The Recall Desk

Archive

January 2014 recalls

1,423 recalls were announced in January 2014.

What the numbers show

Critical
159
Severe
434
High
277
Moderate
532
Low
21

Of the 1,423 recalls this month scored against our rubric, 11% are Critical, 30% are Severe.

501–600 of 1423

  • SevereFDA (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
  • SevereFDA (Food)·F-1388-2014·2014-01-22

    Jensen's Recalls Hot Smoked Black Cod Due to Botulism Risk

    Jensen's Old Fashioned Smokehouse is recalling Hot Smoked Black Cod sold in Washington because it may lack 'KEEP FROZEN' labels and could be contaminated with Clostridium botulinum.

    Product
    Low salt, vacuum packaged, Hot Smoked Black Cod sold under Clippership. No label was provided.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1408-2014·2014-01-22

    Big Blue Fisheries Recalls Smoked King Salmon Due to Botulism Risk

    Big Blue Fisheries is recalling all smoked products because they may not have been properly cooked, posing a risk of Clostridium botulinum contamination.

    Product
    Teriyaki Smoked King Salmon is sold in vacuum packed plastic packages, net weight from 0.5 to 1 lb., with label located on the front that include the pack date and AK 604. The label is read in parts: "***BIG BLUE FISHERIES, LLC***Teriyaki Smoked King Salmon***Ingredients…
    Category
    Food
    Distribution
    Distributed nationwide
  • 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-735-2014·2014-01-22

    Hyoscyamine Sulfate Tablets Recalled for Potential Label Mixup

    Aidapak Services is recalling Hyoscyamine Sulfate tablets because they may be mislabeled as Azathioprine or Cholecalciferol.

    Product
    HYOSCYAMINE SULFATE SL Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 76439030910
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-435-2014·2014-01-22

    Neomycin Sulfate Ophthalmic Solution Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Neomycin Sulfate ophthalmic solution because sterility cannot be assured after a related product was found non-sterile.

    Product
    Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-474-2014·2014-01-22

    Calcium Citrate Tablets Recalled for Potential Lithium Carbonate Labeling Error

    Aidapak Services is recalling Calcium Citrate tablets that may be mislabeled as Lithium Carbonate ER. The error could lead to incorrect medication administration.

    Product
    CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
    Category
    Drug
    Distribution
    4 states
  • 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 (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-620-2014·2014-01-22

    FDA Recalls Tizanidine Tablets Due to Potential Labeling Error

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

    Product
    tiZANidine HCl Tablet, 1 mg (1/2 of 2 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 55111017915
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-653-2014·2014-01-22

    Aidapak Recalls Vitamin B Complex Tablets Due to Labeling Mixup

    Aidapak Services, LLC is recalling Vitamin B Complex with C/Folic Acid tablets because they may be mislabeled as other prescription or over-the-counter medications.

    Product
    VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258016001
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-425-2014·2014-01-22

    Hyaluronidase Recalled Due to Lack of Assurance of Sterility

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

    Product
    Hyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-447-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Hydroxyprogesterone Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Hydroxyprogesterone 17alpha-PF 250 mg/mL injectable because sterility cannot be assured after a related product was found non-sterile.

    Product
    HYDROXYPROGEST*-17ALPHA -PF 250 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-526-2014·2014-01-22

    FDA Recalls Mislabeled HydrALAZINE Tablets Due to Label Mixup

    Aidapak Services is recalling HydrALAZINE HCl tablets because they may be mislabeled as other prescription drugs. The recall covers repacked drugs distributed in four western states.

    Product
    hydrALAZINE HCl Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155000401
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (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
  • SevereFDA (Drugs)·D-457-2014·2014-01-22

    Calcium Chloride Injection Recalled Due to Sterility Assurance Concerns

    Specialty Medicine Compounding Pharmacy is recalling Calcium Chloride PF 500 mg/mL prefilled syringes because sterility cannot be assured after a related product was found non-sterile.

    Product
    Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1399-2014·2014-01-22

    Jensen's Recalls Hot Smoked Salmon Due to Botulism Risk

    Jensen's Old Fashioned Smokehouse is recalling Jack's Fish Spot Hot Smoked Cajun Atlantic Salmon because it may lack 'KEEP FROZEN' labeling, posing a risk of Clostridium botulinum contamination.

    Product
    Jack's Fish Spot Hot Smoked Cajun Atlantic is a low salt, vacuum packaged, Hot Smoked Salmon. This product is labeled in parts: "***Hot Smoked Atlantic Salmon*** INGREDIENTS: Atlantic Salmon, Salt, Brown Sugar, Spices and Natural Wood Smoke***Important: Keep Frozen. Thaw…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-632-2014·2014-01-22

    FDA Recalls Pimozide Tablets Due to Potential Metoprolol Labeling Error

    Aidapak Services is recalling Pimozide 1 mg tablets that may be mislabeled as Metoprolol Tartrate 12.5 mg. The error poses a risk of incorrect medication administration.

    Product
    PIMOZIDE Tablet, 1 mg (1/2 of 2 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 57844018701
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (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
  • SevereFDA (Food)·F-2011-2014·2014-01-22

    Big Blue Fisheries Recalls Smoked Coho Salmon Due to Botulism Risk

    Big Blue Fisheries is recalling all smoked products because they may not have been properly cooked, posing a risk of Clostridium botulinum contamination.

    Product
    Hickory Smoked Coho Salmon is sold in vacuum packed plastic packages, net weight from 0.5 to 1 lb., with label located on the front that include the pack date and AK 604. The label is read in parts: "***BIG BLUE FISHERIES, LLC***Hickory Smoked Coho Salmon***Ingredients: Wild…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-444-2014·2014-01-22

    Sodium Phosphate Injectable Recalled Due to Sterility Concerns

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

    Product
    SODIUM PHOSPHATE* PF 3MMOL/mL INJECTABLE, SODIUM PHOSPHATE* PF(15 mL) 3MMOL/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-446-2014·2014-01-22

    Sodium Thiosulfate Injectable Recalled for Lack of Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling Sodium Thiosulfate PF, 10% injectable, because sterility cannot be assured after another product was found non-sterile in the same environment.

    Product
    Sodium Thiosulfate PF, 10 % injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-484-2014·2014-01-22

    FDA Recalls Glucosamine/Chondroitin Tablets Due to Potential Label Mixup

    Aidapak Services is recalling Glucosamine/Chondroitin DS tablets because they may be mislabeled as Docusate Sodium capsules. The error could lead to patients taking the wrong medication.

    Product
    GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904559293
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-1390-2014·2014-01-22

    Jensen's Recalls Hot Smoked Sturgeon Due to Botulism Risk

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

    Product
    Low salt, vacuum packaged, Hot Smoked Sturgeon Clippership product is labeled in parts: "***Keep Frozen. Thaw under refrigeration immediately before use***".
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-456-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls WB-Tranexamic Acid Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling WB-Tranexamic acid products because sterility cannot be assured after a related product was found to be non-sterile.

    Product
    WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) TOPICAL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-460-2014·2014-01-22

    Sodium Hydroxide Solution Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Sodium Hydroxide 10% Solution because sterility cannot be assured after a related product was found non-sterile.

    Product
    SODIUM HYDROXIDE (BAC.STATIC) 10% SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • 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 (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
  • 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 (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 (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-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 (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-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 (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-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
  • 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 (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 (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…
    Category
    Food
    Distribution
    1 state
  • 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-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…
    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-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…
    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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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 (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¿…
    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 (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 (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-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-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 (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…
    Category
    Medical Device
    Distribution
    2 states
  • 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…
    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 (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…
    Category
    Food
    Distribution
    1 state
  • 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 (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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-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…
    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
  • 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 (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 (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-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 (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-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 (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
  • 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-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…
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-648-2014·2014-01-22

    Sulfasalazine Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Sulfasalazine 500 mg tablets because they may be mislabeled as Hyoscyamine Sulfate 0.125 mg.

    Product
    sulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762500001
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0768-2014·2014-01-22

    Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Issues

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

    Product
    MCA7-2SB - 2MM Fluted Ball, 7.3CM. 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-488-2014·2014-01-22

    Aidapak Recalls Cholecalciferol Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 2,998 tablets of Cholecalciferol 2000 units because they may be mislabeled as other medications.

    Product
    CHOLECALCIFEROL, Tablet, 2000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904615760
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-406-2014·2014-01-22

    Betachem Recalls Metformin Hydrochloride API Due to CGMP Deviations

    Betachem, Inc. is recalling 27,000 kilos of Metformin Hydrochloride USP active pharmaceutical ingredient because it was not manufactured according to current good manufacturing practices.

    Product
    Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 kg drum, Rx only, Manufactured by: Smruthi Organics Limited, Plot No.: A-27 M.I.D.C., Chincholi, Taq.: Mohol, Solapur-413 255. Maharashtra, India; NDC No.…
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0734-2014·2014-01-22

    Remel Recalls Oxoid Antimicrobial Susceptibility Testing Discs Due to Impregnation Defect

    Remel Inc is recalling Oxoid Antimicrobial Susceptibility Testing Discs because individual discs may not be sufficiently impregnated with antibiotic, resulting in smaller than expected zone sizes.

    Product
    Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 50 discs per cartridge. Firm name on the label is Oxoid, Ltd., Basingstoke, United Kingdom. Used in the semi-quantitative agar diffusion…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0715-2014·2014-01-22

    Anspach MCA Cutting Burr Recalled for Inadequate Labeling Instructions

    The Anspach Effort, Inc. is recalling MCA Cutting Burs because the current directions for use do not provide sufficient details regarding the intended use for these specific burs.

    Product
    Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-523-2014·2014-01-22

    Sertraline HCL Tablets Recalled for Potential Labeling Errors

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

    Product
    SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-554-2014·2014-01-22

    FDA Recalls Fexofenadine Tablets Due to Potential Labeling Error

    Aidapak Services is recalling Fexofenadine HCL 180 mg tablets because they may be mislabeled as Multivitamin/Multimineral tablets.

    Product
    FEXOFENADINE HCL, Tablet 180 mg, Rx only, Distributed by: AidaPak Service, LLC,NDC 41167412003
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-679-2014·2014-01-22

    Aidapak Recalls Mislabeled Atenolol Tablets Due to Labeling Error

    Aidapak Services, LLC is recalling Atenolol tablets that may be mislabeled as Vitamin B Complex or Piroxicam. The error involves specific pedigree codes and expiration dates.

    Product
    ATENOLOL Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 63304062101
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-531-2014·2014-01-22

    FDA Recalls Propranolol HCL Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Propranolol HCL 10 mg tablets because they may be mislabeled as Lactobacillus Acidophilus capsules.

    Product
    PROPRANOLOL HCL Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011010
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-574-2014·2014-01-22

    Galantamine HBR ER Capsules Recalled for Potential Labeling Error

    Aidapak Services is recalling Galantamine HBR ER capsules due to a potential label mixup with Escitalopram tablets.

    Product
    GALANTAMINE HBR ER Capsule, 24 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47335083783
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-709-2014·2014-01-22

    Aidapak Multivitamin Tablets Recalled for Potential Prenatal Label Mixup

    Aidapak Services is recalling Multivitamin/Multimineral Tablets due to a labeling error where they may be mislabeled as Prenatal Multivitamin/Multimineral Tablets.

    Product
    MULTIVITAMIN/MULTIMINERAL Tablet, Distributed by: AidaPak Service, LLC, NDC 65162066810
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-571-2014·2014-01-22

    Desipramine HCL Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Desipramine HCL tablets that may be mislabeled as clomipramine HCl capsules due to a label mixup.

    Product
    DESIPRAMINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 45963034302
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-710-2014·2014-01-22

    Multivitamin Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Multivitamin/Multimineral tablets that may be mislabeled as Omega-3 or Guaifenesin products.

    Product
    MULTIVITAMIN/MULTIMINERAL Tablet, Distributed by: AidaPak Service, LLC, NDC 65162066850
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0731-2014·2014-01-22

    GE Centricity PACS System Recalled for Potential Image Loss During Transfer

    GE Healthcare is recalling Centricity PACS System versions 3.X and 4.X due to a potential loss of diagnostic images during transfers between servers.

    Product
    Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-718-2014·2014-01-22

    Aidapak Recalls Phenobarbital Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling Phenobarbital/Hyoscyamine/Atropine/Scopolamine tablets because they may be mislabeled as Valsartan. The repacked drugs were distributed in four western states.

    Product
    PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 66213042510
    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-539-2014·2014-01-22

    Aidapak Recalls Phytonadione Tablets Due to Potential Labeling Errors

    Aidapak Services is recalling Phytonadione 5 mg tablets because they may be mislabeled as other prescription drugs. The affected 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 (Devices)·Z-0717-2014·2014-01-22

    Leica Biosystems Recalls BOND Polymer Refine Red Detection Due to Fungal Contamination

    Leica Biosystems is recalling BOND Polymer Refine Red Detection kits because they may contain fungal contaminants that can cause staining sensitivity loss or fluid delivery obstructions.

    Product
    Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leica Biosystems Newcastle Ltd; Balliol Business Park West; Benton Lane; Newcastle Upon Tyne NE12 8EW; United Kingdom; www.LeicaBiosystems.com; Bond Polymer Refine Red Detection is a biotin-free, polymeric…
    Category
    Medical Device
    Distribution
    40 states

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