 | Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL/ 4 fl oz bottle, Distributed by Laboratorios Nordimex Co., San Diego, CA 92154, UPC 0 91965 02001 1. | Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico. | OPMX, LLC / 7,610 bottles | Class II | Terminated |
| D-400-2013 | 04-10-2013 | Polidocanol Injection, all strengths and all presentations including a) Polidocanol 5% 30 mL, b) Polidocanol 1% 30 mL, c) Polidocanol 2% 30 mL, d) Polidocanol 3% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 109 vials | Class II | Terminated |
| D-386-2013 | 04-10-2013 | 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/mL syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 1299 vials and syringes | Class II | Terminated |
| D-344-2013 | 04-10-2013 | Bacteriostatic Water for Injection, all presentations including 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 597 vials | Class II | Terminated |
| D-394-2013 | 04-10-2013 | Metoprolol Injection, all strengths and all presentations including Metoprolol 1 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 65 vials | Class II | Terminated |
| D-416-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 208 vials | Class II | Terminated |
| D-377-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 65 vials | Class II | Terminated |
| D-382-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 132 vials | Class II | Terminated |
| D-348-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 65 vials | Class II | Terminated |
| D-398-2013 | 04-10-2013 | Phenylephrine Injection, all strengths and all presentations including Phenylephrine 1% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 54 vials | Class II | Terminated |
| D-373-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 140 vials | Class II | Terminated |
| D-396-2013 | 04-10-2013 | Modified Myers Cocktail Injection, all strengths and all presentations including a) Mod Meyer's Cocktail 37 mL and b) Modified Myers Cocktail 37 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 70 vials | Class II | Terminated |
| D-360-2013 | 04-10-2013 | Dimethyl Sulfoxide (DMSO) Injection, all strengths and all presentations including DMSO 99% 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / unknown | Class II | Terminated |
| D-368-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 1140 vials | Class II | Terminated |
| D-387-2013 | 04-10-2013 | 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 Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 1343 vials | Class II | Terminated |
| D-411-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 50 vials | Class II | Terminated |
| D-353-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 2 vials | Class II | Terminated |
| D-403-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 319 vials | Class II | Terminated |
| D-357-2013 | 04-10-2013 | 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 Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 4399 vials | Class II | Terminated |
| D-352-2013 | 04-10-2013 | Bupivacaine Injection, all strengths and all presentations including a) Bupivacaine Parabens Free 0.5% 50 mL, and b) Bupivacaine PF 0.5% 30 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 756 vials | Class II | Terminated |
| D-388-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 607 vials | Class II | Terminated |
| D-345-2013 | 04-10-2013 | B-Complex Injection, all strengths and all presentations including a) B-Complex Injection 30 mL; b) B-Complex PF 2 mL; c) B-Complex Plus-100; d) B-Complex_B12_30 mL; e) B-Complex-50-Methyl-30-Lido 30 mL; f) B-CompSuper-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 679 vials | Class II | Terminated |
| D-372-2013 | 04-10-2013 | 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, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 63 vials | Class II | Terminated |
| D-395-2013 | 04-10-2013 | 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_CARN-12.5-25-25-1-25-30 mL, i) MIC-25-50-25 Cyano 1000 mcg/mL 30 mL, j) MIC-25-50-50-30 mL, k) MIC-8-15-15-30, l) MIC-B12-30, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 588 vials and syringes | Class II | Terminated |
| D-015-2014 | 04-10-2013 | Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs, Manufactured by Dongseo Biopharm Corp., Yongin City, Kyonggi do, Korea, distributed by: Affirm XL, LLC, Ladera Ranch, CA | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug. | Affirm XL, Inc. / 400 pills | Class I | Terminated |
| D-391-2013 | 04-10-2013 | Methylprednisolone, Lidocaine, and Sodium Chloride Injection, all strengths and all presentations including a) Methylpred-Lido-Nacl-1-5-6-12 syringe and b) Methylpred80mg/lido1%/Sodium Chloride0.9% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 720 syringes | Class II | Terminated |
| D-370-2013 | 04-10-2013 | 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 mL Pre-Filled Syringe, g) HCG 5000 unit/5 mL vial, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 5255 vials and syringes | Class II | Terminated |
| D-380-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 209 vials | Class II | Terminated |
| D-342-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 2682 vials | Class II | Terminated |
| D-410-2013 | 04-10-2013 | 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 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 51 vials | Class II | Terminated |
| D-350-2013 | 04-10-2013 | Biotin Injection, all strengths and all presentations including Biotin-15-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 7 vials | Class II | Terminated |
| D-381-2013 | 04-10-2013 | 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 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 176 vials | Class II | Terminated |
| D-355-2013 | 04-10-2013 | Cyanocobalamin Injection, all strengths and all presentations including a) Cyanocobalamin 1000mcg, b) Cyanocobalamin 1000 mcg/mL in 1 mL, 10 mL, and 30 mL and 1 mL Preservative Free, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 6292 vials | Class II | Terminated |
| D-349-2013 | 04-10-2013 | 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, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 270 syringes | Class II | Terminated |
| D-361-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 98 vials | Class II | Terminated |
| D-364-2013 | 04-10-2013 | Estradiol Cypionate Injection, all strengths and all presentations including a) Estradiol Cypionate 5 mg/mL 10 mL and b) Estradiol Cypionate 10 mg/mL 10 ml, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 48 vials | Class II | Terminated |
| D-385-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 133 vials | Class II | Terminated |
| D-340-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 78 vials | Class II | Terminated |
| D-399-2013 | 04-10-2013 | 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. | 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.. | FVS Holdings, Inc. dba. Green Valley Drugs / 40 vials | Class II | Terminated |
| D-413-2013 | 04-10-2013 | 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) Testosterone Cypionate 200 mg/mL 30 mL; g) Testosterone Cypionate Sesame 200 mg/10 mL; h) Testosterone Cyp 250/30 mL; i) Testosterone Cypionate 200 mg/mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 3727 vials and syringes | Class II | Terminated |
| D-379-2013 | 04-10-2013 | 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, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 3946 vials | Class II | Terminated |
| D-354-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 18 vials | Class II | Terminated |
| D-409-2013 | 04-10-2013 | Sodium Tetradecyl Sulfate Injection, all strengths and all presentations including a) Sodium Tetradecyl Sulfate 3% 50 mL, b) Sodium Tetradecyl Sulfate 3% mL, c) Sodium Tetradecyl Sulfate-2% 30 mL, d) Sodium Tetradecyl Sulfate-2.5% 20 mL, e) Sodium Tetradecyl Sulfate 0.3% 30 mL, f) Sodium Tetradecyl Sulfate 1% 30 mL, 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 203 vials | Class II | Terminated |
| D-356-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 1 vial | Class II | Terminated |
| D-375-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 229 vials | Class II | Terminated |
| D-383-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 197 vials | Class II | Terminated |
| D-374-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 135 vials | Class II | Terminated |
| D-362-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 227 vials | Class II | Terminated |
| D-397-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 43 vials | Class II | Terminated |
| D-343-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 4368 vials | Class II | Terminated |
| D-359-2013 | 04-10-2013 | Dimercapto-propane-sulfonic acid (DMPS) Injection, all strengths and all presentations including a) DMPS 50 mg/5 mL, b) DMPS 50 mg/mL PF 5 mL, c) DMPS Acid 250 mg/5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 251 vials | Class II | Terminated |
| D-365-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 243 vials | Class II | Terminated |
| D-371-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 996 vials | Class II | Terminated |
| D-341-2013 | 04-10-2013 | Amikacin Injection, all strengths and all presentations including 50, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / unknown | Class II | Terminated |
| D-367-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 227 vials | Class II | Terminated |
| D-378-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 430 vials | Class II | Terminated |
| D-393-2013 | 04-10-2013 | Methylprednisolone Acetate Injection, all strengths and all presentations including a) Methylprednisolone Acetate 40 mg/mL, b) Methylprednisolone Acetate (PF) 40 mg/mL, c) Methylprednisolone Acetate (PF) 80 mg/mL, d) Methylpred Acetate 40 mg/mL 1 mL, e) Methylprednisolone 80 mg/5 mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 4350 vials and syringes | Class II | Terminated |
| D-346-2013 | 04-10-2013 | Betamethasone Combination Injection, all strengths and all presentations including a) Beta combo 6 mg/mL, 3 mL, b) Betameth_Combo_PF-6-2 Syr, and c) Betamethasone Combo 6 mg/mL Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 295 vials and syringes | Class II | Terminated |
| D-351-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 1150 vials | Class II | Terminated |
| D-414-2013 | 04-10-2013 | 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 10 mL and 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 70 vials | Class II | Terminated |
| D-406-2013 | 04-10-2013 | 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 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 5 vials | Class II | Terminated |
| D-401-2013 | 04-10-2013 | 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, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 70 vials | Class II | Terminated |
| D-369-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / unknown | Class II | Terminated |
| D-390-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 52 syringes | Class II | Terminated |
| D-376-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 3289 vials | Class II | Terminated |
| D-412-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 2 vials | Class II | Terminated |
| D-408-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 318 vials | Class II | Terminated |
| D-347-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 435 vials and syringes | Class II | Terminated |
| D-366-2013 | 04-10-2013 | 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 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 244 vials | Class II | Terminated |
| D-402-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 13 vials | Class II | Terminated |
| D-363-2013 | 04-10-2013 | ED Mix Injections, all strengths and all presentations including a) ED mix TM -at 2, b) ED-Mix BI-Mix 10 30 mL, c) ED-Mix BI-Mix 9 30 mL; d) ED-Mix BI-Mix-3-30, e) ED-Mix PGE 80-30, f) ED-Mix SB4 30 mL, g) Ed-Mix ST 9E, h) ED-Mix ST-1, i) ED-MIX T106, j) ED-MIX-PGE-150 30 mL, k) ED-MIX-PGE-40-30, l) ED-MIX-ST 9A, m) ED-MIX-ST 9D, n) ED-MIX-ST-9B, o) ED-MIX-T 101, p) ED-MIX-T105, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 10684 vials | Class II | Terminated |
| D-405-2013 | 04-10-2013 | Sodium Bicarbonate and Lidocaine Injection, all strengths and all presentations including Sod-Bicarb-Lido-0.27-2.73-3 syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 335 vials | Class II | Terminated |
| D-415-2013 | 04-10-2013 | Triamcinolone Injection, all strengths and all presentations including a) Triamcinolone 40 mg/1 mL PF, b) Triamcinolone Acetonide 45 mg/mL, c) Triamcinolone 50 mg/mL 5 mL PF, d) Triamcinolone 45 mg/mL10 mL, 30 mL, e) Triamcinolone 40 mg/mL SDV PF 1 mL, 2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 1423 vials | Class II | Terminated |
| D-339-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 93 vials | Class II | Terminated |
| D-404-2013 | 04-10-2013 | Sodium Chloride and Dexamethasone Injection, all strengths and all presentations including a) SOD_CHLOR-DEXAMETH-0.9-10-3, b) SOD_CHLORIDE/DEXAMETH syringe 0.9-10-3, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 950 syringes | Class II | Terminated |
| D-392-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 19 vials | Class II | Terminated |
| D-384-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 529 vials | Class II | Terminated |
| D-389-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 430 vials and syringes | Class II | Terminated |
| D-358-2013 | 04-10-2013 | 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. | 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. | FVS Holdings, Inc. dba. Green Valley Drugs / 273 vials | Class II | Terminated |
