The Recall Desk

Archive

January 2014 recalls

1,423 recalls were announced in January 2014.

What the numbers show

Critical
161
Severe
415
High
291
Moderate
533
Low
23

Of the 1,423 recalls this month scored against our rubric, 11% are Critical, 29% are Severe.

501–600 of 1423

  • SevereFDA (Drugs)·D-619-2014·2014-01-22

    Aidapak Recalls Olanzapine Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Olanzapine 7.5 mg tablets because they may be mislabeled as Levothyroxine or Mirtazapine. The repacked drugs were distributed in four western states.

    Product
    OLANZapine Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55111016530
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-455-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls VIGAMOX Syringes Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling 204 doses of VIGAMOX (moxifloxacin) syringes because sterility cannot be assured after another product was found non-sterile.

    Product
    VIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 mL PREF SYRINGE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-721-2014·2014-01-22

    Aidapak Recalls Docusate Sodium Capsules Due to Labeling Mixup

    Aidapak Services, LLC is recalling Docusate Sodium capsules because they may be mislabeled as other medications. The affected products were distributed in four western states.

    Product
    DOCUSATE SODIUM, Capsule, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 67618010060
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-415-2014·2014-01-22

    Cyanocobalamin Injectable Recalled Due to Sterility Assurance Concerns

    Specialty Medicine Compounding Pharmacy is recalling cyanocobalamin injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    Cyanocobalamin, 1000 mcg/ml; injectable, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-521-2014·2014-01-22

    Pramipexole Tablets Recalled for Potential Label Mixup with Tacrolimus

    Aidapak Services is recalling Pramipexole tablets that may be mislabeled as Tacrolimus capsules. The error could lead to patients taking the wrong medication.

    Product
    PRAMIPEXOLE DI-HCL Tablet, 0.25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714058501
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-672-2014·2014-01-22

    Pantoprazole Sodium Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Pantoprazole Sodium 20 mg tablets because they may be mislabeled as Dronedarone HCL 400 mg.

    Product
    PANTOPRAZOLE SODIUM DR Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175018046
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-416-2014·2014-01-22

    Cyclopentolate HCL Ophthalmic Recall Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Cyclopentolate HCL ophthalmic products because sterility cannot be assured after a related product was found non-sterile.

    Product
    CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-609-2014·2014-01-22

    FDA Recalls Hydrocodone/Acetaminophen Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Hydrocodone Bitartrate/Acetaminophen tablets because they may be mislabeled as Melatonin. The recall covers repacked drugs distributed in four western states.

    Product
    HYDROcodone BITARTRATE/ ACETAMINOPHEN Tablet, 7.5 mg/325 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52544016201
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-510-2014·2014-01-22

    Aidapak Recalls Mislabeled Pantoprazole Sodium Tablets

    Aidapak Services, LLC is recalling 20 mg pantoprazole sodium tablets that may be mislabeled as nortriptyline hydrochloride capsules.

    Product
    PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13668009690
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-440-2014·2014-01-22

    Polidocanol Injectable Recalled Due to Lack of Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling Polidocanol 3% injectable because sterility cannot be assured after a related product was found non-sterile.

    Product
    Polidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-423-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Glutathione PF Inhalation Solution

    Specialty Medicine Compounding Pharmacy is recalling Glutathione PF inhalation solution because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-427-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Hydroxocobalamin/Thiamine Injectable

    Specialty Medicine Compounding Pharmacy is recalling Hydroxocobalamin/Thiamine Injectable due to lack of assurance of sterility. The product was distributed to healthcare providers in Michigan.

    Product
    HYDROXOCOBALAMIN/THIAMINE* 1 mg/100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1398-2014·2014-01-22

    Jensen's Recalls Hot Smoked Salmon Due to Botulism Risk

    Jensen's Old Fashioned Smokehouse is recalling Jack's Fish Spot Hot Smoked Atlantic Garlic & Pepper Chunks because the product may lack 'KEEP FROZEN' labeling and could be contaminated with Clostridium botulinum.

    Product
    Jack's Fish Spot Hot Smoked Atlantic Garlic & Pepper Chunks is a low salt, vacuum packaged, hot smoked salmon. The product is labeled in parts: "***Hot Smoked Atlantic Salmon*** INGREDIENTS: Atlantic Salmon, Salt, Brown Sugar, Spices and Natural Wood Smoke***Important: Keep
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-448-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Quad Mix Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Quad Mix injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    QUAD MIX* IN NACL (1.8/0.2/0.02)mg/18 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-451-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling all unexpired sterile compounded human and veterinary products because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-438-2014·2014-01-22

    Phenol Injectable Recalled Due to Lack of Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling Phenol, 6%, Injectable, because sterility cannot be assured after a related product was found non-sterile.

    Product
    Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-434-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Naltrexone MDV Injectable

    Specialty Medicine Compounding Pharmacy is recalling Naltrexone MDV 1mg/mL injectable because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-428-2014·2014-01-22

    Lidocaine/Sodium Chloride Injectable Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Lidocaine/Sodium Chloride injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    LIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-482-2014·2014-01-22

    Aidapak Recalls Multivitamin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling multivitamin tablets that may be mislabeled as lisinopril. The error could lead to patients taking the wrong medication.

    Product
    MULTIVITAMIN/MULTIMINERAL, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904549213
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-529-2014·2014-01-22

    FDA Recalls Mislabeling of Propranolol HCL Tablets

    Aidapak Services is recalling 2,299 Propranolol HCL 10 mg tablets due to potential mislabeling as other medications.

    Product
    PROPRANOLOL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011001
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-711-2014·2014-01-22

    Aidapak Recalls Guanfacine Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling guanfacine HCl tablets because they may be mislabeled as other prescription medications.

    Product
    guanFACINE HCl Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162071310
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-494-2014·2014-01-22

    FDA Recalls Melatonin Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling 1 mg melatonin tablets that may be mislabeled as quetiapine fumarate or docusate sodium.

    Product
    MELATONIN, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 04746900466
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-568-2014·2014-01-22

    FDA Recalls Fexofenadine Tablets Due to Potential Labeling Mixup

    Aidapak Services is recalling Fexofenadine HCl tablets that may be mislabeled as Pyridoxine, Niacin, or Cranberry Extract.

    Product
    FEXOFENADINE HCl Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802042578
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-569-2014·2014-01-22

    Aidapak Recalls GuaiFENesin ER Tablets Due to Label Mixup

    Aidapak Services, LLC is recalling guaiFENesin ER tablets because they may be mislabeled as fenofibrate or glyburide. The error poses a risk of patients taking the wrong medication.

    Product
    guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802049878
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Food)·F-1404-2014·2014-01-22

    Concertos In Chocolate Recalls Solid Milk Chocolate Santa Candy

    Concertos In Chocolate LLC is recalling Solid Milk Chocolate Santa candy because it is incorrectly labeled and contains an undeclared milk allergen.

    Product
    SOLID MILK CHOCOLATE SANTA candy
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1387-2014·2014-01-22

    Jensen's Recalls Hot Smoked Salmon Due to Labeling and Botulism Risk

    Jensen's Old Fashioned Smokehouse is recalling hot smoked salmon because inconsistent 'KEEP FROZEN' labeling creates a potential risk of Clostridium botulinum contamination.

    Product
    Low salt, vacuum packaged, Hot Smoked Farmed Raised Salmon (Atlantic, Coho, Keta, King, Steelhead, and Sockeye). AKS (Alaska King Seafoods) products such as Sockeye Traditional, Coho Traditional, Keta Traditional, Farmed Atlantic Traditional are labeled in parts: "***IMPORTAN
    Category
    Food
    Distribution
    1 state
  • HighCPSC·14084·2014-01-22

    Playtex Recalls Pacifier Holder Clips Due to Choking Hazard

    Playtex is recalling pacifier holder clips because they can crack and break off small parts, posing a choking hazard to small children.

    Product
    Playtex pacifier holder clips
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1424-2014·2014-01-22

    Whole Foods Recalls Artichoke Wheatberry Salad for E. coli Risk

    Whole Foods Market is recalling Artichoke Wheatberry Salad in Northern California because ingredients are under recall for potential E. coli O157:H7.

    Product
    Artichoke Wheatberry Salad: sold in prepackaged pint and half pint containers in the Prepared Foods Dept. as well as sold fresh from the Deli case and salad bar.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-671-2014·2014-01-22

    Aidapak Recalls Isosorbide Mononitrate Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Isosorbide Mononitrate ER tablets because they may be mislabeled as other prescription drugs.

    Product
    ISOSORBIDE MONONITRATE ER Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175012837
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0729-2014·2014-01-22

    Anspach Carbide Cutting Burrs Recalled Due to Fracture During Use

    The Anspach Effort, Inc. is recalling specific carbide cutting burrs because some fractured during use. The recall covers 28,562 units distributed worldwide.

    Product
    Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0736-2014·2014-01-22

    Atrium Ocean Water Seal Chest Drain tubing may leak or disconnect

    Atrium Medical Corporation is recalling 624 units of Ocean Water Seal Chest Drain ATS Blood Recovery Systems because the tubing may leak or disconnect.

    Product
    Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Code: 2050-070. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0718-2014·2014-01-22

    Anspach Bone Cutting Burs Recalled for Potential Sterile Barrier Breach

    The Anspach Effort, Inc. is recalling single-use sterile bone cutting burs and irrigation clips due to observed layer separation that may compromise the sterile barrier.

    Product
    Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14085·2014-01-22

    Nationwide Trident Pool Gate Latches Recalled for Magnet Failure

    Nationwide Industries is recalling Trident Pool Gate Latches because the magnet can come loose, preventing the gate from securing. No injuries were reported.

    Product
    Nationwide Industries Trident Pool Gate Latches
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1417-2014·2014-01-22

    Fosforel Herring Fillets Recalled Due to Listeria monocytogenes Presence

    Zip International Group LLC is recalling Fosforel Atlantika Herring Fillets in Oil after Listeria monocytogenes was detected in samples.

    Product
    Fosforel Atlantika Herring Fillet in Oil (200 g) Product of Russia Imported by: Zip International Group LLC 160 Raritan Center Parkway, Unit 6 Edison, NJ 08837 UPC: 4607106577526
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0728-2014·2014-01-22

    Anspach Carbide Cutting Burrs Recalled Due to Fracture During Use

    The Anspach Effort, Inc. is recalling carbide cutting burrs and drums because some fractured during use. The products are used for cutting and shaping bone.

    Product
    Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15DRMC Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-639-2014·2014-01-22

    Aripiprazole Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Aripiprazole 2 mg tablets because they may be mislabeled as other prescription drugs.

    Product
    ARIPiprazole Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59148000613
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0742-2014·2014-01-22

    Atrium Express Dry Seal ATS Chest Drain Recalled for Leak or Disconnect Risk

    Atrium Medical Corporation is recalling 7,274 units of the Express Dry Seal ATS Chest Drain because the tubing may leak or disconnect.

    Product
    Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0739-2014·2014-01-22

    Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System Recall

    Atrium Medical Corporation is recalling 1,002 units of Ocean Water Seal Chest Drain ATS Blood Recovery Systems due to potential tubing leaks or disconnections.

    Product
    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-300. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0771-2014·2014-01-22

    Teleflex Recalls Electrosurgical Coagulation Suction Tubes Due to Sterility Concerns

    Teleflex Medical is recalling 17,450 electrosurgical coagulation suction tubes because sterility cannot be guaranteed. The devices are distributed nationwide.

    Product
    Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 27709. Intended to remove tissue and control bleeding by use of high-frequency electrical current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0710-2014·2014-01-22

    Boston Scientific Recalls Extractor Pro XL Retrieval Balloon Catheters

    Boston Scientific is recalling 39 units of Extractor Pro XL Retrieval Balloon Catheters due to potential incorrect skive hole location or balloon size.

    Product
    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while occludin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0720-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity Issues

    Boston Scientific is recalling 425 TWISTER PLUS 22mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign bod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-550-2014·2014-01-22

    Nicotine Polacrilex Lozenges Recalled for Potential Label Mixup

    Aidapak Services is recalling 1,582 Nicotine Polacrilex Lozenges because they may be mislabeled as other prescription drugs.

    Product
    NICOTINE POLACRILEX Lozenge, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 37205098769
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0711-2014·2014-01-22

    Boston Scientific Recalls Extractor Pro XL Retrieval Balloon Catheters

    Boston Scientific is recalling 38 units of Extractor Pro XL Retrieval Balloon Catheters due to potential defects in skive hole location or balloon size.

    Product
    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-508-2014·2014-01-22

    Aidapak Recalls Labeled LamoTRIgine Tablets Due to Potential Label Mixup

    Aidapak Services is recalling lamoTRIgine tablets that may be mislabeled as oxybutynin chloride or fexofenadine HCL. The error could lead to patients taking the wrong medication.

    Product
    lamoTRIgine, Tablet, 50 mg (1/2 of 100 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 13668004701
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-462-2014·2014-01-22

    NorthStar Arthritis Relief Cream Recalled for Microbial Contamination

    Mariposa Labs is recalling NorthStar Arthritis Relief Cream because the product failed microbiological specifications.

    Product
    NorthStar Arthritis Relief Cream. Net Wt. 2 oz tube, OTC, Manufactured for and Distributed by NewMarket Health Products, LLC. 702 Cathedral St. Baltimore, MD 21201
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-408-2014·2014-01-22

    Lupin Recalls Quinapril Tablets Due to Unknown Impurity

    Lupin Pharmaceuticals is recalling Quinapril tablets because an unknown impurity exceeded specification limits during stability testing.

    Product
    QUINAPRIL — QUINAPRIL (QUINAPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-557-2014·2014-01-22

    Liothyronine Sodium Tablets Recalled for Potential Labeling Errors

    Aidapak Services is recalling Liothyronine Sodium 25 mcg tablets because they may be mislabeled as Guanfacine or Bromocriptine.

    Product
    LIOTHYRONINE SODIUM, Tablet 25 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 42794001902
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-518-2014·2014-01-22

    FDA Recalls Famotidine Tablets Due to Potential Labeling Errors

    Aidapak Services is recalling 700-tablet bottles of 20 mg Famotidine tablets because they may be mislabeled as other medications.

    Product
    FAMOTIDINE Tablet, 20 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 16714036104
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0772-2014·2014-01-22

    Becton Dickinson Recalls BD Interlink Threaded Lock Cannula Due to Seal Defects

    Becton Dickinson is recalling BD Interlink Threaded Lock Cannulas because some units may have open seals, compromising sterility.

    Product
    BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink¿ injection site. It is screwed down over the Interlink¿ injection site and a blunt plastic cannula inside the housing enters the Interlink¿ injectio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1386-2014·2014-01-22

    Colony Brands Recalls Lobster Bisque Due to Undeclared Wheat Allergen

    Colony Brands is recalling 19 units of Lobster Bisque because the product contains undeclared wheat. The recall affects specific lots distributed across 12 states.

    Product
    Lobster Bisque, product 45036. Net WT 4.0 lbs. Keep Frozen.
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1425-2014·2014-01-22

    Whole Foods Southwest Salad Recalled for Potential E. coli Contamination

    Whole Foods Market is recalling Southwest SooFoo Salad in Northern California due to potential E. coli O157:H7 contamination in ingredients.

    Product
    Southwest SooFoo Salad: sold in prepackaged pint and half pint containers in the Prepared Foods Dept. as well as sold fresh from the Deli case and salad bar.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1418-2014·2014-01-22

    Glass Onion Catering Recalls Greek Style Orzo Salad Due to E. coli

    Atherstone Foods Inc dba Glass Onion Catering is recalling Delish Greek Style Orzo Salad because an investigation linked the supplier to an E. coli O157:H7 outbreak.

    Product
    Delish Greek Style Orzo Salad; Traditional orzo, cucumber, red bell peppers, green onion and Kalamata olives tossed with a creamy Greek Style yogurt and feta dressing. 6 oz (170g) in clam shell plastic container. Packaged for Walgreens Manufactured by Glass Onion Catering,
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0727-2014·2014-01-22

    Anspach Carbide Cutting Burrs Recalled Due to Fracture During Use

    The Anspach Effort, Inc. is recalling specific carbide cutting burrs because some fractured during use. The devices are intended for cutting and shaping bone.

    Product
    Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide Flut
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0722-2014·2014-01-22

    Boston Scientific Recalls Twister Plus Retrieval Devices Due to Seal Integrity Issues

    Boston Scientific is recalling 253 Twister Plus 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a retrieva
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0779-2014·2014-01-22

    Anspach MIA 16 Minimally Invasive Attachment Recalled for Sterility Failure

    The Anspach Effort, Inc. is recalling 183 Anspach MIA 16 attachments because they did not reach the expected sterility assurance level.

    Product
    Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-691-2014·2014-01-22

    Zolpidem Tartrate Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Zolpidem Tartrate tablets that may be mislabeled as Temazepam capsules due to a label mixup.

    Product
    ZOLPIDEM TARTRATE, Tablet, 2.5 mg (1/2 of 5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 64679071401
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-642-2014·2014-01-22

    Methylprednisolone Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling methylprednisolone tablets that may be mislabeled as levothyroxine sodium due to a labeling mixup.

    Product
    methylPREDNISolone Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59746000103
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0733-2014·2014-01-22

    Vital Diagnostics Recalls Eon Calcium Reagent Due to High Positive Bias

    Vital Diagnostics, Inc. is recalling 213 units of Eon Calcium Reagent because high positive calcium bias was observed in plasma samples compared to serum results.

    Product
    Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0770-2014·2014-01-22

    Teleflex Recalls Electrosurgical Suction Tubes Due to Sterility Concerns

    Teleflex Medical is recalling 17,450 electrosurgical coagulation suction tubes because sterility cannot be guaranteed. The devices were distributed nationwide.

    Product
    Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 2770. Intended to remove tissue and control bleeding by use of high-frequency electrical current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0741-2014·2014-01-22

    Atrium Oasis Chest Drain Tubing Recalled for Leak or Disconnect Risk

    Atrium Medical Corporation is recalling 954 units of Oasis Dry Suction Water Seal ATS Chest Drains because the tubing may leak or disconnect.

    Product
    Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Product Code: 3652-100. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity

    Boston Scientific is recalling TWISTER PLUS 22mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a retrieval d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0747-2014·2014-01-22

    GE Healthcare Carescape Patient Data Module Recall for Latch Failure

    GE Healthcare is recalling Carescape Patient Data Modules due to a potential safety issue involving the intermittent failure of the spring-loaded mounting latch.

    Product
    GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-412-2014·2014-01-22

    FDA Recalls Bevacizumab Due to Lack of Assurance of Sterility

    Specialty Medicine Compounding Pharmacy is recalling repackaged Bevacizumab because sterility cannot be assured. The recall affects 2,801 doses distributed in Michigan.

    Product
    Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0724-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity

    Boston Scientific is recalling 3,300 TWISTER PLUS 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. Universal Product Number (UPN):M00561422 Distributed by: Boston Scientific, Nat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0738-2014·2014-01-22

    Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System Recalled

    Atrium Medical Corporation is recalling 361 units of the Ocean Water Seal Chest Drain ATS Blood Recovery System because the tubing may leak or disconnect.

    Product
    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors Product Code: 2052-000. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0740-2014·2014-01-22

    Atrium Oasis Chest Drain Tubing Recalled for Leak or Disconnect Risk

    Atrium Medical Corporation is recalling Oasis Dry Suction Water Seal ATS Chest Drains because the tubing may leak or disconnect.

    Product
    Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0709-2014·2014-01-22

    King Systems Recalls Supraglottic Airway Kits Due to Incorrect Component

    King Systems Corp. is recalling King LTSD Kit Size 4 supraglottic airway devices because some packages contained KLTD214 airways that lack a required gastric suction tube lumen.

    Product
    King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway Identification Part Number(s): KLTSD414 KING LTSD KIT/KIT/TROUSSE/KIT SIZE 4 Contents: 1 - KLTSD Size 4......(155 - 180cm) .. 1 - 60cc Syringe 1 - Sterile Lubri
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0735-2014·2014-01-22

    Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System Recall

    Atrium Medical Corporation is recalling Ocean Water Seal Chest Drain ATS Blood Recovery Systems because the tubing may leak or disconnect.

    Product
    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0719-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity Issues

    Boston Scientific is recalling TWISTER PLUS 22mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0748-2014·2014-01-22

    GE Healthcare Recalls Merge Mammo Workstation Software Due to Image Display Errors

    GE Healthcare is recalling 28 units of Merge Mammo software version 8.0.2 because images may display out of sync with the navigator, potentially leading to misdiagnosis.

    Product
    Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices, including digital mammography, ultrasound, MRI and CT.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Food)·F-1394-2014·2014-01-22

    Jensen's Recalls Hot Smoked Pink Salmon for Botulism Risk

    Jensen's Old Fashioned Smokehouse is recalling 20,271 lbs of Hot Smoked Pink Salmon in Washington due to missing 'KEEP FROZEN' labels and potential Clostridium botulinum contamination.

    Product
    Hot Smoked Pink Salmon is Low salt, vacuum packaged. Clippership Hot Smoked Pink Salmon does not have any labels. Lummi Island Co-Op product's label is read in parts: "***WILD SMOKED PINK SALMON***LUMMI ISLANDWILD.COM***KEEP FROZEN***Thawing Instructions: Remove all packag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-465-2014·2014-01-22

    Aidapak Recalls Omega-3 Fatty Acid Capsules Due to Labeling Error

    Aidapak Services, LLC is recalling 2,799 Omega-3 Fatty Acid capsules because they may be mislabeled as Docusate Calcium. The error could lead to patients receiving the wrong medication.

    Product
    OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904404360
    Category
    Drug
    Distribution
    4 states
  • HighCPSC·14083·2014-01-22

    Midwest-CBK Recalls Baby Rattles Due to Choking Hazard

    Midwest-CBK is recalling about 1,900 baby rattles because the head can detach, posing a choking hazard to young children.

    Product
    Baby rattles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-527-2014·2014-01-22

    Leflunomide Tablets Recalled Due to Potential Labeling Mixup

    Aidapak Services is recalling Leflunomide 10 mg tablets because they may be mislabeled as Doxycycline or Sevelamer Carbonate.

    Product
    LEFLUNOMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155004303
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-491-2014·2014-01-22

    Aidapak Recalls Docusate Sodium Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 4,318 Docusate Sodium capsules because they may be mislabeled as other medications. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

    Product
    DOCUSATE SODIUM, Capsule, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904789159
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-645-2014·2014-01-22

    Aidapak Recalls Mirtazapine Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling Mirtazapine 7.5 mg tablets because they may be mislabeled as other prescription medications.

    Product
    MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762141503
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-731-2014·2014-01-22

    FDA Recalls Pramipexole Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Pramipexole Di-HCl tablets that may be mislabeled as Liothyronine Sodium. The error poses a risk of incorrect medication administration.

    Product
    PRAMIPEXOLE DI-HCL, Tablet, 1.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462033490
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Food)·F-1403-2014·2014-01-22

    Bee International Recalls Sweet Spots Candy for Undeclared Egg Allergen

    Bee International is recalling Sweet Spots Candy because it contains an undeclared egg allergen. The affected products were distributed nationwide in the US and Canada.

    Product
    Candy Sweet Spots, 2oz. (3 display packages/case; 12-2oz packages/display case). UPC 0-73563-00471-6
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-636-2014·2014-01-22

    Sevelamer HCl Tablets Recalled for Potential Labeling Error

    Aidapak Services, LLC is recalling Sevelamer HCl tablets that may be mislabeled as Ranolazine ER due to a labeling mixup.

    Product
    SEVELAMER HCl Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 58468002101
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-506-2014·2014-01-22

    FDA Recalls Chlorophyllin Copper Complex Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling Chlorophyllin Copper Complex tablets that may be mislabeled as trazodone hydrochloride.

    Product
    CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 11868000901
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-570-2014·2014-01-22

    Loratadine Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Loratadine 10 mg tablets because they may be mislabeled as Glycopyrrolate or Omega-3 fatty acids.

    Product
    LORATADINE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45802065078
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-483-2014·2014-01-22

    Aidapak Recalls Diphenhydramine Tablets Due to Potential Labeling Mixup

    Aidapak Services is recalling diphenhydramine HCl tablets because they may be mislabeled as atorvastatin, prenatal vitamins, or venlafaxine.

    Product
    diphenhydrAMINE HCl, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904555159
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-480-2014·2014-01-22

    Zinc Sulfate Capsules Recalled for Potential Mislabeling as Sertraline

    Aidapak Services is recalling Zinc Sulfate capsules that may be mislabeled as Sertraline HCL tablets. The error could lead to patients taking the wrong medication.

    Product
    ZINC SULFATE, Capsule, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904533260
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-595-2014·2014-01-22

    Aidapak Recalls Torsemide Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 10 mg Torsemide tablets because they may be mislabeled as 50 mg Pyridoxine HCl tablets.

    Product
    TORSEMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111091601
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-696-2014·2014-01-22

    Aidapak Recalls Colchicine Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling specific lots of Colchicine 0.6 mg tablets because they may be mislabeled as other medications.

    Product
    COLCHICINE Tablet, 0.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764011907
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-684-2014·2014-01-22

    FDA Recalls GuaiFENesin ER Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling GuaiFENesin ER tablets because they may be mislabeled as Omega-3 acid ethyl esters capsules.

    Product
    guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000850
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-708-2014·2014-01-22

    Aidapak Recalls Flecaïnide Tablets Due to Potential Label Mixup

    Aidapak Services is recalling Flecaïnide Acetate tablets that may be mislabeled as Vitamin B Complex with C due to a labeling error.

    Product
    FLECAINIDE ACETATE Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65162064110
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-694-2014·2014-01-22

    Aidapak Recalls Metaxalone Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling Metaxalone 800 mg tablets because they may be mislabeled as Esterified Estrogens 0.625 mg.

    Product
    METAXALONE Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64720032110
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-466-2014·2014-01-22

    Aidapak Recalls Cyanocobalamin Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 1,821 tablets of Cyanocobalamin 1000 mcg due to a potential label mixup with other medications.

    Product
    CYANOCOBALAMIN, Tablet, 1000 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904421713
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-627-2014·2014-01-22

    Aidapak Recalls Tizanidine Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Tizanidine HCL tablets because they may be mislabeled as Nicotine Polacrilex or Nifedipine ER.

    Product
    tiZANidine HCL Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050289
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-661-2014·2014-01-22

    Aidapak Recalls Atorvastatin Calcium Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling Atorvastatin Calcium 20 mg tablets because they may be mislabeled as GuaiFENesin ER 600 mg.

    Product
    ATORVASTATIN CALCIUM Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505257909
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0753-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors

    The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions were unclear.

    Product
    MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-541-2014·2014-01-22

    Aidapak Recalls Phytonadione Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling Phytonadione 5 mg tablets because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.

    Product
    PHYTONADIONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 25010040515
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-733-2014·2014-01-22

    Aidapak Recalls Magnesium Chloride Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Magnesium Chloride tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    MAGNESIUM CHLORIDE, Tablet, 64 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 68585000575
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-681-2014·2014-01-22

    Lurasidone HCl Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Lurasidone HCl 120 mg tablets because they may be mislabeled as Duloxetine HCl DR 20 mg capsules.

    Product
    LURASIDONE HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63402031230
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-616-2014·2014-01-22

    Aidapak Recalls Glucosamine/Chondroitin Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Glucosamine/Chondroitin capsules because they may be mislabeled as Fexofenadine HCL tablets.

    Product
    GLUCOSAMINE/CHONDROITIN Capsule, 500 mg/400 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 54458010022
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-678-2014·2014-01-22

    Aidapak Recalls Metoprolol Tablets Due to Potential Labeling Errors

    Aidapak Services is recalling Metoprolol Tartrate tablets because they may be mislabeled as Pioglitazone or Levothyroxine Sodium.

    Product
    METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 63304057901
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-599-2014·2014-01-22

    Aidapak Recalls Pyridoxine HCL Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Pyridoxine HCL 50 mg tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    PYRIDOXINE HCL Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 51645090901
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-581-2014·2014-01-22

    Lactobacillus GG Capsules Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Lactobillus GG capsules because they may be mislabeled as aspirin, zonisamide, or venlafaxine.

    Product
    LACTOBACILLUS GG Capsule, 15 Billion Cells, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374
    Category
    Drug
    Distribution
    4 states

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