The Recall Desk

Archive

November 2014 recalls

908 recalls were announced in November 2014.

What the numbers show

Critical
20
Severe
183
High
251
Moderate
429
Low
25

Of the 908 recalls this month scored against our rubric, 2% are Critical, 20% are Severe.

Which agencies issued them

301–400 of 908

  • HighFDA (Devices)·Z-0172-2015·2014-11-12

    Stryker SmartLife Aseptic Housings Recalled for Welding Defect

    Stryker is recalling SmartLife Large Aseptic Housings because the top section may separate from the bottom due to insufficient welding.

    Product
    Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Hand
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0165-2015·2014-11-12

    Zimmer Surgical Recalls Universal Modular Electric Handpieces Due to Malfunction

    Zimmer Surgical Inc is recalling 828 Universal Modular Electric/Battery Handpieces because a malfunction allows them to start unexpectedly when connected to a power source.

    Product
    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2015·2014-11-12

    C.R. Bard Recalls 86 Non-Sterile Bard Dimension Stone Baskets

    C.R. Bard is recalling 86 non-sterile Bard Dimension Stone Baskets due to a Class II recall classification.

    Product
    Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle, s
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0169-2015·2014-11-12

    Cynosure Elite XPL Handpiece Recalled for Electrical Shock Risk

    Cynosure, Inc. is recalling 322 Elite XPL handpieces for the Elite MPX Laser System due to a potential risk of electrical shock when the device is adjusted or removed while powered on.

    Product
    Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0178-2015·2014-11-12

    Dokitz NovoSci Recalls Cardiopulmonary Bypass Connectors Due to Detachment Risk

    Dokitz NovoSci is recalling 240 units of cardiopulmonary bypass connectors because the single leg of the PAY connector has been observed to become detached.

    Product
    Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0085-2015·2014-11-12

    Baxter INTRA VIA Container Recalled for Particulate Matter in Fluid Path

    Baxter Healthcare is recalling 20,448 units of INTRA VIA containers due to particulate matter found inside the fluid path.

    Product
    Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0458-2015·2014-11-12

    United Natural Trading Recalls Asian 7 Rice Cracker Mix for Peanut Fragment

    United Natural Trading is recalling Asian 7 Rice Cracker Mix because a peanut fragment was found in the product. The recall affects 76 cases distributed in six states.

    Product
    The Market Basket Asian 7 Rice Cracker Mix Net Wt. 12 oz. (340 g) Distributed by Demondas Supermarkets, Inc. Tewksbury, MA 01876 UPC # 04970540898
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0456-2015·2014-11-12

    High Quality Organics Recalls Organic Ginger Tea Due to Salmonella

    High Quality Organics is recalling 780 lbs of Organic Ginger Tea Bag Cut after a sample tested positive for Salmonella.

    Product
    Organic Steam Treated Ginger Tea Bag Cut Item number 1641 USDA Organic Net Weight: 30 lbs. . High Quality Organics Reno, NV 89506
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0457-2015·2014-11-12

    Buddy's Kitchen Recalls Fiesta Breakfast Scramble Due to Listeria

    Buddy's Kitchen, Inc. is recalling Fiesta Breakfast Scramble because an ingredient tested positive for Listeria monocytogenes.

    Product
    Fiesta Breakfast Scramble, Product # 73EN510. Net Weight 11.4 lbs. 24 - 7.60 oz. portions. Keep Frozen. For Institutional Use Only. Production Facility Buddy's Kitchen, Inc., Burnsville, MN 55337
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0164-2015·2014-11-12

    Siemens Calibrator E Recalled for Positive Bias in Cortisol and Progesterone Assays

    Siemens Healthcare Diagnostics is recalling Calibrator E kits due to positive bias in Cortisol and Progesterone assays on ADVIA Centaur Systems.

    Product
    Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0464-2015·2014-11-12

    Mama Tere Sweet Corn Patties Recalled for Mislabeling

    Family Food Distributors, Inc. is recalling Mama Tere Arepa de Chocolo sweet corn patties because the products were found to be mislabeled.

    Product
    Mama Tere Arepa de Chocolo Sweet Corn Patty 10.5 oz/300g 4 units Product of Colombia Importado Por: Family Food Distributors, Inc. 969 Newark Turnpike, Unit D, Kearny, NJ 07032
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0176-2015·2014-11-12

    Beckman Coulter Recalls DxC 600i Analyzer Console PC Due to Error

    Beckman Coulter is recalling the Small Form Factor Console PC for the DxC 600i analyzer because it may experience an 'MFC Exception' error during normal operation.

    Product
    UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes con
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0241-2015·2014-11-12

    Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Apotex Inc. is recalling Candesartan Cilexetil Tablets, 4 mg, because out-of-specification results were observed for specific impurities and total impurities.

    Product
    Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0175-2015·2014-11-12

    Beckman Coulter Recalls Access 2 Immunoassay Systems Due to Software Error

    Beckman Coulter is recalling Access 2 Immunoassay Systems because the Small Form Factor Console PC may experience an 'MFC Exception' error during normal operation.

    Product
    Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte conce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0177-2015·2014-11-12

    St. Jude Medical Recalls Electrophysiology Catheters Due to Incorrect Packaging

    St. Jude Medical is voluntarily recalling 26 electrophysiology catheters because the packaging contains the wrong device model. No serious injuries have been reported.

    Product
    St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0174-2015·2014-11-12

    Straumann Dental Implant Recall Due to Incorrect Product Transfer Piece

    Straumann USA is recalling 111 units of Bone Level Implants because the product transfer piece was fitted with a Narrow Connect instead of a Regular Connect.

    Product
    Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0236-2015·2014-11-12

    Sun Pharma Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures

    Sun Pharma Global Inc. is recalling specific batches of Venlafaxine Hydrochloride Extended-Release Tablets because they failed dissolution specifications and a 12-month stability time point.

    Product
    Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0179-2015·2014-11-12

    Leica Thyroglobulin Antibody Recalled for Reduced Performance

    Leica Microsystems is recalling Thyroglobulin (1D4) antibodies because they may not function as intended up to the expiration date.

    Product
    Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. This reagent is for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Food)·F-0466-2015·2014-11-12

    Mama Tere Arepa de Moto Hominy Patties Recalled for Mislabeling

    Family Food Distributors, Inc. is recalling Mama Tere Arepa de Moto Hominy Patties because the product was found to be mislabeled.

    Product
    Mama Tere Arepa de Moto Hominy Patty 14.1 oz / 400 g 5 units Product of Colombia Importado Por: Family Food Distributors, Inc. 969 Newark Turnpike, Kearny, NJ 07032 UPC 812828011652
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0240-2015·2014-11-12

    Pharmaceutical Associates Recalls Cyproheptadine HCl Syrup Due to Impurity

    Pharmaceutical Associates Inc. is recalling 9,640 unit dose cups of Cyproheptadine HCl Syrup because an unidentified impurity exceeded specifications during stability testing.

    Product
    Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0162-2015·2014-11-12

    Merit Maestro Microcatheter Recalled for Incorrect Distal Tip Size

    Merit Medical Systems is recalling 56 Maestro Microcatheters because they were packaged with a 2.8 F distal tip instead of the labeled 2.4 F.

    Product
    Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0166-2015·2014-11-12

    Smiths Medical Recalls CADD-Solis Medication Safety Software Administrator CD

    Smiths Medical is recalling a specific lot of CADD-Solis Medication Safety Software Administrator CDs because they were shipped with incorrect software loaded.

    Product
    CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0465-2015·2014-11-12

    Mama Tere Arepa Products Recalled for Mislabeling

    Family Food Distributors, Inc. is recalling Mama Tere Arepa products due to mislabeling. The affected items were distributed in six states.

    Product
    Mama Tere Arepa de Blanca de Maiz White Corn Patty 14.1 oz/400g 5 units Product of Colombia Importado Por: Family Food Distributors, Inc. 969 Newark Turnpike, Kearny, NJ 07032 UPC 812828011676
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0237-2015·2014-11-12

    Physicians Total Care Recalls Cephalexin Capsules Due to Manufacturing Deviations

    Physicians Total Care is recalling specific lots of Cephalexin Monohydrate Capsules because the active ingredients were not manufactured with good manufacturing practices.

    Product
    CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for Caraco Pharmaceuticals, Detroit, MI 48202 by Sun Pharmaceuticals, Fort Worth, TX 76155 and repackaged by Physicians Total Care, Inc., Tulsa, OK 74146-6233
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0234-2015·2014-11-12

    Obagi Nu-Derm Clear Prescription Cream Recalled for Labeling Error

    Obagi Medical Products is recalling 975 bottles of Obagi Nu-Derm Clear due to a labeling mix-up where Exfoderm Forte contents were shipped.

    Product
    OBAGI NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION — OBAGI NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION (HYDROQUINONE, HOMOSALATE, OCTISALATE, ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0243-2015·2014-11-12

    Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Apotex Inc. is recalling Candesartan Cilexetil Tablets, 16 mg, because out-of-specification results were observed for specific impurities and total impurities.

    Product
    Candesartan Cilexetil Tablets, 16 mg, a) 30-count bottle (NDC 60505-3620-3) b) 90-count bottles (NDC 60505-3620-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0244-2015·2014-11-12

    Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Apotex Inc. is recalling Candesartan Cilexetil Tablets, 32 mg, because out-of-specification results were observed for specific impurities and total impurities.

    Product
    Candesartan Cilexetil Tablets, 32 mg, a) 30-count bottle (NDC 60505-3621-3) b) 90-count bottles (NDC 60505-3621-9) Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0242-2015·2014-11-12

    Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Apotex Inc. is recalling specific lots of Candesartan Cilexetil Tablets because they failed impurity and degradation specifications.

    Product
    Candesartan Cilexetil Tablets, 8 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3619-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0238-2015·2014-11-12

    Nanophase Recalls Z-COTE HP 1 Zinc Oxide Powder Due to Manufacturing Error

    Nanophase Technologies is recalling Z-COTE HP 1 Transparent Zinc Oxide powder because an incorrect amount of raw material was added during manufacturing.

    Product
    Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, Powder, NET: 22 KG, Packaged in double plastic liners in a single fiber carton, FOR MANUFACTURING, PROCESSING OR REPACKING, BASF Corporation, Florham Park, NJ
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0239-2015·2014-11-12

    Physicians Total Care Recalls Loratadine Tablets Due to Chipped or Broken Pieces

    Physicians Total Care is recalling specific lots of Loratadine 24 HR-OTC 10 mg tablets because they may contain chipped or broken pieces.

    Product
    Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consumer Health, Parsippany, NJ 07054, Distributed by Physicians Total Care, Tulsa OK 74146, NDC 54868-5268-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0235-2015·2014-11-12

    Pfizer Recalls TORISEL Kits Due to Diluent Crystallization

    Pfizer is recalling 16,000 TORISEL kits because impurities in the diluent may cause crystals to form after cold storage. The TORISEL drug vials are not affected.

    Product
    TORISEL — TORISEL (TEMSIROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V722000·2014-11-10

    Kenworth Heavy Trucks Recalled for Undersized Wire Gauge Fire Risk

    PACCAR is recalling 2015 Kenworth heavy trucks because an undersized wire in the instrument panel harness may overheat, increasing the risk of a vehicle fire.

    Product
    KENWORTH — KENWORTH T800, W900, T660, C500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V717000·2014-11-10

    Daimler Recalls 2014-2015 Freightliner Trucks Due to Brake Valve Defect

    Daimler is recalling 2014-2015 Freightliner trucks because defective air brake valves may reduce braking performance and increase crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER 122SD, ARGOSY, CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V719000·2014-11-10

    GM Recalls 2015 Trucks and SUVs for Power Steering Loss

    General Motors is recalling 2015 Chevrolet and GMC vehicles because a steering module defect may cause sudden loss of power assist, increasing crash risk.

    Product
    GMC — GMC, CHEVROLET YUKON, SUBURBAN, TAHOE, SILVERADO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15021·2014-11-10

    McDonald's Recalls Hello Kitty Whistles Due to Choking Hazard

    McDonald's is recalling Hello Kitty Birthday Lollipop Whistles because internal components can detach, posing choking and aspiration risks to young children.

    Product
    Hello Kitty® Birthday Lollipop Whistles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V718000·2014-11-10

    Sutphen Aerial Devices Recalled for Potential Ladder Cable Failure

    Sutphen is recalling 2000-2014 aerial devices because a cable failure could cause the ladder to collapse, increasing injury risk.

    Product
    SUTPHEN — SUTPHEN SPH 100, SPI 112, SP 110, SAI 110
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·077-2014·2014-11-09

    Kulana Foods Recalls Frozen Pork Products Due to Undeclared Wheat Allergen

    Kulana Foods is recalling approximately 4,465 pounds of frozen, fully cooked pork products because they contain wheat, a known allergen, that is not declared on the label.

    Product
    Kulana Foods, Ltd. — Hawaii Firm Recalls Frozen Pork Products Due To Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V716000·2014-11-07

    PACCAR Recalls Kenworth and Peterbilt Trucks Due to Brake Valve Defect

    PACCAR is recalling specific 2014-2015 Kenworth and Peterbilt trucks because defective parking brake valves may reduce braking performance and increase crash risk.

    Product
    KENWORTH — KENWORTH, PETERBILT K270, 220, K370, MODEL 220
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V712000·2014-11-07

    Forest River Recalls 2015 Wildwood and Salem Trailers for Draw Bar Defect

    Forest River is recalling 2015 Wildwood and Salem Ice Cabin trailers because the draw bar may break, potentially causing the trailer to detach from the vehicle.

    Product
    FOREST RIVER — FOREST RIVER WILDWOOD, SALEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V713000·2014-11-07

    Hyundai Recalls Genesis and Equus Vehicles for Stop Lamp Circuit Failure

    Hyundai is recalling 2009-2011 Genesis and 2011 Equus vehicles because a circuit failure may prevent stop lamps from illuminating, increasing the risk of a rear-end crash.

    Product
    HYUNDAI — HYUNDAI EQUUS, GENESIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V711000·2014-11-07

    Dodge Journey Recall for Inaccurate Tire Placard Weight Information

    Chrysler is recalling 2014-2015 Dodge Journey vehicles because tire placard labels may contain inaccurate weight and seating information, increasing crash risk.

    Product
    DODGE — DODGE JOURNEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·076-2014·2014-11-06

    CS Best Food Recalls Pork Sausage Links Due To Undeclared Allergens

    CS Best Food Inc. is recalling pork sausage links containing undeclared wheat and soy allergens. The products were distributed in California and Washington.

    Product
    CS Best Food, Inc. — California Firm Recalls Pork Products Due To Misbranding And Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0083-2015·2014-11-05

    WildForce Super Plant Protein Recalled for Potential Salmonella Contamination

    Herb Garden Productions is recalling WildForce Super Plant Protein because Nettle Leaf Powder may contain Salmonella.

    Product
    WildForce Super Plant Protein, 2 lbs (32 oz) Bottled in 2500cc food grade white plastic bottle. Manufacturer: Herbally Grounded LLC., Curtiss Harris 7023640090 3744 W. Meade Ave. Ste. 11a Las Vegas, NV 89102
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0081-2015·2014-11-05

    Herbally Grounded Hello Blossom Capsules Recalled for Salmonella Risk

    Herb Garden Productions is recalling Herbally Grounded Hello Blossom capsules because the nettle leaf powder ingredient may contain Salmonella.

    Product
    Herbally Grounded Hello Blossom 120 ct Vegetarian Capsule Formula, bottle in 20cc food grade amber glass bottle. Manufacturer: Herbally Grounded LLC., Curtiss Harris 7023640090 3744 W. Meade Ave. Ste. 11a Las Vegas, NV 89102
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0082-2015·2014-11-05

    Herb Garden Productions Recalls WildForce Green Formula Due to Salmonella Risk

    Herb Garden Productions is recalling WildForce Green Formula because Nettle Leaf Powder may contain Salmonella.

    Product
    WildForce Green Formula, The Power of Wild Plants, 430 grams. bottles in 2500cc food grade white plastic bottle. Manufacturer: Herbally Grounded LLC., Curtiss Harris 7023640090 3744 W. Meade Ave. Ste. 11a Las Vegas, NV 89102
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0084-2015·2014-11-05

    Jinga Panfried Anchovy Recall for Listeria Contamination

    Jinga brand Panfried Anchovies are being recalled due to Listeria monocytogenes contamination found by Virginia state officials.

    Product
    JINGA brand PANFRIED ANCHOVY(S), NET WT. 2 oz. and 4 oz., KEEP REFRIGERATED -- JINGA 44-28 55TH AVE., MASPETH, NY 11378 --- The product is packaged in clear, hard plastic containers.
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Drugs)·D-0230-2015·2014-11-05

    FDA Recalls Calcium Glucosate Injection Due to Microbial Contamination

    Specialty Compounding, LLC is recalling Calcium Gluconate 2 gm in 100 mL Sodium Chloride 0.9% for Injection due to non-sterility and microbial contamination.

    Product
    CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% for Injection, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0161-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Tri-mix T101, due to quality control observations that present a risk to sterility assurance.

    Product
    Tri-mix T101, 17.65 mg/0.59 mg/5.9 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0142-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tobramycin Eye Drops for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tobramycin eye drops due to quality control issues that may compromise sterility.

    Product
    Tobramycin (PF) 15 mg/mL opthalmic solution packaged in opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0112-2015·2014-11-05

    FDA Recalls 324 Puritan Bennett 980 Ventilators Due to Software Issue

    The FDA is recalling 324 Puritan Bennett 980 ventilators because a software issue may cause the devices to become inoperative.

    Product
    Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
    Category
    Medical Device
    Distribution
    17 states
  • SevereNHTSA·14V707000·2014-11-05

    Blue Bird Recalls 2015 Transit Buses Due to Fuel Filter Defect

    Blue Bird is recalling 2015 All American and Vision transit buses because a fuel filter defect may cause the engine to stall without warning, increasing crash risk.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V702000·2014-11-05

    Wabash National Van Trailer Recall for Cracking Pivot Bolts

    Wabash is recalling 2013 Van trailers because certain pivot bolts may crack, potentially causing the axle to separate and increasing crash risk.

    Product
    WABASH NATIONAL — WABASH NATIONAL VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0091-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Hydromorphone and Bupivacaine Injections

    Martin Avenue Pharmacy is voluntarily recalling compounded hydromorphone and bupivacaine injections due to quality control issues that may compromise sterility.

    Product
    Hydromorphone HCl/bupivacaine (PF) 10 mg/7.5 mg/mL injection packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0108-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including ophthalmic ointment base, due to quality control observations that risk sterility assurance.

    Product
    Opthalmic ointment base ointment packaged in a white ointment tube, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0058-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Atropine Sulfate Eye Drops for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Atropine sulfate 0.01% ophthalmic solution due to quality control issues that may compromise sterility.

    Product
    Atropine sulfate 0.01% opthalmic solution packaged in a squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0066-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Cefazolin Ophthalmic Solution for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Cefazolin ophthalmic solution due to quality control issues that may compromise sterility.

    Product
    Cefazolin forte 25 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0146-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.

    Product
    Tri-mix, 12 mg/1 mg/9 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0111-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including PGE 1, due to quality control observations that risk sterility assurance.

    Product
    PGE 1, 40 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0142-2015·2014-11-05

    Mabis Recalls DMI Rollator Transport Chairs Due to Collapse Risk

    Briggs Medical Service Company is recalling 1,869 DMI Rollator Transport Chairs because they may collapse during use.

    Product
    DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat Height: 21 1/4"; Seat Size: 14" x 12 3/4"; Handle Height: 31" - 36"; Width Between Handles: 18"; Weight: 19 Lbs; Walking assistance device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0112-2015·2014-11-05

    Martin Avenue Pharmacy Recalls PGE 2 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling PGE 2 injectable vials due to quality control issues affecting sterility assurance.

    Product
    PGE 2, 100 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0072-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including cyanocobalamin, due to quality control observations that risk sterility assurance.

    Product
    Cyanocobalamin 1000 mcg/mL injectable solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0122-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Polyhexamethylene Biguanide Eye Drops

    Martin Avenue Pharmacy is voluntarily recalling compounded polyhexamethylene biguanide eye drops due to quality control issues that risk sterility assurance.

    Product
    Polyhexamethylene biguanide 0.02% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0056-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Acetylcysteine Eye Drops Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Acetylcysteine 10% ophthalmic solution due to quality control issues that may compromise sterility.

    Product
    Acetylcysteine 10% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0055-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Acetylcysteine Inhalant Solution Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Acetylcysteine 20% inhalant solution due to quality control issues affecting sterility assurance.

    Product
    Acetylcysteine 20% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0071-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Cromolyn Sodium Inhalant Solution

    Martin Avenue Pharmacy is voluntarily recalling Cromolyn sodium 1% inhalant solution due to sterility assurance concerns identified during an FDA inspection.

    Product
    Cromolyn sodium 1% inhalant solution packaged in a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0088-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including hydromorphone/clonidine/bupivacaine, due to quality control observations that risk sterility assurance.

    Product
    Hydromorphone/clonidine/bupivacaine 12 mg/600 mcg/0.2 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0231-2015·2014-11-05

    Specialty Compounding Recalls All Prescription Products Due to Sterility Concerns

    Specialty Compounding, LLC is recalling all prescription products manufactured by the company due to a lack of assurance of sterility.

    Product
    All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0229-2015·2014-11-05

    Cubicin Injection Recalled for Foreign Particulate Matter in Vials

    Cubist Pharmaceuticals is recalling Cubicin (daptomycin) injection vials due to the presence of tiny black foreign particulate matter observed after reconstitution.

    Product
    CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manufactured for: Cubist Pharmaceuticals Inc., Lexington, MA 02421, USA, NDC 67919-011-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0107-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Injectable Preparations for Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile injectable preparations due to quality control observations that risk sterility assurance.

    Product
    "NB2014" 30 mg/6 mg/300 mcg/0.3 mg/mL (phentolamine mesylate, papaverine, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0154-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix SEST 4 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix SEST 4 injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Tri-mix SEST 4, 30 mg/1.5 mg/400 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0067-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Cefazolin Eye Drops Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Cefazolin eye drops because quality control issues may have compromised sterility.

    Product
    Cefazolin forte 50 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0233-2015·2014-11-05

    Actavis Recalls Subpotent Vancomycin Hydrochloride Capsules Nationwide

    Actavis Inc. is voluntarily recalling 46,676 cartons of Vancomycin Hydrochloride Capsules, USP, 250 mg, because the drug is subpotent.

    Product
    Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3561-15 UPC 3-3-0591356115-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0109-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Paraben Water for Injection Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Paraben water for injection because quality control observations during an FDA inspection raised concerns about sterility assurance.

    Product
    Paraben water for injection packaged in a sterile 1000 mL clear bottle, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0080-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Fentanyl Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling fentanyl injectable syringes due to quality control issues that may compromise sterility assurance.

    Product
    Fentanyl injectable 2000 mcg/mL packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0138-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Testosterone cypionate 250 mg/mL injections due to quality control issues that may compromise sterility.

    Product
    Testosterone cypionate 250 mg/mL injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0116-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.

    Product
    PGE 20 mcg/mL injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0119-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Phenylephrine Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Phenylephrine 1% injectable vials because quality control issues may compromise sterility assurance.

    Product
    Phenylephrine 1% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0137-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.

    Product
    Tacrolimus oil 0.03% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0057-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Alprostadil Alcohol Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Alprostadil alcohol injectable vials because quality control observations during an FDA inspection presented a risk to sterility assurance.

    Product
    Alprostadil alcohol 500 mcg/mL injectable packaged in amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0047-2015·2014-11-05

    CVS Pain Relieving Antiseptic Spray Recalled for Microbial Contamination

    Wisconsin Pharmacal Company is recalling CVS Pharmacy Pain Relieving Antiseptic Spray because testing revealed microbial growth in the product.

    Product
    CVS pharmacy, Pain Relieving Antiseptic Spray. Benzalkonium Cl 0.13% Lidocaine HCl 2.5% 5 FL OZ (148 mL), OTC, Distributed by CVS Pharmacy, Inc., Woonsocket RI 02895 NDC 68093-6150-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0050-2015·2014-11-05

    Teva Recalls Dextroamphetamine Tablets Due to Unknown Impurities

    Teva Pharmaceuticals is recalling specific lots of dextroamphetamine tablets because they failed impurity specifications. The recall covers 19,545 bottles distributed nationwide.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0106-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Nalbuphine Injection Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Nalbuphine 10 mg/mL injection solution due to quality control observations that present a risk to sterility assurance.

    Product
    Nalbuphine 10 mg/mL injection solution packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0089-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations for Sterility Assurance Concerns

    Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.

    Product
    Hydromorphone/bupivacaine (PF) 0.5 mg/0.2 mg/mL injectable packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V704000·2014-11-05

    Ford Recalls Crown Victoria, Grand Marquis, Town Car for Steering Shaft Defect

    Ford is recalling 2005-2011 Crown Victoria, Grand Marquis, and Town Car vehicles where a prior steering shaft repair may have been incorrect, risking loss of steering control.

    Product
    LINCOLN — LINCOLN, FORD, MERCURY TOWN CAR, CROWN VICTORIA, GRAND MARQUIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0130-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Quad Mix Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Quad Mix injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Quad mix, 9 mg/1 mg/10 mcg/0.1 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0120-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Phenylephrine 10% Ophthalmic Solution

    Martin Avenue Pharmacy is voluntarily recalling Phenylephrine 10% ophthalmic solution due to quality control issues that risk sterility assurance.

    Product
    Phenylephrine 10% opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0048-2015·2014-11-05

    Hi-Tech Pharmacal Recalls HydrOXYzine Hydrochloride Oral Solution Due to Impurity

    Hi-Tech Pharmacal Co., Inc. is recalling 451,916 bottles of HydrOXYzine Hydrochloride Oral Solution because an unknown impurity exceeded specifications during stability testing.

    Product
    HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC 10702
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0123-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Polyhexamethylene biguanide 2% stock solution, due to quality control issues affecting sterility assurance.

    Product
    Polyhexamethylene biguanide 2% stock solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0075-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Compounded Sterile Preparations Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including cyclosporine/corn oil, due to quality control observations that risk sterility assurance.

    Product
    Cyclosporine/corn oil stock vehicle oil packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0157-2015·2014-11-05

    Martin Avenue Pharmacy Recalls Tri-mix ST5 Injectable Due to Sterility Concerns

    Martin Avenue Pharmacy is voluntarily recalling Tri-mix ST5 injectable vials due to quality control observations that present a risk to sterility assurance.

    Product
    Tri-mix ST5, 30 mg/1.5 mg/300 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.
    Category
    Drug
    Distribution
    Distributed nationwide

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