February 2017 recalls

436 recalls were announced in February 2017.

What the numbers show

Critical: 35
Severe: 156
High: 146
Moderate: 78
Low: 21

Of the 436 recalls this month scored against our rubric, 8% are Critical, 36% are Severe.

Which agencies issued them

401–436 of 436

ModerateFDA (Devices)·Z-1068-2017·2017-02-01
Binding Site IgG4 Subclass Kit Recalled for Inaccurate Results
The Binding Site Group is recalling Human IgG4 Subclass kits because high IgG4 levels can cause spuriously low results.
Product
Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1093-2017·2017-02-01
Acumedia Tryptic Soy Agar Recalled Due to Precipitate Formation
Acumedia is recalling Tryptic Soy Agar because precipitate may form in plates, potentially leading to inaccurate microbial counts.
Product
Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
Category
Medical Device
Distribution
21 states
ModerateFDA (Drugs)·D-0437-2017·2017-02-01
Roxane Recalls Furosemide Tablets Due to Unusually Thick Tablet Report
Roxane Laboratories is recalling 6,493 bottles of Furosemide 20 mg tablets because a complaint reported an unusually thick tablet.
Product
FUROSEMIDE — FUROSEMIDE (FUROSEMIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0441-2017·2017-02-01
Mylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder
Mylan LLC is recalling specific lots of Temozolomide Capsules, 100 mg, because customer complaints reported broken or crushed capsules resulting in loose powder in the bottles.
Product
Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1078-2017·2017-02-01
Sekisui Diagnostics Ammonia L3K Assay Recalled for Performance Issues
Sekisui Diagnostics is recalling specific lots of the Ammonia L3K Assay because atypical optical density decreases may impact performance at the high end of the linear range.
Product
Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
Category
Medical Device
Distribution
12 states
ModerateFDA (Food)·F-1358-2017·2017-02-01
Berner Food & Beverage Recalls Four Cheese Alfredo Pasta Sauce
Berner Food & Beverage is recalling 850 cases of Four Cheese Alfredo Pasta Sauce due to contamination with spoilage bacteria.
Product
Four Cheese Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 425g; Glass jar, metal lid; UPC 70038627838, 36800334793 or 041498198084
Category
Food
Distribution
7 states
ModerateFDA (Food)·F-1353-2017·2017-02-01
IQ Formulations Recalls Pre-Workout Powder Containing Unapproved Ingredients
IQ Formulations is recalling P.S.P. Pre-Workout powder because it contains picamilon and/or methylpentane citrate, which are not recognized as dietary ingredients.
Product
P.S.P., Pre-Workout, Physique Stimulating Pre-workout, Powder, 360 g, green apple (UPC 764779-360344). Brand: Metabolic Nutrition.
Category
Food
Distribution
0 states
ModerateFDA (Food)·F-1360-2017·2017-02-01
Berner Food Recalls Our Family Alfredo Pasta Sauce Due to Bacteria
Berner Food & Beverage, LLC is recalling Our Family Alfredo Pasta Sauce contaminated with spoilage bacteria. Consumers should discard the product.
Product
Our Family Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 425g; Glass jar, metal lid; UPC 70253266867
Category
Food
Distribution
7 states
ModerateFDA (Devices)·Z-1100-2017·2017-02-01
PerkinElmer AutoDELFIA Plate Processor Recalled for Potential Loading Failures
PerkinElmer is recalling AutoDELFIA Plate Processors with Version 3.0 software due to potential plate loading failures that could affect clinical assay results.
Product
AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1057-2017·2017-02-01
On-X Chord-X Chordal Sizer Recalled for Manufacturing Defects
On-X Life Technologies is recalling 45 units of the Chord-X Chordal Sizer due to manufacturing defects including burrs, particulate, hair, and assembly errors.
Product
Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve…
Category
Medical Device
Distribution
7 states
ModerateFDA (Drugs)·D-0443-2017·2017-02-01
Mylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder
Mylan LLC is recalling Temozolomide Capsules, 180 mg, due to customer complaints of broken or crushed capsules resulting in loose powder in the bottles.
Product
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottles (NDC 0378-5264-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1352-2017·2017-02-01
Metabolic Nutrition Pre-Workout Powder Recalled for Unapproved Ingredients
IQ Formulations is recalling Metabolic Nutrition P.S.P. Pre-Workout powder because it contains Picamilon and/or methylpentane citrate, which are not recognized as dietary ingredients.
Product
P.S.P., Pre-Workout, Physique Stimulating Pre-workout, Powder, 360 g, fruit punch (UPC 764779-360238). Brand: Metabolic Nutrition.
Category
Food
Distribution
0 states
ModerateFDA (Devices)·Z-1086-2017·2017-02-01
Atrium Medical Recalls Oasis Blood Recovery Drains Due to Sterility Issues
Atrium Medical is recalling Oasis Blood Recovery Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.
Product
Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood Recovery drain with in-line connector 3652-100 Oasis Double Blood Recovery drain with in-line connectors - 2 patient lines connected by one Y connector Product Usage: To evacuate air and/or fluid…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0440-2017·2017-02-01
Teva Recalls Amoxicillin Oral Suspension Due to Low Potency
Teva Pharmaceuticals is recalling specific lots of Amoxicillin for Oral Suspension because stability testing revealed the medication was below the required potency standard.
Product
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73
Category
Drug
Distribution
1 state
ModerateFDA (Devices)·Z-1087-2017·2017-02-01
Atrium Medical 400 Series Express Drains Recalled for Non-Sterile Packaging
Atrium Medical is recalling 400 Series Express Drains because the outer packaging is not sterile. The recall affects approximately 1.4 million cases distributed worldwide.
Product
Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with in-line connector 4000-100P Express PreFilled Chest Drain 4020-100N Express dual chamber drain with in-line connectors ( 2 Patient Tubes) 4050-100N Express Blood Recovery…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0446-2017·2017-02-01
Sun Pharmaceutical Recalls BuPROPion Hydrochloride Tablets for Dissolution Failures
Sun Pharmaceutical Industries is recalling 11,618 bottles of buPROPion Hydrochloride Extended-release Tablets due to failed dissolution specifications and stability issues.
Product
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0442-2017·2017-02-01
Mylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder
Mylan LLC is recalling Temozolomide Capsules, 140 mg, due to customer complaints of broken or crushed capsules resulting in loose powder in the bottles.
Product
Temozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottles (NDC 0378-5263-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1072-2017·2017-02-01
Binding Site IgG Subclass Reagent Kits Recalled for Inaccurate Results
The Binding Site Group is recalling Human IgG Subclass Liquid Reagent Kits because high IgG4 levels can cause spuriously low test results.
Product
Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ Analyser Product Code: NK001.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1071-2017·2017-02-01
Binding Site IgG4 Reagent Kits Recalled for Inaccurate Results
The Binding Site Group is recalling Human IgG4 Subclass Liquid Reagent Kits because they may yield spuriously low results for samples with extremely high IgG4 levels.
Product
Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product Code: NK009.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1073-2017·2017-02-01
Binding Site IgG4 Kit Recalled for Inaccurate Results in High Levels
The Binding Site Group is recalling MininephThl Human IgG4 Kits because samples with extremely high IgG4 levels may yield spuriously low results.
Product
MininephThl Human lgG4 Kit Product Code: ZK009.LR This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism…
Category
Medical Device
Distribution
6 states
ModerateFDA (Food)·F-1347-2017·2017-02-01
IQ Formulations Recalls E.S.P. Pre-Workout Powder for Unapproved Ingredients
IQ Formulations is recalling E.S.P. Pre-Workout powder because it contains picamilon and/or methylpentane citrate, which are not recognized as dietary ingredients.
Product
E.S.P. Pre-Workout, Energy Stimulant Pre-workout, Powder, 300 g, blue raspberry flavor (UPC 764779-410728.
Category
Food
Distribution
0 states
ModerateFDA (Food)·F-1344-2017·2017-02-01
Dr. Pepper 2-Liter Bottles Recalled for Potential Undeclared Aspartame
Coca-Cola Consolidated is recalling 2-liter bottles of Dr. Pepper that may contain Diet Dr. Pepper with undeclared aspartame.
Product
Dr. Pepper, 2 Liters (2.1 qt) plastic bottles, Bottled under the authority of Dr. Pepper Company, 5301 Legacy Drive, Plano, TX 75024.
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-1084-2017·2017-02-01
Atrium Medical Oasis Pediatric Drain Recalled for Non-Sterile Packaging
Atrium Medical is recalling Oasis Pediatric Drains because the outer packaging is not sterile. The recall covers 964,463 US cases and 521,975 international cases.
Product
Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, ¿ in. tubing, Sims and Pedi connector in bag on back of drain 3612-400 Oasis Infant/Pediatric drain with no in-line connector, ¿ in. tubing, Sims and Pedi connector…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0447-2017·2017-02-01
Cambrex Recalls Mesalamine API Due to Stainless Steel Particulate Matter
Cambrex Charles City Inc is recalling Mesalamine API due to the presence of stainless steel particulate matter detected in the finished product.
Product
Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboard drums. Net weight 40 kg
Category
Drug
Distribution
1 state
ModerateFDA (Devices)·Z-1088-2017·2017-02-01
Atrium Medical Express Mini 500 Dry Seal Drain Recall
Atrium Medical is recalling Express Mini 500 dry seal drains because the outer packaging is not sterile.
Product
Atrium Medical 16400 Express Mini 500 dry seal drain Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative collection and reinfusion of autologous…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1104-2017·2017-02-01
Mesa Laboratories Recalls ProSpore Biological Indicators Due to Reduced Resistance
Mesa Laboratories is recalling ProSpore 4 mL Ampoule Biological Indicators because product resistance fell outside label claims within the expiration date.
Product
ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care…
Category
Medical Device
Distribution
11 states
LowFDA (Devices)·Z-1102-2017·2017-02-01
PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures
PerkinElmer is recalling AutoDELFIA systems with V3.0 software due to potential plate loading failures that could affect clinical assay results.
Product
DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0448-2017·2017-02-01
Roxane Recalls Azelastine Nasal Spray Due to Defective Delivery System
Roxane Laboratories is recalling 74,108 bottles of Azelastine Hydrochloride Nasal Spray because the delivery system failed droplet size testing.
Product
Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293-99
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1101-2017·2017-02-01
PerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures
PerkinElmer is recalling AutoDELFIA systems with Version 3.0 software due to potential plate loading failures that could affect clinical assay results.
Product
Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Product Number: 1235-8110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1105-2017·2017-02-01
Smiths Medical Recalls NORMFlow H-1100 Irrigation Fluid Warmer for Labeling Errors
Smiths Medical is recalling one NORMFlow H-1100 Irrigation Fluid Warmer in Sweden due to incorrect Spanish labels instead of English.
Product
NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. Product Usage: NORMOFLO¿ H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer…
Category
Medical Device
Distribution
0 states
LowFDA (Drugs)·D-0438-2017·2017-02-01
Qualitest Recalls Dexamethasone Elixir Due to Failed Impurity Specifications
Vintage Pharmaceuticals is recalling 2,568 bottles of Dexamethasone Elixir because the product failed impurity and degradation specifications.
Product
DEXAMETHASONE ELIXIR, USP, 0.5 mg/5 mL, 8 fl.oz., Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL, NDC 0603-1147-56
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1075-2017·2017-02-01
Pentax Rigid Laryngostroboscopes Field Correction for Instructions for Use
Pentax of America is revising the Instructions for Use for Rigid Laryngostroboscopes Models 9106 and 9108.
Product
Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1089-2017·2017-02-01
Binding Site IgG4 Kit Recalled for Incorrect Product Insert Information
The Binding Site Group is recalling Optilite IgG4 Kits because the product insert does not reflect a change to the measuring range.
Product
Optilite IgG4 Kit Product Code: LK009.OPT.A
Category
Medical Device
Distribution
8 states
LowFDA (Drugs)·D-0439-2017·2017-02-01
Actavis Recalls Albuterol Sulfate Inhalation Solution Due to Impurities
Actavis Inc is recalling specific lots of Albuterol Sulfate Inhalation Solution because the product failed impurity specifications for a known degradant.
Product
Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories Inc., Corona, CA 92880 USA, Mfd. by Cipla Ltd. Verna, Goa India, NDC 0591-3467-53
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1060-2017·2017-02-01
GE OEC 9900 Elite Surgical Carts Recalled for Documentation Updates
GE Healthcare is updating user documentation for OEC 9900 Elite surgical carts to clarify maintenance and component replacement frequencies.
Product
OEC 9900 Elite. MDL Numbers: D148942, D155043
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1059-2017·2017-02-01
GE OEC 9800 Surgical Table Field Action for Documentation Updates
GE Healthcare is updating user documentation for OEC 9800 surgical tables to clarify maintenance and component replacement schedules.
Product
OEC 9800. MDL Numbers: D222250, D141598
Category
Medical Device
Distribution
0 states

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