The Recall Desk

Archive

May 2013 recalls

607 recalls were announced in May 2013.

What the numbers show

Critical
23
Severe
197
High
166
Moderate
184
Low
37

Of the 607 recalls this month scored against our rubric, 4% are Critical, 32% are Severe.

Which agencies issued them

101–200 of 607

  • ModerateFDA (Devices)·Z-1360-2013·2013-05-29

    Progressive Medical Recalls PTFE Coated Laparoscopic Electrosurgical Electrodes

    Progressive Medical is recalling PTFE coated laparoscopic electrosurgical electrodes because the product coatings require 510K approval.

    Product
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated J Hook 33cm Length, Product number P0021, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Elect
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1426-2013·2013-05-29

    Clement Pappas Recalls Organic Apple Juice Due to Patulin Levels

    Clement Pappas & Co., Inc. is recalling Best Choice Clearly Organic Organic Apple Juice because the apple juice concentrate ingredient contained patulin levels between 57.4 and 100 ppb.

    Product
    Best Choice Clearly Organic Organic Apple Juice Net Wt 64 FL OZ (2 QT) 1.89 L UPC 070038614395 Proudly Distributed By : Associated Wholesale Grocers Inc., Kansas City, Kansas 66106
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-425-2013·2013-05-29

    Levoxyl Levothyroxine Sodium Tablets Recalled for Low Potency

    King Legacy is recalling Levoxyl tablets because they were below specification for potency at the expiry stability point.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-446-2013·2013-05-29

    Lloyd Inc. Recalls Levothroid Tablets Due to Stability Failures

    Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium) tablets due to cGMP deviations and insufficient stability data.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 112 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1330-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-423-2013·2013-05-29

    Levoxyl tablets recalled for subpotent drug levels

    King Legacy is recalling Levoxyl tablets because they were below specification for potency at the expiry stability point.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-426-2013·2013-05-29

    Levoxyl Levothyroxine Sodium Tablets Recalled for Subpotency

    King Legacy is recalling Levoxyl tablets because they were below specification for potency at the expiry stability point.

    Product
    LEVOXYL — LEVOXYL (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-442-2013·2013-05-29

    Lloyd Inc. Recalls Thyro-Tab Tablets Due to Quality Deviations

    Lloyd Inc. of Iowa is recalling bulk Thyro-Tab tablets due to cGMP deviations and stability failures. The product was repackaged and distributed nationwide.

    Product
    Lloyd Thyro-Tab 0.150 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1354-2013·2013-05-29

    Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes

    Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.

    Product
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Blade 2.50" (6.40cm) Length, Product number P0012M Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1351-2013·2013-05-29

    Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes

    Progressive Medical Inc is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.

    Product
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Blade 2.50" (6.40) Length, Product number P0012, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1357-2013·2013-05-29

    Progressive Medical Recalls PTFE Coated Laparoscopic Electrosurgical Electrodes

    Progressive Medical is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.

    Product
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Spatula 33cm Length, Product number P0018 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1416-2013·2013-05-29

    Greenway Organic Apple Juice Recalled for Patulin Contamination

    Clement Pappas & Co. is recalling Greenway Organic Apple Juice From Concentrate because the ingredient was found to contain patulin levels between 57.4 and 100 ppb.

    Product
    Greenway Organic Apple Juice From Concentrate 64 FL Oz (2 QTS) 1.89L UPC 70625348405 Distributed by OnPoint Inc. 2 Paragon Drive Montvale, NJ 07645
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-447-2013·2013-05-29

    Lloyd Inc. Recalls Levothroid Tablets Due to Quality Deviations

    Lloyd Inc. of Iowa is recalling Levothroid (levothyroxine sodium) tablets due to cGMP deviations and insufficient stability data.

    Product
    Levothroid (levothyroxine sodium tablets, USP) , 125 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1324-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1359-2013·2013-05-29

    Progressive Medical Recalls PTFE Coated Disposable Electrosurgical Electrodes

    Progressive Medical Inc. is recalling PTFE Coated Disposable Electrosurgical Electrodes because the product coatings require 510K approval.

    Product
    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook Split 33cm Length,Product number P0020S Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1423-2013·2013-05-29

    Wegmans Organic Cranberry Juice Blend Recalled for Patulin Contamination

    Clement Pappas & Co. is recalling Wegmans Organic Cranberry Juice Blend because an ingredient contained patulin levels between 57.4 and 100 ppb.

    Product
    Wegmans Organic Cranberry Juice Blend 64 FL OZ (2 QT) 1.89 L UPC 077890266892 Distributed by: Wegmans Food Markets, Inc. Rochester, NY 14603
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1428-2013·2013-05-29

    Organic Apple Juice Recalled for Patulin Contamination

    Clement Pappas & Co. is recalling specific lots of Nature's Promise Organic Apple Juice because the apple juice concentrate ingredient contained patulin levels between 57.4 and 100 ppb.

    Product
    1) Organics Nature's Promise Organic Apple Juice 64 FL OZ (2 QT) 1.89L UPC 688267036156 Distributed by Foodhold USA LLC Landover, MD 20785 1-877-846-9949 2) Organics Nature's Promise Organic Apple Juice 6.75 FL OZ (200 mL) UPC 688267063107 Distributed by Foodh
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-452-2013·2013-05-29

    Mylan Recalls Budesonide Capsules Due to Dissolution Testing Failures

    Mylan Institutional, Inc. is recalling 1,621 boxes of Budesonide Capsules, 3 mg, because routine stability testing showed out-of-specification dissolution results.

    Product
    Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed by: UDL Laboratories, Inc., Rockford, IL 61103, ND
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1337-2013·2013-05-29

    Ortho-Clinical Diagnostics Recalls VITROS CK-MB Calibrators Due to Invalid Results

    Ortho-Clinical Diagnostics is recalling VITROS CK-MB Calibrators because internal testing found that improperly stored units generated invalid calibrations.

    Product
    VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated Syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1179-2013·2013-05-29

    Chicago X-Ray Systems Recalls IntraOs 70 X-Ray Systems for Labeling Defects

    Chicago X-Ray Systems is recalling 1,960 IntraOs 70 intra-oral x-ray systems because they have missing or incomplete labels and user manual information.

    Product
    Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-420-2013·2013-05-29

    Novartis Recalls Lamisil AT Antifungal Cream Due to Illegible Labeling

    Novartis Consumer Health is recalling 3,828 tubes of Lamisil AT antifungal cream because the lot and expiration dates may be illegible.

    Product
    Lamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ 07054, NDC 0067-6171-85
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-419-2013·2013-05-29

    Rite Aid Tussin Cough Syrup Recalled for Precipitate Presence

    Aaron Industries is recalling Rite Aid brand Tussin Cough & Cold Mucus Relief CF due to the presence of white precipitate, identified as the active ingredient guaifenesin.

    Product
    Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1344-2013·2013-05-29

    Alere Recalls Cardinal Health hCG Cassette Rapid Test Due to Packaging Error

    Alere San Diego is recalling 2,167 Cardinal Health hCG Cassette Rapid Test kits because they were incorrectly packaged in boxes for a different test type.

    Product
    Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V223000·2013-05-28

    Triumph Recalls 2012-2013 Trophy Motorcycles Due to Fuel Tank Defect

    Triumph is recalling 2012-2013 Trophy and Trophy SE motorcycles because the fuel tank layers may fail to adhere, causing leaks that could lead to engine stalls or fires.

    Product
    TRIUMPH — TRIUMPH TROPHY SE, TROPHY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V222000·2013-05-28

    PACCAR Recalls 2014 Kenworth and Peterbilt Trucks for Ignition Switch Defect

    PACCAR is recalling specific 2014 Kenworth and Peterbilt trucks because an ignition switch defect can cause the engine to start unexpectedly, posing a risk of injury or crash.

    Product
    KENWORTH — KENWORTH, PETERBILT T880, T370, T660, T800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V221000·2013-05-28

    New Flyer Transit Buses Recalled for Defective Push-to-Start Switches

    New Flyer is recalling certain 2012-2013 transit buses because a weak spring in the push-to-start switch may allow the engine to start unexpectedly, posing an injury risk to nearby workers.

    Product
    NEW FLYER — NEW FLYER XD40, XN40, XD35, XD60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V220000·2013-05-24

    GM Recalls 9,677 Vehicles for Intermittent Brake Light Flashing

    General Motors is recalling 9,677 Cadillac and Chevrolet vehicles because brake lamps may flash without braking, increasing crash risk.

    Product
    CADILLAC — CADILLAC, CHEVROLET XTS, SONIC, ATS, IMPALA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E030000·2013-05-24

    BMW Recalls Dealer-Installed Luggage Racks for 2013 C650 GT Scooters

    BMW is recalling dealer-installed luggage racks for 2013 C650 GT Maxi-Scooters because attachment bolts may loosen, causing the rack to separate and create a road hazard.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V218000·2013-05-23

    Fleetwood Recalls 2013 Motorhomes Due to Incorrect Tire Load Index Labels

    Fleetwood is recalling 2013 Terra and Bounder Classic motorhomes because the tire load index on the certification tag is incorrect, which could lead to tire failure.

    Product
    FLEETWOOD — FLEETWOOD TERRA, BOUNDER CLASSIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13198·2013-05-23

    Nourison Recalls I-CANDI Area Rugs Due to Fire Hazard

    Nourison is recalling I-CANDI collection area rugs sold at Home Depot because they fail federal flammability standards, posing a fire hazard.

    Product
    Area Rugs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-328-2013·2013-05-22

    Evol Nutrition Recalls Mojo Nights for Her Due to Unapproved Ingredients

    Evol Nutrition is recalling Mojo Nights for Her capsules because they contain unapproved ingredients used to treat male erectile dysfunction.

    Product
    Mojo Nights for Her, 1 capsule, UPC 7 18122 12133 5, Distributed By: Mojo Health Lauderhill, FL 33351
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-336-2013·2013-05-22

    FDA Recalls Mojo Nights Capsules for Unapproved Active Ingredients

    Performance Plus Marketing is recalling Mojo Nights Capsules because they may contain undeclared sildenafil, tadalafil, and analogues, making them unapproved drugs.

    Product
    Mojo nights Capsules, Male Sexual Enhancer, supplied in 1 and 5 count blister packs, Distributed By: Mojo Health, Pompano Beach, FL I count blister UPC - 718122119738; 5 count blister UPC - 705105836430;
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-338-2013·2013-05-22

    Casanova Capsules Recalled for Undeclared Sildenafil and Tadalafil

    Performance Plus Marketing is recalling Casanova Capsules because they may contain undeclared sildenafil and tadalafil, making them unapproved drugs.

    Product
    CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister packs, UPC 736211906892; Distributed by: Casanova Distributors, Tucker, GA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1275-2013·2013-05-22

    Cook Medical Recalls Zilver PTX Drug-Eluting Peripheral Stent

    Cook Medical is recalling Zilver PTX Drug-Eluting Peripheral Stents due to delivery system fractures and tip separations that resulted in one death.

    Product
    Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an art
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-334-2013·2013-05-22

    FDA Recalls Blue Diamond Pill for Undeclared Sildenafil and Tadalafil

    Performance Plus Marketing, Inc. is recalling Blue Diamond Pill male sexual enhancement products because they may contain undeclared sildenafil, tadalafil, and analogues.

    Product
    BLUE Diamond Pill, supplied in 1, 5 and 10 count blister packs, Male Sexual Enhancement, Distributed By: DH Distribution Los Angeles, CA 90026. 1 count blister: UPC 705105524764, 5 count blister: UPC 736211124012, 10 count blister: UPC 736211123916.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-322-2013·2013-05-22

    Green Valley Drugs Recalls Cyanocobalamin Injection Due to Sterility Failure

    Green Valley Drugs is recalling Cyanocobalamin 1000 mcg/mL injection because testing revealed positive sterility results.

    Product
    Cyanocobalamin 1000 mcg/ml, injection 30 mL, MDV, For Office Use Only, Green Valley Drugs, Manufactured by Green Valley Drugs, Henderson, NV.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-325-2013·2013-05-22

    FDA Recalls Unapproved ROCK-IT MAN Male Sexual Stimulant Capsules

    Consumer Concepts is recalling ROCK-IT MAN capsules because FDA analysis found they contain an unapproved sildenafil analogue.

    Product
    ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447 02003 8) and 2-count (UPC 8 53447 00204 1) blister cards, Distributed by Consumer Concepts.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-335-2013·2013-05-22

    BLUE Diamond Platinum Capsules Recalled for Undeclared Active Ingredients

    Performance Plus Marketing is recalling BLUE Diamond Platinum Capsules because they may contain undeclared sildenafil, tadalafil, and analogues, making them unapproved drugs.

    Product
    BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By: DH Distribution Los Angeles, CA 90026 1 count blister UPC -608641933543; 5 count blister UPC - 608641932867; 10 count UPC -608641933536
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1274-2013·2013-05-22

    Cook Medical Recalls Zilver PTX Drug-Eluting Peripheral Stent Due to Catheter Fracture

    Cook Medical is recalling Zilver PTX Drug-Eluting Peripheral Stents because the delivery system's inner catheter can fracture or separate after deployment, a defect linked to one reported death.

    Product
    Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-321-2013·2013-05-22

    Green Valley Drugs Recalls Methylprednisolone Injectable Suspension Due to Sterility Failure

    Green Valley Drugs is recalling Methylprednisolone Preservative Free 40 mg/mL injectable suspension because testing revealed positive sterility results.

    Product
    Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension, 1 mL Vials and 2 mL Vials and 1 mL pre-filled syringes, For Office Use Only, Manufactured by Green Valley Drugs, Henderson, NV.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-323-2013·2013-05-22

    Super Power capsules recalled for containing unapproved sildenafil

    D& S Herbals, LLC is recalling Super Power capsules because they contain sildenafil, an unapproved drug ingredient.

    Product
    Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack, Distributed by: Freedom Trading, NJ 08863, UPC 7 18122 90678 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1384-2013·2013-05-22

    Heartland Gourmet Gluten-Free Cookie Mix Recalled for Undeclared Milk

    Heartland Gourmet is recalling gluten-free double chocolate cookie mix labeled as dairy-free because some products contain milk.

    Product
    Heartland Gourmet Gluten Free double chocolate cookie mix, DAIRY FREE, packaged in 16-oz. boxes. Manufactured by: Heartland Gourmet, LLC, Lincoln, NE.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-368-2013·2013-05-22

    Green Valley Drugs Recalls Gentamicin Injection Due to Sterility Concerns

    Green Valley Drugs is recalling 1,140 vials of Gentamicin Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    Gentamicin Injection, all strengths and all presentations including a) Gentamicin 40 mg/2 mL, b) Gentamicin 40 mg/30 mL, c) Gentamicin-40-20 mL, d) Gentamicin-40 mg/mL-2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-380-2013·2013-05-22

    Green Valley Drugs Recalls Lipotropic Injections Due to Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling 209 vials of Lipotropic With Vitamin Injections nationwide due to a lack of assurance of sterility.

    Product
    Lipotropic With Vitamin Injections, all strengths and all presentations including a) Lipo W/ Vitamin 100 mL, b) Lipo W/ Vitamins 30 mL, c) Lipo W/Vitamin, d) Lipo w/Vitamins #5 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereCPSC·13197·2013-05-22

    Insolroll Recalls Solar and Rechargeable Roller Shades Due to Fire Hazard

    Insolroll is recalling about 1,500 solar and rechargeable motor roller shades because the built-in lithium batteries can overheat and cause fires.

    Product
    Insolroll Solar Powered and Rechargeable Motor Roller Shades
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-347-2013·2013-05-22

    Green Valley Drugs Recalls BET-ACE-LIDO-6-2 Injection Due to Sterility Concerns

    Green Valley Drugs is recalling BET-ACE-LIDO-6-2 Injection products because the pharmacy could not ensure the sterility of the compounded items.

    Product
    BET-ACE-LIDO-6-2 Injection, all strengths and all presentations including 7 mL syringe and Betameth Combo 6 mg/mL Lidocaine 2% Syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1410-2013·2013-05-22

    Lisy Corp. Recalls Sazon Fajita Seasoning for Undeclared Soy Allergen

    Lisy Corp. is recalling Sazon Fajita seasoning in 5 oz, 14 oz, and 28 oz sizes because it contains undeclared soy. The product was distributed in 12 states.

    Product
    Sazon Fajita (Fajita Seasoning) in 5 oz, 14 oz, and 28 oz
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Food)·F-1342-2013·2013-05-22

    Centerville Pie Company Recalls Clam Pies Due to Undeclared Anchovies

    Centerville Pie Company is recalling 52 clam pies sold in Massachusetts because they contain undeclared anchovies, a potential allergen risk.

    Product
    Centerville Pie Company Clam Pie, 2 lb (Large) and 1 lb (Small)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-369-2013·2013-05-22

    Green Valley Drugs Recalls Glycerin/Lidocaine/Epinephrine Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Glycerin/Lidocaine/Epinephrine Injection because the pharmacy could not ensure the sterility of the compounded products.

    Product
    Glycerin/Lidocaine/Epinephrine Injection including Glycerin 72% Lido:Epi 2-1-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-372-2013·2013-05-22

    Green Valley Drugs Recalls Hydrochloric Acid Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Hydrochloric Acid Injection products because of a lack of assurance of sterility and quality control concerns.

    Product
    Hydrochloric Acid Injection, all strengths and all presentations including a) Hydrochloric Acid 0.6%, b) Hydrochloric Acid 2%, c) Hydrochloric Acid Injection 0.06% 30 mL, d) Hydrochloric Acid 2 mg/mL Injection 30 mL vial, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Hend
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-361-2013·2013-05-22

    Green Valley Drugs Recalls Edetate Disodium Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Edetate Disodium Injection because the pharmacy could not ensure the sterility of the compounded products.

    Product
    Edetate Disodium Injection, all strengths and all presentations including a) Edetate Disodium 150/30 mL and b) Edetate Disodium 150/100 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1391-2013·2013-05-22

    Eastland Food Recalls Asia Best Salted Mackerel Due to Histamine Levels

    Eastland Food Corporation is recalling 210 cases of Asia Best Salted Mackerel because histamine levels indicate product decomposition.

    Product
    Asia Best Salted Mackerel, 7 oz. vacuum packages, 25 pkgs/cases; labeled in part ***Eastland Food Corp. 8305 Stayton Drive Jessup, MD 20794 *** Product of Thailand *** Keep Frozen *** UPC 851035 408024***
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-386-2013·2013-05-22

    Green Valley Drugs Recalls Medroxyprogesterone Acetate Injection for Sterility Concerns

    Green Valley Drugs is recalling Medroxyprogesterone Acetate Injection due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    Medroxyprogesterone Acetate Injection, all strengths and all presentations including a) Medroxyprogesterone 150-30 mL, b) Medroxyprogesterone Acetate 150 mg/mL in 1 mL, 10 mL, 30 mL vials, c) Medroxyprogesterone Acetate 150 mg/mL PF syringe, d) Medroxyprogesterone Acetate 150 mg/
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-403-2013·2013-05-22

    Green Valley Drugs Recalls Pyridoxine Hydrochloride Injection for Sterility Concerns

    Green Valley Drugs is recalling Pyridoxine Hydrochloride Injection due to lack of assurance of sterility and quality control concerns.

    Product
    Pyridoxine Hydrochloride Injection, all strengths and all presentations including Pyridoxine 100 mg/mL 30 mL, 50 mL, and 10 mL PF SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1407-2013·2013-05-22

    Lisy Corp. Recalls Adobo con Pimienta for Undeclared Soy Allergen

    Lisy Corp. is recalling Adobo con pimienta in 5 oz, 14 oz, and 32 oz containers due to an undeclared soy allergen. The product was distributed in 12 states.

    Product
    Adobo con pimienta (Adobo with pepper) in 5 oz, 14 oz, and 32 oz
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-402-2013·2013-05-22

    FDA Recalls Green Valley Drugs Progesterone Injection for Sterility Concerns

    Green Valley Drugs is recalling all Progesterone Injection products due to a lack of assurance of sterility and quality control concerns.

    Product
    Progesterone Injection, all strengths and all presentations including a) Progesterone 100 mg/mL 10 mL, 30 mL b) Progesterone 50 mg/mL 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-375-2013·2013-05-22

    Green Valley Drugs Recalls Hydroxyprogesterone Caproate Injection Due to Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling 229 vials of Hydroxyprogesterone Caproate Injection nationwide due to lack of assurance of sterility.

    Product
    Hydroxyprogesterone Caproate Injection, all strengths and all presentations including Hydroxyprogesterone Caproate 250 mg/mL 1 mL, 4 mL, 5 mL, 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1385-2013·2013-05-22

    Heartland Gourmet Gluten Free Cookie Mix Recalled for Undeclared Milk

    Heartland Gourmet is recalling specific lots of gluten-free chocolate chip cookie mix labeled as dairy-free because they contain milk.

    Product
    Heartland Gourmet Gluten Free chocolate chip cookie mix, DAIRY FREE, packaged in 16-oz. boxes. Manufactured by: Heartland Gourmet, LLC, Lincoln, NE.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-362-2013·2013-05-22

    Green Valley Drugs Recalls Edetate Calcium Disodium Injection for Sterility Concerns

    Green Valley Drugs is recalling Edetate Calcium Disodium Injection due to a lack of assurance of sterility in its quality control processes.

    Product
    Edetate Calcium Disodium Injection, all strengths and all presentations including a) Edetate Calcium Disodium 300 mg/mL 100 mL, b) Edetate Calcium Disodium 300-30 mL, c) Calcium Edetate 200 mg/mL 15 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-333-2013·2013-05-22

    FDA Recalls Unapproved Libigrow XXXTREME Capsules Containing Undeclared Ingredients

    The FDA is recalling Libigrow XXXTREME Capsules because they were marketed without approval and may contain undeclared sildenafil, tadalafil, and analogues.

    Product
    libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By Kretek International, Inc. Moorpark, CA 930210 1 count blister: UPC 705105830735, 5 count blister: UPC 610585435939, 10 count blister: UPC 610585435922
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-358-2013·2013-05-22

    Green Valley Drugs Recalls Dexpanthenol Injection Due to Sterility Concerns

    Green Valley Drugs is recalling 273 vials of Dexpanthenol Injection nationwide due to a lack of assurance of sterility and quality control concerns.

    Product
    Dexpanthenol Injection, all strengths and all presentations including Dexpanthenol 250 mg/30 mL; Dexpanthenol 250 mg/mL 10 mL, 30 mL, 50 mL; and Dexpanthenol 250 mg/mL 10 mL P.F.; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-395-2013·2013-05-22

    Green Valley Drugs Recalls MIC Vitamin Injections Due to Sterility Concerns

    Green Valley Drugs is recalling 588 vials and syringes of MIC Vitamin Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    MIC Vitamin Injection, all strengths and all presentations including a) MIC 25-50-25-30 mL, b) MIC_B_COMP-B12-25-50-50-1000-30 mL, c) MIC_B12-25-50-25-400-30 mL, d) MIC_B6_B12-30 mL, e) MIC_METH_VIT-#3-30 m, f) MIC_METH-25-50-50-1000 mcg 30 mL, g) MIC_ULTRA-30 mL, h) MIC_VIT_METH
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-342-2013·2013-05-22

    Green Valley Drugs Recalls Ascorbic Acid Injection Due to Sterility Concerns

    Green Valley Drugs is recalling 2,682 vials of Ascorbic Acid Injection nationwide due to a lack of assurance of sterility and quality control concerns.

    Product
    Ascorbic Acid Injection, all strengths and all presentations including a) 500 mg/mL, b) corn source 500 mg/mL, c) tapioca 500 mg/mL, d) cassave 500; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-417-2013·2013-05-22

    NuVision Pharmacy Recalls Methylcobalamin Injection Due to Sterility Concerns

    NuVision Pharmacy is recalling 32 vials of Methylcobalamin Injection due to lack of assurance of sterility and reports of adverse events.

    Product
    Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-412-2013·2013-05-22

    Green Valley Drugs Recalls Sterile Testosterone and Nandrolone Injections

    Green Valley Drugs is recalling specific lots of sterile hormone injections due to a lack of assurance of sterility and quality control concerns.

    Product
    Testosterone Propionate, Testosterone Cypionate, and Nandrolone Decanoate Injection, all strengths and all presentations including Test Prop 100 mg/Test Cyp 50 mg/nandro dec 150 mg/ml, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-381-2013·2013-05-22

    Green Valley Drugs Recalls Lipotropic Injections Due to Sterility Concerns

    Green Valley Drugs is recalling 176 vials of Lipotropic With Vitamins with Methylcobalamin Injections nationwide due to a lack of assurance of sterility.

    Product
    Lipotropic With Vitamins with Methylcobalamin Injections, all strengths and all presentations including a) Lipo w/Vitamins-methylcobalamin 100 mL, 30 mL, and b) Lipo w/ Vitamins, Folic, Methylcobalamin 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-377-2013·2013-05-22

    Green Valley Drugs Recalls L-Carnitine Injection Due to Sterility Concerns

    Green Valley Drugs is recalling L-Carnitine Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    L-Carnitine Injection, all strengths and all presentations including L-Carnitine 500 mg/mL 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-388-2013·2013-05-22

    Green Valley Drugs Recalls Methylprednisolone and Marcaine Injections for Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling 607 vials of Methylprednisolone Acetate and Marcaine Injection due to lack of assurance of sterility and quality control concerns.

    Product
    Methylprednisolone Acetate and Marcaine Injection, all strengths and all presentations including a) Methylpred 80 mg/mL and Marcaine 0.25%-2.75, b) Methylpred_Marc-0.25-0.27, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-389-2013·2013-05-22

    Green Valley Drugs Recalls Methylprednisolone and Dexamethasone Injections for Sterility Concerns

    Green Valley Drugs is recalling Methylprednisolone and Dexamethasone Injections due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    Methylprednisolone and Dexamethasone Injection, all strengths and all presentations including a) Methylpred/ Dexameth 1-2-3 mL and b) Methylpred/Dexa 3 mL PFS; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-373-2013·2013-05-22

    Green Valley Drugs Recalls Hydrogen Peroxide Injection Due to Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling Hydrogen Peroxide Injection due to a lack of assurance of sterility in compounded and repackaged products.

    Product
    Hydrogen Peroxide Injection, all strengths and all presentations including Hydrogen Peroxide 3% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-348-2013·2013-05-22

    Green Valley Drugs Recalls Betamethasone Sodium Phosphate Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Betamethasone Sodium Phosphate Injection because the pharmacy could not ensure the sterility of the compounded products.

    Product
    Betamethasone Sodium Phosphate Injection, all strengths and all presentations including 6 mg/2 mL PF and 6 mg/mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-337-2013·2013-05-22

    Mojo nights SUPREME Capsules Recalled for Undeclared Active Ingredients

    Performance Plus Marketing, Inc. is recalling Mojo nights SUPREME Capsules because the product was marketed without an approved NDA/ANDA and may contain undeclared sildenafil, tadalafil, and analogues.

    Product
    Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 count blister packs, UPC 610585435915; Distributed By: Mojo Health, Pompano Beach, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-384-2013·2013-05-22

    Green Valley Drugs Recalls Magnesium Sulfate Injection Due to Sterility Concerns

    Green Valley Drugs is recalling 529 vials of Magnesium Sulfate Injection because the pharmacy could not ensure the products were sterile.

    Product
    Magnesium Sulfate Injection, all strengths and all presentations including a) Magnesium Sulfate 50%; b) MAGNESIUM SULFATE 50% 50 mL, c) Magnesium Sulfate PF 50% 2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-378-2013·2013-05-22

    FDA Recalls L-Glutathione Injection Due to Sterility Assurance Concerns

    Green Valley Drugs is recalling L-Glutathione Injection vials because the FDA identified a lack of sterility assurance and quality control concerns.

    Product
    L-Glutathione Injection, all strengths and all presentations including a) L-Glut-100 mg-30 mL, b) L-Glut-200 mg/30 mL, c) Glutathione 200 mg/ML P.F. 10 mL, d) L-Glutathione-200-30 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-416-2013·2013-05-22

    Green Valley Drugs Recalls Zinc Sulfate Injection Due to Sterility Concerns

    Green Valley Drugs is recalling 208 vials of Zinc Sulfate Injection because the pharmacy could not ensure the products were sterile.

    Product
    Zinc Sulfate Injection, all strengths and all presentations including a) Zinc Sulfate 10 mg/mL 30 mL and b) Zinc Sulfate 1 mg/mL 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-392-2013·2013-05-22

    Green Valley Drugs Recalls Lipotropic Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Lipotropic With Vitamins, Carnitine, Chromium and Glutamine Injection because the pharmacy could not ensure the products were sterile.

    Product
    Lipotropic With Vitamins, Carnitine, Chromium and Glutamine Injection, all strengths and all presentations including Lipo W/Vitamin-Carn-Crom_Glut-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-356-2013·2013-05-22

    Green Valley Drugs Recalls Cyclosporine Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Cyclosporine Injection products due to a lack of assurance of sterility and quality control concerns.

    Product
    Cyclosporine Injection, all strengths and all presentations including Cyclosporine 2% Aqueous Solution 15 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-332-2013·2013-05-22

    FDA Recalls Libigrow Capsules for Undeclared Active Ingredients

    Performance Plus Marketing, Inc. is recalling Libigrow capsules marketed without FDA approval. The product may contain undeclared sildenafil, tadalafil, and analogues.

    Product
    libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs, Distributed By: H & K Nutraceuticals Los Angeles, CA 1 count blister: UPC 094922567611, 5 count blister: UPC 094922567628, 10 count blister: UPC 610585434253.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-387-2013·2013-05-22

    Green Valley Drugs Recalls Methylcobalamin Injections Due to Sterility Concerns

    Green Valley Drugs is recalling 1,343 vials of Methylcobalamin Injection nationwide because the pharmacy could not ensure the products were sterile.

    Product
    Methylcobalamin Injection, all strengths and all presentations including a) Methylcobalamin 1000 mcg/mL in 10 mL, 30 mL, 50 mL, 60 mL, b) Methylcobalamin 1000 mcg 30 mL, c) Methylcobalamin 5 mg/mL 30 mL, d) Methylcobalamin PF 1000 mcg/mL in 2 mL, 5 mL, 10 mL, Rx only, Green Valle
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1408-2013·2013-05-22

    Lisy Corp. Recalls Sazonador de Carnes Meat Seasoning for Undeclared Soy

    Lisy Corp. is recalling Sazonador de Carnes meat seasoning in 5 oz, 14 oz, and 28 oz sizes due to undeclared soy. The product was distributed in 12 states.

    Product
    Sazonador de Carnes (Meat Seasoning) in 5 oz, 14 oz, and 28 oz
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-344-2013·2013-05-22

    Green Valley Drugs Recalls Bacteriostatic Water for Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Bacteriostatic Water for Injection because the company cannot ensure the products are sterile.

    Product
    Bacteriostatic Water for Injection, all presentations including 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-351-2013·2013-05-22

    Green Valley Drugs Recalls Bupivacaine and Dexamethasone Injection for Sterility Concerns

    Green Valley Drugs is recalling Bupivacaine and Dexamethasone Injection due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    Bupivacaine and Dexamethasone Injection, all strengths and all presentations including Bupiv_Dexameth-0.25-10.5; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-379-2013·2013-05-22

    Green Valley Drugs Recalls Lidocaine Injections Due to Sterility Concerns

    Green Valley Drugs is recalling Lidocaine Injection products because the pharmacy could not ensure the sterility of the compounded and repackaged items.

    Product
    Lidocaine Injection, all strengths and all presentations including a) Lidocaine _HCl-0.5%, b) Lidocaine HCl, c) Lidocaine 1%, d) Lidocaine 1% 50 mL, e) Lidocaine 2 %, f) Lidocaine 2% 50 mL, g) Lidocaine 2% 50 mL MDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-357-2013·2013-05-22

    Green Valley Drugs Recalls Dexamethasone Sodium Phosphate Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Dexamethasone Sodium Phosphate Injection because the compounding pharmacy could not ensure the sterility of the products.

    Product
    Dexamethasone Sodium Phosphate Injection, all strengths and all presentations including a) Dexamethasone Sodium Phosphate 10 mg/1 mL, b) Dexamethasone Sodium Phosphate 10 mg/mL PF 1 mL, c) Dexamethasone Sodium Phosphate 4 mg/30 mL, d) Dexamethasone-4 mg/5 mL P.F., Rx only, Green
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-371-2013·2013-05-22

    Green Valley Drugs Recalls Hyaluronidase Injection Due to Sterility Concerns

    Green Valley Drugs is recalling 996 vials of Hyaluronidase Injection because the pharmacy could not ensure the products were sterile.

    Product
    Hyaluronidase Injection, all strengths and all presentations including a) Hyaluronidase 150u/mL, b) Hyaluronidase 150u/ml 1 mL PF, c) Hyaluronidase 150u/mL PF 1ml SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-354-2013·2013-05-22

    Green Valley Drugs Recalls Vitamin D3 Injections Due to Sterility Concerns

    Green Valley Drugs is recalling Vitamin D3 injections because the pharmacy could not ensure the products were sterile. The recall covers 18 vials distributed nationwide.

    Product
    Vitamin D3 Injection, all strengths and all presentations including a) Cholecalciferol D3 50,000iu 30 mL, b) Calcitriol D3 10,000iu, and c) Calcitriol D3 50,000iu, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-350-2013·2013-05-22

    Green Valley Drugs Recalls Biotin Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Biotin Injection products because the pharmacy could not ensure the sterility of the compounded items.

    Product
    Biotin Injection, all strengths and all presentations including Biotin-15-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-390-2013·2013-05-22

    Green Valley Drugs Recalls Methylprednisolone and Bupivacaine Injection Due to Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling Methylprednisolone and Bupivacaine Injection due to a lack of assurance of sterility and quality control concerns.

    Product
    Methylprednisolone and Bupivacaine Injection, all strengths and all presentations including Methylpred80mg/bupivacaine0.25% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-343-2013·2013-05-22

    Green Valley Drugs Recalls Betamethasone Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Betamethasone Acetate and Betamethasone Sodium Injection because the pharmacy lacked assurance of sterility in its quality control processes.

    Product
    Betamethasone Acetate and Betamethasone Sodium Injection, all strengths and all presentations including 6 mg/mL preservative free, 2 ml; 106 mg/mL 10 mL, and 6 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-349-2013·2013-05-22

    FDA Recalls Betamethasone Injection Due to Sterility Assurance Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling Betamethasone Combination with Lidocaine and Bupivacaine Injection due to lack of assurance of sterility.

    Product
    Betamethasone Combination with Lidocaine 1% and Bupivacaine 0.5 % Injection, all strengths and all presentations including a) Betameth combo 6 mg/mL lido 1% bup 0.5% syr; and b) Betameth Combo/Lidocaine 1%/ Bupivacaine 0.5% Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #18
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-414-2013·2013-05-22

    Green Valley Drugs Recalls Thiamine Hydrochloride Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Thiamine Hydrochloride Injection because the compounding pharmacy could not ensure the sterility of the products.

    Product
    Thiamine Hydrochloride Injection, all strengths and all presentations including a) Thiamine 100 mg/30 mL, b) Thiamine Hydrochloride 100 mg/mL with preservative 30 mL, c) Thiamine Hydrochloride 50 mg/mL with preservative 30 mL, d) Thiamine Hydrochloride 100 mg/mL preservative free
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-382-2013·2013-05-22

    Green Valley Drugs Recalls L-Lysine Injection Due to Sterility Concerns

    Green Valley Drugs is recalling L-Lysine Injection vials because the pharmacy could not ensure the products were sterile.

    Product
    L-Lysine Injection, all strengths and all presentations including a) L-Lysine_100-30 mL, b) L-Lysine_100 mg/30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-383-2013·2013-05-22

    Green Valley Drugs Recalls Magnesium Chloride Injection Due to Sterility Concerns

    Green Valley Drugs is recalling 197 vials of Magnesium Chloride Injection nationwide due to a lack of assurance of sterility and quality control concerns.

    Product
    Magnesium Chloride Injection, all strengths and all presentations including a) Magnesium Chloride 200 mg/50 mL and b) Magnesium Chloride 200 mg/mL 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-366-2013·2013-05-22

    Green Valley Drugs Recalls Folic Acid Injections Due to Sterility Concerns

    Green Valley Drugs is recalling 244 vials of Folic Acid Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    Folic Acid Injection, all strengths and all presentations including a) Folic Acid 10 mg/mL 30 mL; b) Folic Acid PF 10 mg/mL 2 mL and 5 mL; c) Folic Acid 20 mg/mL 30 mL; d) Folic Acid 5 mg/mL 5 mL, 10 ml and 30 mL Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-399-2013·2013-05-22

    Green Valley Drugs Recalls Phosphatidylcholine Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Phosphatidylcholine and Sodium Deoxycholate Injection due to a lack of assurance of sterility in compounded products.

    Product
    Phosphatidylcholine and Sodium Deoxycholate Injection, all strengths and all presentations including Phospha_Deoxy-35-30-50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-339-2013·2013-05-22

    FDA Recalls Acetylcysteine Injection Due to Sterility Assurance Concerns

    Green Valley Drugs is recalling Acetylcysteine Injection vials because the pharmacy could not ensure the products were sterile.

    Product
    Acetylcysteine Injection, all strengths and all presentations including 100 mg/mL in 30 mL vials and 200 mg/mL in 30 mL and 50 mL vials, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-340-2013·2013-05-22

    Green Valley Drugs Recalls Alpha Lipoic Acid Injection Due to Sterility Concerns

    Green Valley Drugs is recalling Alpha Lipoic Acid Injection vials because the pharmacy could not ensure the products were sterile.

    Product
    Alpha Lipoic Acid Injection, all strengths and all presentations including 25 mg/mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-370-2013·2013-05-22

    Green Valley Drugs Recalls Human Chorionic Gonadotropin Injections for Sterility Concerns

    Green Valley Drugs is recalling Human Chorionic Gonadotropin (HCG) injections due to a lack of assurance of sterility in its compounding and quality control processes.

    Product
    Human Chorionic Gonadotropin Injection, all strengths and all presentations including a) HCG 1000u/mL, b) HCG 1000u/mL 10mL, c) HCG 1000u Folic 400 mcg Methyl 5 mg 10 mL, d) HCG Kit 1 Day w/ Drug; HCT 750u/0.75 mL Pre-Filled Syringe, e) HCG Syringe 150iu/0.15 mL, f) HCG 1500u/1.5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-353-2013·2013-05-22

    Green Valley Drugs Recalls Buprenorphine Injection Due to Sterility Concerns

    FVS Holdings, Inc. dba. Green Valley Drugs is recalling Buprenorphine Injection due to lack of assurance of sterility and quality control concerns.

    Product
    Buprenorphine Injection, all strengths and all presentations including Buprenorphine-0.3 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
    Category
    Drug
    Distribution
    Distributed nationwide

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