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.

Which agencies issued them

401–500 of 1423

  • SevereFDA (Food)·F-1410-2014·2014-01-22

    Big Blue Fisheries Recalls Smoked Coho Salmon Bellies 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
    Smoked Coho Salmon Bellies 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***Smoked Coho Salmon Bellies***Ingredients: Wild
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-644-2014·2014-01-22

    Aidapak Recalls Nifedipine Capsules Due to Potential Labeling Error

    Aidapak Services is recalling Nifedipine 10 mg capsules because they may be mislabeled as Nitrofurantoin 100 mg. The repacked drugs were distributed in four western states.

    Product
    NIFEdipine Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762100401
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-1391-2014·2014-01-22

    Jensen's Recalls Hot Smoked Salmon for Botulism Risk and Labeling Errors

    Jensen's Old Fashioned Smokehouse is recalling 14,628 lbs of hot smoked salmon in Washington due to potential Clostridium botulinum contamination and missing 'KEEP FROZEN' labels.

    Product
    Low salt, vacuum packaged, Hot Smoked Salmon (may include any of the following varieties Coho, Keta, King, Sockeye). Jensen's product is labeled in part "*** JENSEN'S SEATTLE STYLE SMOKED WILD PACIFIC SALMON JENESN'S SMOKEHOUSE, INC. *** Keep Refrigerated Below 38 F*** INGREDI
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2012-2014·2014-01-22

    Big Blue Fisheries Recalls Pepper Smoked Coho Salmon Due to Botulism Risk

    Big Blue Fisheries is recalling all smoked products, including Pepper Smoked Coho Salmon, because they may not have been properly cooked and could be contaminated with Clostridium botulinum.

    Product
    Pepper 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***Pepper Smoked Coho Salmon***Ingredients: Wild Al
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-608-2014·2014-01-22

    FDA Recalls FIDAXOMICIN Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling FIDAXOMICIN 200 mg tablets that may be mislabeled as BENAZEPRIL HCL 40 mg. The error affects repacked drugs distributed in four western states.

    Product
    FIDAXOMICIN Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 52015008001
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0714-2014·2014-01-22

    Draeger Infinity Acute Care System Recall for Alarm Failure

    Draeger Medical Systems is recalling 439 Infinity Acute Care System units because a high-grade SpO2 alarm may fail to activate after a medium-grade alarm is paused.

    Product
    Draeger Infinity Acute Care System Monitoring Solution
    Category
    Medical Device
    Distribution
    8 states
  • 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 (Devices)·Z-0723-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Issues

    Boston Scientific is recalling 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 5 configuration) Universal Product Number (UPN):M00561421. 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
  • SevereFDA (Food)·F-1419-2014·2014-01-22

    Glass Onion Catering Recalls Asian Style Noodle Salad Due to E. coli Outbreak

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

    Product
    Delish Asian Style Noodle Salad, Tender noodles, crisp snowpeas, carrots and red bell peppers tossed with a zesty sesame dressing. 6 oz (170g) in clam shell plastic container. Packaged for Walgreens Manufactured by Glass Onion Catering, Richmond, CA.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-442-2014·2014-01-22

    Proparacaine HCl Ophthalmic Solution Recalled for Sterility Concerns

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

    Product
    Proparacaine HCl PF, 0.5% ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-419-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Epinephrine Due to Sterility Concerns

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

    Product
    EPINEPHRINE PF SF* (0.3 mL); (1 mL), (0.5 mL IN 3 mL SYRINGE) 1:1000 OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1422-2014·2014-01-22

    Glass Onion Catering Recalls Southwestern Salad Kits Due to E. coli Outbreak

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

    Product
    Southwestern Salad kit (20 lb box). Contents in individual Bags: Cooked Soo Foo Roasted Corn Red and Yellow Bell Peppers Jalapenos Cilantro Pepitas Dressing. Packaged for Whole Foods Manufactured by Glass Onion Catering, Richmond, CA
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-701-2014·2014-01-22

    Aidapak Recalls Cholecalciferol Tablets Due to Potential Labeling Errors

    Aidapak Services, LLC is recalling Cholecalciferol/Calcium/Phosphorus tablets because they may be mislabeled as Promethazine HCl or Valsartan.

    Product
    CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS Tablet, 120 units/105 mg/81 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64980015001
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-1395-2014·2014-01-22

    Jensen's Recalls Hot Smoked Sockeye Salmon for Botulism Risk

    Jensen's Old Fashioned Smokehouse is recalling 3,446 lbs of hot smoked sockeye salmon in Washington due to missing 'KEEP FROZEN' labels and potential Clostridium botulinum contamination.

    Product
    Hot Smoked Alaskan Sockeye Salmon is a low salt, vacuum packaged. Great Ruby Fish Co Sockeye Hot smoked salmon has no labels. ROLF'S Choice Sockeye Salmon is labeled in parts: "***ROLF'S CHOICE***SMOKED ALASKAN SOCKEYE SALMON*** Ingredients: salmon, salt, brown sugar, hard
    Category
    Food
    Distribution
    1 state
  • 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-736-2014·2014-01-22

    Sigma-Tau Recalls Oncaspar Injection Due to Sterility Concerns

    Sigma-Tau Pharmaceuticals is voluntarily recalling five lots of Oncaspar Injection because a crack under the crimp seal caused a leak, compromising sterility.

    Product
    PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-tau PHARMACEUTICALS INC, 9841 Washingtonian Blvd, Gaithersburg, MD 20878 NDC 54482-301-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-596-2014·2014-01-22

    Rivaroxaban Tablets Recalled for Potential Venlafaxine Labeling Error

    Aidapak Services is recalling Rivaroxaban 20 mg tablets that may be mislabeled as Venlafaxine HCL 100 mg due to a label mixup.

    Product
    RIVAROXABAN Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50458057930
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-514-2014·2014-01-22

    Aidapak Recalls Propranolol HCL Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Propranolol HCL 10 mg tablets that may be mislabeled as Pioglitazone HCL 15 mg. The repacked drugs were distributed in four western states.

    Product
    PROPRANOLOL HCL, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714002104
    Category
    Drug
    Distribution
    4 states
  • 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-422-2014·2014-01-22

    Gatifloxacin Ophthalmic Drops Recalled for Lack of Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling repackaged Gatifloxacin ophthalmic drops because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-473-2014·2014-01-22

    FDA Recalls Calcium Citrate Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling calcium citrate tablets that may be mislabeled as trimethobenzamide HCL capsules.

    Product
    CALCIUM CITRATE, Tablet, 950 mg (200 MG ELEMENTAL Ca), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904506260
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-673-2014·2014-01-22

    Aidapak Recalls OXcarbazepine Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling OXcarbazepine 150 mg tablets because they may be mislabeled as traZODone HCl 50 mg.

    Product
    OXcarbazepine Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62756018388
    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-430-2014·2014-01-22

    Methocarbamol Injectable Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Methocarbamol 100 mg/mL injectable because sterility cannot be assured after a related product was found non-sterile.

    Product
    METHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, 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-597-2014·2014-01-22

    FDA Recalls TACROLIMUS Capsules Due to Potential Labeling Error

    Aidapak Services, LLC is recalling TACROLIMUS Capsules, 1 mg, because they may be mislabeled as LEVOTHYROXINE SODIUM Tablets, 125 mcg.

    Product
    TACROLIMUS Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50742020801
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-413-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Ceftazidime Ophthalmic Solution

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

    Product
    Ceftazidime, 22.5 mg/ml (ophthalmic), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • 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
  • SevereFDA (Drugs)·D-452-2014·2014-01-22

    Tropicamide 1% Ophthalmic Solution Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Tropicamide 1% Ophthalmic Solution because sterility cannot be assured after a related product was found non-sterile.

    Product
    TROPICAMIDE* 1% OPHTHALMIC SOLUTION, 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-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-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 (Drugs)·D-437-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Papaverine HCL Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Papaverine HCL injectable because sterility cannot be assured after another product was found non-sterile in the same environment.

    Product
    Papaverine HCL, 30 mg/mL injectable, also labeled as (10 mL) and (2 mL), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-582-2014·2014-01-22

    Aspirin Tablets Recalled for Potential Mislabeling as Cholecalciferol

    Aidapak Services is recalling Aspirin tablets that may be mislabeled as Cholecalciferol. The FDA classifies this as a Class II recall.

    Product
    ASPIRIN Tablet, 325 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49348000123
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-418-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls EDETATE DISODIUM Ophthalmic Solution

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

    Product
    EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, 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-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-445-2014·2014-01-22

    Sodium tetradecyl sulfate recalled due to lack of sterility assurance

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

    Product
    Sodium tetradecyl SO4, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-720-2014·2014-01-22

    Aidapak Recalls Selegiline HCL Capsules Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling Selegiline HCL 5 mg capsules because they may be mislabeled as Itraconazole 100 mg. The repacked drugs were distributed in four western states.

    Product
    SELEGILINE HCL, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 67253070006
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-1423-2014·2014-01-22

    Glass Onion Catering Recalls Wheat Berry Salad Kits Due to E. coli

    Atherstone Foods Inc dba Glass Onion Catering is recalling Wheat Berry Salad kits because an investigation linked the supplier to an E. coli O157:H7 outbreak.

    Product
    Wheat Berry Salad kit (20 lb box). Contents in package: Cooked Wheat Berry Zucchini Cherry Tomatoes Red Bell Pepper Artichoke Pieces Shallots Almonds Dressing. Packaged for Whole Foods Manufactured by Glass Onion Catering, Richmond, CA
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-602-2014·2014-01-22

    Warfarin Sodium Tablets Recalled Due to Potential Label Mixup

    Aidapak Services is recalling Warfarin Sodium 0.5 mg tablets because they may be mislabeled as Sodium Chloride 1 mg tablets.

    Product
    WARFARIN SODIUM Tablet, 0.5 mg (1/2 of 1 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 51672402701
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-431-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

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

    Product
    METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 1000 mcg/mL INJECTABLE, METHYLCOBALAMIN* 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 5000 mcg/mL INJECTABLE, METHYLCOBALAMIN* PF 1000 mcg/mL PREF SYRINGE, Rx only, Specialty Medicine Co
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1406-2014·2014-01-22

    Big Blue Fisheries Recalls Pepper 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
    Pepper Smoked King Salmon. Product 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***Pepper Smoked King Salmon***Ingredients:
    Category
    Food
    Distribution
    Distributed nationwide
  • 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-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-454-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Vancomycin Ophthalmic Solution

    Specialty Medicine Compounding Pharmacy is recalling Vancomycin HCL 10 mg/mL Ophthalmic Solution because sterility cannot be assured. The product was distributed to healthcare providers and patients in Michigan.

    Product
    VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, 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
  • SevereFDA (Drugs)·D-704-2014·2014-01-22

    Sodium Bicarbonate Tablets Recalled for Potential Label Mixup

    Aidapak Services is recalling 1,013 sodium bicarbonate tablets that may be mislabeled as nicotine polacrilex lozenges.

    Product
    SODIUM BICARBONATE Tablet, 650 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64980018210
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0737-2014·2014-01-22

    Atrium Ocean Water Seal Chest Drain ATS Recall for Tubing Leaks

    Atrium Medical Corporation is recalling 6,684 Ocean Water Seal Chest Drain ATS units because the chest drain tubing may leak or disconnect.

    Product
    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-613-2014·2014-01-22

    Mesalamine CR Capsules Recalled for Potential Label Mixup with Aspirin

    Aidapak Services is recalling Mesalamine CR capsules that may be mislabeled as Aspirin EC tablets due to a labeling error.

    Product
    MESALAMINE CR Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 54092018981
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-1397-2014·2014-01-22

    Jensen's Alaska King Salmon Garlic Pepper Hot Smoked Salmon Recall

    Jensen's Old Fashioned Smokehouse is recalling Garlic Pepper Hot Smoked Salmon due to missing 'KEEP FROZEN' labels and potential Clostridium botulinum contamination.

    Product
    Low salt, vacuum packaged, Garlic Pepper Hot Smoked Salmon with Hardwood. AKS (Alaska King Salmon) product is labeled in parts: "***Garlic Pepper Smoked Salmon product ***GARLIC PEPPER SMOKED SALMON ***INGREDIENTS: SALMON, SALT, BROWN SUGAR, GARLIC, PEPPER, HARDWOOD SMOKE***"
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-641-2014·2014-01-22

    FDA Recalls Mislabeled Darunavir Tablets Distributed by Aidapak Services

    Aidapak Services is recalling Darunavir tablets that may be mislabeled as Hydrocodone/Acetaminophen. The error could lead to incorrect medication administration.

    Product
    DARUNAVIR Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59676056630
    Category
    Drug
    Distribution
    4 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-722-2014·2014-01-22

    FDA Recalls Mislabeled bupropion HCl ER Tablets

    Aidapak Services, LLC is recalling bupropion HCl ER tablets that may be mislabeled as mesalamine CR capsules due to a labeling mixup.

    Product
    buPROPion HCl ER (XL), Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 67767014130
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-544-2014·2014-01-22

    Quinapril Tablets Recalled for Potential Mislabeling as Propranolol HCL

    Aidapak Services, LLC is recalling Quinapril 40 mg tablets that may be mislabeled as Propranolol HCL 10 mg. The error involves a label mixup on repacked drugs.

    Product
    QUINAPRIL Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 31722027090
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-1415-2014·2014-01-22

    Big Blue Fisheries Recalls Smoked Black Cod Due to Botulism Risk

    Big Blue Fisheries is recalling all smoked products, including hickory smoked black cod, because they may not have been properly cooked and could be contaminated with Clostridium botulinum.

    Product
    Hickory Smoked Black Cod 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 Black Cod***Ingredients: Wild Alas
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1392-2014·2014-01-22

    Jensen's Recalls Teriyaki Salmon for Missing Frozen Label and Botulism Risk

    Jensen's Old Fashioned Smokehouse is recalling Alaska King Seafoods Short Strips Teriyaki salmon because it lacks a 'KEEP FROZEN' label, creating a potential risk of Clostridium botulinum contamination.

    Product
    Short Strips Teriyaki is a low salt, vacuum packaged, Hot Smoked Salmon, and it is sold under Alaska King Seafoods brand. The labels contain the following statement above or below the product name and/or ingredient statement: "***IMPORTANT KEEP FROZEN***THAW UNDER REFRIGERA
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-600-2014·2014-01-22

    Aidapak Recalls Clomipramine Capsules Due to Potential Labeling Errors

    Aidapak Services is recalling Clomipramine HCl capsules because they may be mislabeled as other prescription medications.

    Product
    clomiPRAMINE HCl Capsule, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 51672401205
    Category
    Drug
    Distribution
    4 states
  • 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 (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-443-2014·2014-01-22

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

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

    Product
    QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/50 mcg INJECTABLE, QUAD MIX* 0.1 mg/9 mg/1 mg/10 mcg/mL INJECTABLE, SUPER QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, (pavaperine HCl, phentolamine, pr
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1409-2014·2014-01-22

    Big Blue Fisheries Recalls Smoked King Salmon Bellies 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
    Smoked King Salmon Bellies 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***Smoked King Salmon Bellies***Ingredients: Wild
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1405-2014·2014-01-22

    North Pacific Seafoods Recalls Sitka Sound Hickory Smoked Salmon

    North Pacific Seafoods is recalling Sitka Sound Seafoods Hickory Smoked Salmon due to potential Clostridium botulinum contamination and lack of thermal processing records.

    Product
    Sitka Sound Seafoods Hickory Smoked Salmon (Coho, King, or Sockeye) is hot smoked salmon, vacuum packaged, random net weight. The product is labeled in parts: "***Sitka Sound Seafoods***329 Katlian St. Sitka, Ak. 99835***Hickory Smoked***Salmon***Ingredients: Wild Alaskan Coh
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-697-2014·2014-01-22

    Aidapak Recalls Lubiprostone Capsules Due to Potential Labeling Errors

    Aidapak Services is recalling Lubiprostone capsules because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.

    Product
    LUBIPROSTONE Capsule, 24 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764024060
    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-453-2014·2014-01-22

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

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

    Product
    TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/mL INJECTABLE (papaverine hydrochloride, phentolamine, prostaglandin), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-426-2014·2014-01-22

    Hydroxocobalamin Injectable Recalled Due to Sterility Assurance Concerns

    Specialty Medicine Compounding Pharmacy is recalling Hydroxocobalamin 10,000 mcg/mL injectable because sterility cannot be assured after a related product was found non-sterile.

    Product
    HYDROXOCOBALAMIN* 10,000 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-714-2014·2014-01-22

    Colesevelam HCL Tablets Recalled for Potential Label Mixup

    Aidapak Services is recalling Colesevelam HCL tablets that may be mislabeled as lamoTRIgine due to a labeling error.

    Product
    COLESEVELAM HCL Tablet, 625 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65597070118
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-615-2014·2014-01-22

    Lanthanum Carbonate Chew Tablets Recalled for Potential Label Mixup

    Aidapak Services is recalling Lanthanum Carbonate Chew Tablets due to a potential label mixup with other medications. The repacked drugs were distributed in four western states.

    Product
    LANTHANUM CARBONATE Chew Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 54092025290
    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 (Food)·F-1416-2014·2014-01-22

    Big Blue Fisheries Recalls Smoked Fish Products 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
    Variety Smoked Pack is sold in vacuum packed plastic packages, net weight 1.5 lbs., with label located on the front that include the pack date and AK 604. No label was provided.
    Category
    Food
    Distribution
    Distributed nationwide
  • 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: Wil
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-436-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Injectable Drug Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Papav/Phentol/PG E1 injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    Papav/Phentol/PG E1, 30 mg/1 mg/20 mcg/mL, injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-433-2014·2014-01-22

    Naloxone Injectable Recalled Due to Lack of Assurance of Sterility

    Specialty Medicine Compounding Pharmacy is recalling Naloxone HCL 0.4mg/mL injectable because sterility cannot be assured after a related product was found to be non-sterile.

    Product
    NALOXONE HCL* 0.4MG/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-414-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Combo Eye Gel Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Combo Eye Gel because sterility cannot be assured after another product was found non-sterile in the same environment.

    Product
    Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofenac sodium 0.1%, ciprofloxacin 0.3%, phenylephrine 10%, lidocaine jelly 2%), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    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-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 (Food)·F-1338-2014·2014-01-22

    Jensen's Recalls Hot Smoked Trout and Arctic Char Due to Labeling and Botulism Risk

    Jensen's Old Fashioned Smokehouse is recalling hot smoked trout and Arctic Char because they may lack 'KEEP FROZEN' labels, posing a risk of Clostridium botulinum contamination.

    Product
    Low salt, vacuum packaged, Hot Smoked Trout and Arctic Char. Clippership products are labeled in parts: "***IMPORTANT. Keep Frozen. Thaw under refrigeration immediately before use***".
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1402-2014·2014-01-22

    Josephson's Hot Smoked Pepper Atlantic Salmon Recalled for Botulism Risk

    Josephson's Smokehouse is recalling hot smoked pepper Atlantic salmon because the products were undercooked, posing a potential hazard of Clostridium botulinum toxin formation.

    Product
    Hot Smoked Pepper Atlantic Salmon, Item HS-C, vacuum packaged and either frozen or refrigerated, ranging in size between about one pound to eight pounds. The UPC for net weight 0.425 lbs. is 0 240120 813603. The label is read in part: HOT SMOKED PEPPERED ATLANTIC SALMON
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Drugs)·D-429-2014·2014-01-22

    Magnesium Sulfate Injection Recalled Due to Sterility Assurance Concerns

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

    Product
    Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, 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 (Drugs)·D-689-2014·2014-01-22

    Aidapak Recalls Mislabeled Pantoprazole Sodium Tablets

    Aidapak Services, LLC is recalling 20 mg Pantoprazole Sodium tablets that may be mislabeled as Fosinopril Sodium. The error involves a label mixup on repacked drugs.

    Product
    PANTOPRAZOLE SODIUM DR Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679043304
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-575-2014·2014-01-22

    FDA Recalls Mislabeled Quetiapine Fumarate Tablets Distributed by Aidapak

    Aidapak Services is recalling Quetiapine Fumarate tablets that may be mislabeled as Simvastatin. The FDA classifies this as a Class II recall.

    Product
    QUETIAPINE FUMARATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 47335090288
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-432-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Multitrace-4 Pediatric Injection

    Specialty Medicine Compounding Pharmacy is recalling Multitrace-4 pediatric injections because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    Multitrace-4 pediatric injection ( zinc sulfate usp granular heptahydrate, cupric sulfate pentahydrate usp, manganese sulfate monohydrate usp, chromium chloride hexahydrate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-410-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Acetylcysteine Ophthalmic Solution

    Specialty Medicine Compounding Pharmacy is recalling Acetylcysteine 20% Ophthalmic solution because sterility cannot be assured after a related product was found non-sterile.

    Product
    Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-649-2014·2014-01-22

    FDA Recalls Misoprostol Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling Misoprostol 200 mcg tablets because they may be mislabeled as Propranolol HCl or Sodium Chloride.

    Product
    MISOPROSTOL, Tablet, 200 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762500801
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-411-2014·2014-01-22

    FDA Recalls Aluminum Potassium Sulfate Sterile Powder Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Aluminum Potassium Sulfate Sterile powder because sterility cannot be assured after a related product was found non-sterile.

    Product
    Aluminum Potassium Sulfate Sterile powder, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-545-2014·2014-01-22

    Aidapak Recalls Torsemide Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Torsemide 10 mg tablets that may be mislabeled as Mexiletine HCl 200 mg capsules.

    Product
    TORSEMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 31722053001
    Category
    Drug
    Distribution
    4 states
  • 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-464-2014·2014-01-22

    Aidapak Recalls Calcium Carbonate Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 10,819 tablets of Calcium Carbonate +D3 because they may be mislabeled as Digoxin or Amantadine HCl.

    Product
    CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904323392.
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-594-2014·2014-01-22

    Aidapak Recalls Trazodone Tablets Due to Potential Label Mixup

    Aidapak Services, LLC is recalling Trazodone HCl 150 mg tablets because they may be mislabeled as Nicotine Polacrilex or Sennosides.

    Product
    traZODone HCl Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111044101
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-1421-2014·2014-01-22

    Glass Onion Catering Recalls Trader Joe's Greek Salad Due to E. coli Outbreak

    Glass Onion Catering is recalling Trader Joe's Classic Greek Salad because an investigation linked the supplier to an E. coli O157:H7 outbreak.

    Product
    Trader Joe's Classic Greek Salad with Feta Cheese, Cucumber Kalamata olives and Greek Dressing; (9 oz) (255 g) in plastic clam shell container. Packaged for Trader Joe's Manufactured by Glass Onion Catering, Richmond, CA
    Category
    Food
    Distribution
    2 states
  • 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 (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-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-449-2014·2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Testos Cypionate Injectable Due to Sterility Concerns

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

    Product
    TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-417-2014·2014-01-22

    Dexamethasone Solution Recalled Due to Lack of Sterility Assurance

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

    Product
    DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state

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