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Milk Side Effects

Common Milk Side Effects


The most commonly reported Milk side effects (click to view or check a box to report):

Haematochezia (16)
Constipation (15)
Rectal Haemorrhage (11)
Dyspnoea (9)
Abdominal Pain Upper (9)
Vomiting (8)
Diarrhoea (7)
Blood Potassium Decreased (7)
Abdominal Pain (6)
Blood Sodium Decreased (6)
Palpitations (5)
Heart Rate Increased (5)
Dizziness (5)
Back Pain (5)
Hypersensitivity (4)
Gastrooesophageal Reflux Disease (4)
Hypertension (4)
Pain In Extremity (4)
Nausea (4)
Muscle Spasms (4)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Milk Side Effects Reported to FDA

The following Milk reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Milk on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Hypoxia, Fluid Overload
This is a report of a 69-year-old female patient (weight: NA) from UNITED STATES, suffering from the following symptoms/conditions: constipation,nausea,pain, who was treated with Milk Of Magnesia Tab (dosage: NA, start time: May 07, 2012), combined with:
  • Ondansetron (Prn)
  • Morphine Sulfate
  • Magnesium Sulfate (Inj. 6 G, 4 G Every 4 Hr)
  • Oxycodone Hcl (Liquid. 5ml Every 4 Hours, 10 Ml At Bedtime)
  • Ipratropium Bromide (Neb Prn)
  • Albuterol (2.5 Ned Inhalation, Prn)
  • Salmeterol + Fluticasone (1 Df: 1 Puff. 500 Mcg+50mcg/puff)
  • Docusate (Solution 100 Mg/25 Ml)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Hypoxia
  • Fluid Overload
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Milk Of Magnesia Tab treatment in female patients, resulting in hypoxia side effect. The patient was hospitalized.

Weight Increased, Muscle Spasms, Joint Swelling, Stress, Gait Disturbance
This report suggests a potential Milk Of Magnesia Tab Weight Increased, Muscle Spasms, Joint Swelling, Stress, Gait Disturbance side effect(s) that can have serious consequences. A 66-year-old female patient (weight: NA) from UNITED STATES was diagnosed with the following symptoms/conditions: NA and used Milk Of Magnesia Tab (dosage: 1 Ml, Qd) starting Sep 24, 2011. Soon after starting Milk Of Magnesia Tab the patient began experiencing various side effects, including:
  • Weight Increased
  • Muscle Spasms
  • Joint Swelling
  • Stress
  • Gait Disturbance
Drugs used concurrently:
  • Motrin
  • Prolia (60 Mg, Q6mo)
Although Milk Of Magnesia Tab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as weight increased, may still occur.

Anxiety, Palpitations, Dyspnoea
This Anxiety, Palpitations, Dyspnoea problem was reported by a physician from UNITED STATES. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Jun 20, 2011 this consumer started treatment with Milk Of Magnesia Tab (dosage: NA). The following drugs were being taken at the same time:
  • Dulcolax
  • Gilenya (5 Mg, Qd)
  • Colace
  • Zofran
  • Cephalexin
  • Rebif
  • Lotrel
  • Toprol-xl
When commencing Milk Of Magnesia Tab, the patient experienced the following unwanted symptoms/side effects:
  • Anxiety
  • Palpitations
  • Dyspnoea
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as anxiety, may become evident only after a product is in use by the general population.

Subdural Haemorrhage, Dysphagia, Cerebral Haematoma, Rectal Haemorrhage, Loss Of Consciousness, Grand Mal Convulsion, Haemorrhagic Stroke, Unresponsive To Stimuli, Ischaemic Stroke
This is a report of a female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Milk Of Magnesia Tab (dosage: NA) starting Dec 01, 2011. Concurrently used drugs:
  • Hydralazine Hcl
  • Acetaminophen
  • Ciprofloxacin Hcl
  • Magnesium Hydroxide Tab
  • Tekturna
  • Xarelto (15 Mg Daily Po)
  • Levemir
  • Protonix
Soon after that, the consumer experienced the following side effects:
  • Subdural Haemorrhage
  • Dysphagia
  • Cerebral Haematoma
  • Rectal Haemorrhage
  • Loss Of Consciousness
  • Grand Mal Convulsion
  • Haemorrhagic Stroke
  • Unresponsive To Stimuli
  • Ischaemic Stroke
This opens a possibility that Milk Of Magnesia Tab treatment could cause the above reactions, including subdural haemorrhage, and some female subjects may be more susceptible.


Deep Vein Thrombosis, Pain In Extremity, Chest Pain, Dyspnoea, Pulmonary Embolism
A 40-year-old female patient (weight: NA) from UNITED STATES with the following symptoms/conditions: constipation started Milk Of Magnesia Tab treatment (dosage: Unk) on Jun 14, 2007. Soon after starting Milk Of Magnesia Tab treatment, the subject experienced various side effects, including:
  • Deep Vein Thrombosis
  • Pain In Extremity
  • Chest Pain
  • Dyspnoea
  • Pulmonary Embolism
Concurrently used drugs:
  • Aspirin
  • Ibuprofen
  • Bentyl (20 Mg, Unk)
  • Yaz (Unk)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Milk Of Magnesia Tab.

Therapeutic Response Unexpected, Overdose, Off Label Use
A 69-year-old female patient from UNITED STATES (weight: NA) experienced symptoms, such as: NA and was treated with Milk Of Magnesia Tab(dosage: 3 Tsp, At Night). The treatment was initiated on Jun 01, 2011. After that a consumer reported the following side effect(s):
  • Therapeutic Response Unexpected
  • Overdose
  • Off Label Use
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Milk Of Magnesia Tab efficacy:
  • Benefiber W/ Wheat Dextrin (3 Tsp, Tid)
  • Benefiber W/ Wheat Dextrin (9 Tsp, Tid)


Gastric Ulcer
In this report, Milk Of Magnesia Tab was administered for the following condition: abdominal discomfort.A 32-year-old male consumer from UNITED STATES (weight: NA) started Milk Of Magnesia Tab treatment (dosage: 2 Df, Once, Bottle Size 12 Oz) on Apr 29, 2012.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Gastric Ulcer
A possible interaction with other drugs could have contributed to this reaction: NA.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Milk Of Magnesia Tab treatment could be related to the listed above side effect(s).

Dyspnoea, Abdominal Distension, Constipation, Abdominal Discomfort
This is a report of the following Milk Of Magnesia Tab side effect(s):
  • Dyspnoea
  • Abdominal Distension
  • Constipation
  • Abdominal Discomfort
A 68-year-old male patient from UNITED STATES (weight: NA) presented with the following condition: constipation and received a treatment with Milk Of Magnesia Tab (dosage: 3 Df (tbsp) Once) starting: Apr 22, 2012.The following concurrently used drugs could have generated interactions: NA.This report suggests that a Milk Of Magnesia Tab treatment could be associated with the listed above side effect(s).

Change Of Bowel Habit, Diarrhoea, Proctalgia, Anal Haemorrhage
This Milk Of Magnesia Tab report was submitted by a 68-year-old female consumer from UNITED STATES (weight: NA). The patient was diagnosed with: constipation and Milk Of Magnesia Tab was administered (dosage: Unk) starting: Apr 09, 2012. The consumer developed a set of symptoms:
  • Change Of Bowel Habit
  • Diarrhoea
  • Proctalgia
  • Anal Haemorrhage
Other drugs used simultaneously:
  • Multi-vitamin
  • Complex B
  • Ascorbic Acid
  • Neurontin
  • Colace
  • Vitamin D
  • Aspirin
  • Vicodin
Those unexpected symptoms could be linked to a Milk Of Magnesia Tab treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Nausea, Abdominal Pain Upper, Dizziness, Urine Output Decreased
This is a report of a possible correlation between Milk Of Magnesia Tab use and the following symptoms/side effect(s):
  • Nausea
  • Abdominal Pain Upper
  • Dizziness
  • Urine Output Decreased
which could contribute to an assessment of Milk Of Magnesia Tab risk profile.A 71-year-old male consumer from UNITED STATES (weight: NA) was suffering from constipation and was treated with Milk Of Magnesia Tab (dosage: NA) starting NS.Other concurrent medications: NA.

Neutrophil Count Decreased, White Blood Cell Count Decreased
A 28-year-old male patient from UNITED STATES (weight: NA) presented with the following symptoms: NA and after a treatment with Milk Of Magnesia Tab (dosage: NA) experienced the following side effect(s):
  • Neutrophil Count Decreased
  • White Blood Cell Count Decreased
The treatment was started on Jan 26, 2012. Milk Of Magnesia Tab was used in combination with the following drugs:
  • Acetaminophen
  • Olanzapine
  • Clozapine (100.0 Mg)
  • Multi-vitamins
  • Docusate
  • Levothyroxine Sodium
  • Fluphenazine
  • Clozapine (125 Mg)
This report could alert potential Milk Of Magnesia Tab consumers.

Dizziness, Nausea, Abdominal Pain Upper, Urine Output Decreased
In this report, a 71-year-old male patient from UNITED STATES (weight: NA) was affected by a possible Milk Of Magnesia Tab side effect.The patient was diagnosed with constipation. After a treatment with Milk Of Magnesia Tab (dosage: Unk, start date: NS), the patient experienced the following side effect(s):
  • Dizziness
  • Nausea
  • Abdominal Pain Upper
  • Urine Output Decreased
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Milk Of Magnesia Tab treatment.

Heart Rate Irregular, Dyspnoea, Constipation, Product Quality Issue, Overdose
This is a report of a 93-year-old male patient from UNITED STATES (weight: NA), who used Milk Of Magnesia Tab (dosage: , Oral) for a treatment of constipation. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Heart Rate Irregular
  • Dyspnoea
  • Constipation
  • Product Quality Issue
  • Overdose
The following drugs could possibly have interacted with the Milk Of Magnesia Tab treatment
  • Miralax
The patient was hospitalized.Taken together, these observations suggest that a Milk Of Magnesia Tab treatment could be related to side effect(s), such as Heart Rate Irregular, Dyspnoea, Constipation, Product Quality Issue, Overdose.

Atrial Fibrillation, Osteoarthritis, Myalgia, Atrial Tachycardia, Pneumonitis, Confusional State, Lethargy, Tremor, Cerebral Ventricle Dilatation
This atrial fibrillation side effect was reported by a consumer or non-health professional from UNITED STATES. A 67-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Milk Of Magnesium (dosage: NA), which was started on Jul 07, 2006. Concurrently used drugs:
  • Klonopin
  • Toprol-xl
  • Coreg
  • Vitamin B Complex Cap
  • Digoxin (0.25mg;unk;po)
  • Furosemide
  • Singulair
  • Celexa
When starting to take Milk Of Magnesium the consumer reported the following symptoms:
  • Atrial Fibrillation
  • Osteoarthritis
  • Myalgia
  • Atrial Tachycardia
  • Pneumonitis
  • Confusional State
  • Lethargy
  • Tremor
  • Cerebral Ventricle Dilatation
The patient was hospitalized. These side effects may potentially be related to Milk Of Magnesium.

Supraventricular Tachycardia, Staphylococcal Sepsis, Colitis Ischaemic
This is a Milk Of Magnesia Tab side effect report of a 49-year-old female patient (weight:NA) from UNITED STATES, suffering from the following symptoms/conditions: NA, who was treated with Milk Of Magnesia Tab (dosage:NA, start time: Mar 11, 2009), combined with:
  • Atenolol
  • Cymbalta
  • Rozerem
  • Potassium Chloride
  • Topamax
  • Lithium Carbonate
  • Protonix
  • Dulcolax
, and developed a serious reaction and a supraventricular tachycardia side effect. The patient presented with:
  • Supraventricular Tachycardia
  • Staphylococcal Sepsis
  • Colitis Ischaemic
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Milk Of Magnesia Tab treatment in female patients suffering from NA, resulting in supraventricular tachycardia.

Lip Disorder, Abdominal Pain Upper, Haemorrhage, Lip Swelling
This report suggests a potential Milk Of Magnesia Tab lip disorder side effect(s) that can have serious consequences. A 59-year-old female patient from UNITED STATES (weight:NA) was diagnosed with the following health condition(s): constipation and used Milk Of Magnesia Tab (dosage: 1 Df, Qd) starting Feb 19, 2012. Soon after starting Milk Of Magnesia Tab the patient began experiencing various side effects, including:
  • Lip Disorder
  • Abdominal Pain Upper
  • Haemorrhage
  • Lip Swelling
Drugs used concurrently:NA. Although Milk Of Magnesia Tab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as lip disorder, may still occur.

Food Allergy, Pruritus
This food allergy problem was reported by a pharmacist from UNITED STATES. A 83-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): NA.On Dec 01, 2011 a consumer started treatment with Milk Thistle (dosage: NA). The following drugs/medications were being taken at the same time:
  • Omeprazole
  • Cetirizine
  • Letairis (Letairis 5 Mg Daily)
  • Amlodipine
When commencing Milk Thistle, the patient experienced the following unwanted symptoms /side effects:
  • Food Allergy
  • Pruritus
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as food allergy, may become evident only after a product is in use by the general population.

Injection Site Haemorrhage, Musculoskeletal Pain, Blood Disorder, Contusion, Injection Site Pain, Pain In Extremity
This is a Milk Thistle side effect report of a male patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Milk Thistle (dosage: NA) starting Jul 01, 2011. Concurrently used drugs:
  • Humira
  • Vitamin D
  • Citalopram
  • Acidophilus
  • Vitamin E
  • Azathioprine
  • Amitriptyline Hcl
Soon after that, the consumer experienced the following of symptoms:
  • Injection Site Haemorrhage
  • Musculoskeletal Pain
  • Blood Disorder
  • Contusion
  • Injection Site Pain
  • Pain In Extremity
This opens a possibility that Milk Thistle could cause injection site haemorrhage and that some male patients may be more susceptible.

Joint Swelling, Gait Disturbance, Weight Increased, Stress, Muscle Spasms
A 66-year-old female patient (weight: NA) from UNITED STATES with the following symptoms: NA started Milk Of Magnesia Tab treatment (dosage: 1 Ml, Qd) on Sep 01, 2011. Soon after starting Milk Of Magnesia Tab treatment, the consumer experienced several side effects, including:
  • Joint Swelling
  • Gait Disturbance
  • Weight Increased
  • Stress
  • Muscle Spasms
. Concurrently used drugs:
  • Motrin
  • Prolia (60 Mg, Q6mo)
This finding indicates that some patients can be more vulnerable to developing Milk Of Magnesia Tab side effects, such as joint swelling.

Dysgeusia
This dysgeusia side effect was reported by a health professional from UNITED STATES. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Milk Thistle (dosage: NA), which was started on Aug 31, 2011. Concurrently used drugs:
  • Fish Oil
  • Pegasys
  • Procrit
  • Hydroxychloroquine Sulfate
  • Victrelis (800 Mg;tid; Po)
  • Alpha-lipoic Acid
  • Ribavirin
  • Neupogen
.When starting to take Milk Thistle the consumer reported symptoms, such as:
  • Dysgeusia
These side effects may potentially be related to Milk Thistle.

Bronchitis, Anaemia, Fatigue, Gingival Bleeding
This is a report of a male patient (weight: NA) from UNITED STATES, suffering from the following symptoms/conditions: NA, who was treated with Milk Thistle (dosage: NA, start time: Dec 08, 2008), combined with:
  • Uroxatral
  • Coq10
  • Decadron
  • Nexium
  • Cat's Claw
  • Iron
  • Avodart
  • Gluco/chon
and developed a serious reaction and side effect(s). The consumer presented with:
  • Bronchitis
  • Anaemia
  • Fatigue
  • Gingival Bleeding
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Milk Thistle treatment in male patients, resulting in bronchitis side effect.

Chest Discomfort, Gastrointestinal Haemorrhage, Duodenal Ulcer, Anxiety, Non-cardiac Chest Pain, Gastrooesophageal Reflux Disease, Renal Failure Chronic, Abdominal Pain Lower, Pyrexia
This report suggests a potential Milk Of Magnesia Tab Chest Discomfort, Gastrointestinal Haemorrhage, Duodenal Ulcer, Anxiety, Non-cardiac Chest Pain, Gastrooesophageal Reflux Disease, Renal Failure Chronic, Abdominal Pain Lower, Pyrexia side effect(s) that can have serious consequences. A female patient (weight: NA) from UNITED STATES was diagnosed with the following symptoms/conditions: NA and used Milk Of Magnesia Tab (dosage: NA) starting Mar 05, 2008. Soon after starting Milk Of Magnesia Tab the patient began experiencing various side effects, including:
  • Chest Discomfort
  • Gastrointestinal Haemorrhage
  • Duodenal Ulcer
  • Anxiety
  • Non-cardiac Chest Pain
  • Gastrooesophageal Reflux Disease
  • Renal Failure Chronic
  • Abdominal Pain Lower
  • Pyrexia
Drugs used concurrently:
  • Aldactone
  • Tasigna (400 Mg, Bid)
  • Actos (Unk)
  • Glimepiride
  • Protonix
The patient was hospitalized. Although Milk Of Magnesia Tab demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as chest discomfort, may still occur.

Tremor
This Tremor problem was reported by a consumer or non-health professional from UNITED STATES. A 62-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Milk Thistle (dosage: NA). The following drugs were being taken at the same time:
  • Enbrel (50 Mg, Qwk)
  • Asa Arthritis Strength Aspirin (81 Mg, Unk)
  • Multivitamin /00097801/
  • Norco (325 Mg, Unk)
  • Vitamin D (1000 Unit, Unk)
  • Levothyroxine Sodium (112 Mci/mug, Unk)
  • Flaxseed Oil
  • Vitamin E /00110501/ (1000 Unit, Unk)
When commencing Milk Thistle, the patient experienced the following unwanted symptoms/side effects:
  • Tremor
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as tremor, may become evident only after a product is in use by the general population.

Hepatic Failure, Renal Failure, Heparin-induced Thrombocytopenia, Mobility Decreased, Hyperhidrosis, Convulsion, Vomiting, Aphasia
This is a report of a 74-year-old male patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Milk Of Magnesia Tab (dosage: NA) starting Mar 20, 2008. Concurrently used drugs:
  • Prochlorperazine
  • Acetaminophen
  • Insulin Glargine
  • Metformin Hcl
  • Aspirin
  • Ondansetron
  • Phenytoin
  • Lantus
Soon after that, the consumer experienced the following side effects:
  • Hepatic Failure
  • Renal Failure
  • Heparin-induced Thrombocytopenia
  • Mobility Decreased
  • Hyperhidrosis
  • Convulsion
  • Vomiting
  • Aphasia
This opens a possibility that Milk Of Magnesia Tab treatment could cause the above reactions, including hepatic failure, and some male subjects may be more susceptible.

Pulmonary Function Test Decreased, Infection, Pallor, Abdominal Pain, Vomiting, Blood Pressure Decreased, Helicobacter Infection, Nausea, Renal Failure
A female patient (weight: NA) from UNITED STATES with the following symptoms/conditions: NA started Milk Of Magnesia Tab treatment (dosage: 30 Ml, Tid) on May 01, 2011. Soon after starting Milk Of Magnesia Tab treatment, the subject experienced various side effects, including:
  • Pulmonary Function Test Decreased
  • Infection
  • Pallor
  • Abdominal Pain
  • Vomiting
  • Blood Pressure Decreased
  • Helicobacter Infection
  • Nausea
  • Renal Failure
Concurrently used drugs:
  • Peri-colace (2 Df, Bid)
  • Advair Diskus 100/50
  • Amoxicillin (1000 Mg, Bid)
  • Norco (1 Df, Every 6 Hours)
  • Reglan (10 Mg, Unk)
  • Protonix (40 Mg, Daily)
  • Albuterol (2.5 Mg, Per 3 Ml)
  • Klor-con (20 Meq, Bid)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Milk Of Magnesia Tab.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


    Discuss Milk Side Effects

    Did You Have a Milk Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Milk for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
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    Milk Safety Alerts, Active Ingredients, Usage Information

    NDC0054-3567
    TypeHUMAN OTC DRUG
    Proprietary NameMilk of Magnesia
    NameMilk of Magnesia
    Dosage FormCONCENTRATE
    RouteORAL
    On market since20010312
    LabelerRoxane Laboratories, Inc.
    Active Ingredient(s)MAGNESIUM HYDROXIDE
    Strength(s)2400
    Unit(s)mg/10mL
    Pharma Class

    More About Milk

    Side Effects reported to FDA: 128

    Milk safety alerts: 2014 2013 2002

    Reported deaths: 6

    Reported hospitalizations: 33

    Z Pro High Protein Supplement: Recall - Undeclared Soy And Milk

     

    [Posted 02/04/2013]

    AUDIENCE: Consumer, Patient, Surgery

    ISSUE: R-Kane Products, Inc, Pennsauken, NJ is recalling all outstanding supplies of its Z PRO HIGH PROTEIN SUPPLEMENT, because it contains soy and milk, allergens which are not declared on the labels of individual packets of the product. People who have an allergy or severe sensitivity to soy or milk run the risk of a serious or life-threatening allergic reaction if they consume these products.

    BACKGROUND: Z PRO HIGH PROTEIN SUPPLEMENT was distributed nationwide between January 1, 2006 and January 24, 2013, to bariatric centers and bariatric physicians who dispense the product to patients who have undergone bariatric surgery. This recall was initiated after an FDA inspection noted that these allergens were not disclosed on the inner packets of the product. Product shipped after January 24, 2013 contains the allergen disclosure on both the outer box packaging and the individual inner packets of the product. No illnesses have been reported to date.

    RECOMMENDATION: Additional information on what consumers should do with the product maybe be obtained by calling Robert Kaskey, 1-856-663-0644 (M–F 10 AM to 4:00 PM EST).

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


    [01/30/2013 - Press Release - R-Kane Products, Inc.]

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