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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-490-2013 | 04-22-2013 | Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / N/A | Class II | Terminated |
| D-483-2013 | 04-22-2013 | Methylcobalamin Inj 1mg/ml MDV, 10 ml, 15 ml, 20 ml, 30 ml, 4x30 ml Subcutaneous, 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 14 | Class II | Terminated |
| D-491-2013 | 04-22-2013 | Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 2 | Class II | Terminated |
| D-454-2013 | 04-22-2013 | Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 5 | Class II | Terminated |
| D-468-2013 | 04-22-2013 | Vancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 30 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / N/A | Class II | Terminated |
| D-453-2013 | 04-22-2013 | Bimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr Penile Injection,30 and 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 5 | Class II | Terminated |
| D-488-2013 | 04-22-2013 | Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular, 30 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 5 | Class II | Terminated |
| D-458-2013 | 04-22-2013 | PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 37 | Class II | Terminated |
| D-466-2013 | 04-22-2013 | Super Trimix #1 Inj MDV, 12 ml Penile Injection, 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 1 | Class II | Terminated |
| D-492-2013 | 04-22-2013 | M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 2 | Class II | Terminated |
| D-467-2013 | 04-22-2013 | Vancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 2 | Class II | Terminated |
| D-482-2013 | 04-22-2013 | Hydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / N/A | Class II | Terminated |
| D-485-2013 | 04-22-2013 | Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr Subcutaneous, 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 2 | Class II | Terminated |
| D-457-2013 | 04-22-2013 | PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / N/A | Class II | Terminated |
| D-487-2013 | 04-22-2013 | Methylcobalamin Inj 25mg/ml Syr: 8x0.06mlsyr, 10x0.06 ml syr, 12x0.06 ml syr Subcutaneous, 30 and 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 5 | Class II | Terminated |
| D-456-2013 | 04-22-2013 | Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 8 | Class II | Terminated |
| D-471-2013 | 04-22-2013 | Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / N/A | Class II | Terminated |
| D-486-2013 | 04-22-2013 | Methylcobalamin Inj 2.5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 3 | Class II | Terminated |
| D-495-2013 | 04-22-2013 | Pyridoxine 100mg/ml Inj MDV, 1X30 ml 30 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / N/A | Class II | Terminated |
| D-459-2013 | 04-22-2013 | PGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / N/A | Class II | Terminated |
| D-477-2013 | 04-22-2013 | HCG Inj 1200un/ml MDV, 10 ml Subcutaneous, 30 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 3 | Class II | Terminated |
| D-461-2013 | 04-22-2013 | Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 2 | Class II | Terminated |
| D-464-2013 | 04-22-2013 | Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 1 | Class II | Terminated |
| D-462-2013 | 04-22-2013 | Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 72 | Class II | Terminated |
| D-473-2013 | 04-22-2013 | Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 7 | Class II | Terminated |
| D-455-2013 | 04-22-2013 | Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 128 | Class II | Terminated |
| D-489-2013 | 04-22-2013 | Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / 2 | Class II | Terminated |
| D-463-2013 | 04-22-2013 | Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration, | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes. | Nora Apothecary and Alternative Therapies, Inc. / N/A | Class II | Terminated |
| D-420-2013 | 04-19-2013 | Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ 07054, NDC 0067-6171-85 | Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot. | Novartis Consumer Health / 3,828 Tubes | Class III | Terminated |
| D-0251-2015 | 04-19-2013 | Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64 u/mL, supplied in 11 mL Sterile Syringes, Rx only, Compounded med, Single use only, (Red Block) ABRAMS ROYAL Compounding Pharmacy, Dallas, TX | Non-Sterility | Abrams Royal Pharmacy / 50 syringes | Class I | Terminated |
| D-298-2013 | 04-19-2013 | GLIMEPIRIDE TABLETS USP, 2 mg, 100-count tablets per bottle, Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-3745-21. | Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level. | Qualitest Pharmaceuticals / 10,373 bottles | Class II | Terminated |
| D-268-2013 | 04-18-2013 | Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles. Package NDCs: 0781-2020-31; 0781-2020-76; 0781-2020-01; 0781-2020-05; 0781-2613-31; 0781-2613-76; 0781-2613-01; 0781-2613-05; 0781-5060-20; 0781-5060-01; 0781-5061-20; 0781-5061-01; 0781-6039-58; 0781-6039-46; 0781-6039-55; 0781-6156-52; 0781-6156-57; 0781-6156-46; 0781-6041-58; 0781-6041-46; 0781-6041-55; 0781-6157-52; 0781-6157-57; 0781-6157-46 | Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh. | Sandoz Incorporated / 8286 x 30 ct, 37108 x 500 ct. bottles | Class II | Terminated |
| D-286-2013 | 04-17-2013 | 17 Alpha Hydroxyprogesterone Caproate 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 / 4 vials (5 mL each) | Class II | Terminated |
| D-288-2013 | 04-17-2013 | DMSO 50% Sterile Bladder Irrigation Solution 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 / 2 50 mL vials | Class II | Terminated |
| D-284-2013 | 04-17-2013 | BiMix Plus 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 / 6 vials (5 mL and 10 mL each) | Class II | Terminated |
| D-287-2013 | 04-17-2013 | QuadMix 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 / 3 vials (10 mL each) | Class II | Terminated |
| D-278-2013 | 04-17-2013 | Cyclosporin (Grapeseed Oil) Ophthalmic 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 / 12 vials (15 mL each) | Class II | Terminated |
| D-274-2013 | 04-17-2013 | Triamcinolone Hexacetonide 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 / 28 vials (10 mL each) | Class II | Terminated |
| D-290-2013 | 04-17-2013 | Triamcinolone Diacetate 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 / 172 vials (5 mL vials each) | Class II | Terminated |
| D-285-2013 | 04-17-2013 | Quadmix Custom 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 / 3 vials (10 mL vials) | Class II | Terminated |
| D-1587-2014 | 04-17-2013 | NORepinephrine 4 mg in 250 mL Sodium Chloride0.9%, For IV Use Only, Flexible Bag, Rx only, UNIQUE PHARMACEUTICALS, Inc.Temple, TX USA 76502 | Lack of Assurance of Sterility: A mold like substance was discovered on the surface of an unopened bag of Sodium Chloride 0.9% while prepping the bag for production. | Unique Pharmaceutical, Ltd / 430 Bags | 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-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-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-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-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-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-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-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-283-2013 | 04-17-2013 | BiMix Standard 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
