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FDA RECALL – PROLAB NUTRITION INC.

Prolab Proactively Recalls Some Protein Products in Order to Correct Labeling for Items That May Have Undeclared Milk and/or Wheat and Gluten Allergens

Company Alerts Consumers and Distributors That Undeclared Milk and/or Wheat and Gluten Allergens May Exist In Some PROLAB Protein Products

PROLAB NUTRITION INC. (PROLAB) is recalling some of its protein items that may contain undeclared milk, wheat and gluten allergens. People with an allergy or severe sensitivity to milk and/or wheat and gluten allergens may run the risk of a serious or life-threatening allergic reaction if they consume products containing these allergens. For this reason, below is a list of the protein products that PROLAB is proactively recalling, although no illnesses or discomfort has been reported to date:

Item Description EAN/UPC
Contains Undeclared MILK and WHEAT/GLUTEN
PROLAB® Pure Whey, Milk Chocolate, 5 lb. (V3) 750902201929
PROLAB® Pure Whey, Vanilla Créme, 2 lb. (V3) 750902201875
PROLAB® Pure Whey, Wild Strawberry, 5 lb. (V3) 750902201936
PROLAB® Pure Whey, Wild Strawberry, 2 lb. (V3) 750902101557
Contains Undeclared WHEAT/GLUTEN
PROLAB® Advanced Pure Whey Protein, Milk Chocolate, 2 lb. (V3) 750902201301
PROLAB® Advanced Pure Whey Protein, Vanilla Créme, 2 lb. (V3) 750902201349
PROLAB® Advanced Pure Whey Protein, Wild Strawberry, 2 lb. (V3) 750902201271
PROLAB® Pure Whey, Milk Chocolate, 2 lb. (V3)
PROLAB® Pure Whey, Milk Chocolate, 16 g Sample Packet
750902201882
PROLAB® Pure Whey, Vanilla Créme, 5 lb. (V3)
PROLAB® Pure Whey, Vanilla Créme, 16 g Sample Packet
750902201912
PROLAB® Pure Whey, Wild Strawberry, 16 g Sample Packet
PROLAB® Whey Isolate Protein, Milk Chocolate, 2 lb. (V3) 750902201851
PROLAB® Whey Isolate Protein, Vanilla Créme, 2 lb. (V3) 750902201813
PROLAB® Whey Isolate Protein, Wild Strawberry, 2 lb. (V3) 75090220183

 

PROLAB initiated this recall immediately following the discovery that the packaging label of some distributed protein items did not reveal the presence of milk and/or wheat and gluten allergens in the products. PROLAB’s product manufacturer, Nature’s Products, Inc. (NPI), informed PROLAB that the raw material NPI used to manufacture the abovementioned products were not properly labeled.

According to Jenia Khudagulyan, Chief Operating Officer for PROLAB’s parent company, “PROLAB values consumers and their health, and it is the company’s goal to accurately convey what its products contain in order to ensure that consumers’ health is protected at the highest possible level. We discovered that some PROLAB protein items were not properly labeled for milk and/or wheat and gluten allergen content, and we immediately took precautionary measures by proactively recalling the affected products which will be re-released at a later date with corrected labels.

The affected products listed in this press release were distributed internationally — by retail stores, mail order, and direct delivery — in the following states, provinces, and countries: Alabama; California; Connecticut; Florida; Georgia; Idaho; Illinois; Indiana; Iowa; Kansas; Maryland; Massachusetts; Michigan; Minnesota; Missouri; Montana; Nevada; New Hampshire; New Jersey; New Mexico; New York; North Carolina; Ohio; Oklahoma; Pennsylvania; South Dakota; Tennessee; Texas; Utah; Vermont; Virginia; Washington; West Virginia; Wyoming; Ontario, Canada; Australia; Malaysia; and Russia.

Consumers who have purchased these items and wish to return them may do so — used or un-used — to the place of purchase for a full refund. For more information or any questions regarding PROLAB products, interested persons may contact the parent company (Natrol) by emailing customer-service@natrol.com or by calling the U.S. toll-free consumer relations line at 1-800-262-8765 from 5:30 a.m. to 2:30 p.m. Pacific Standard Time.

Source:  fda.gov


Nursing Home Negligence

Falls in Nursing Homes

Litigators who work with cases involving long term care know how significant the issue of falls can be. Falls are the leading cause of injury and death by injury in adults over 65. Approximately half of the 1.6 million nursing home residents in the U.S. fall each year, and a report by the Office of the Inspector General found that about 10% of Medicare skilled nursing residents experience a fall resulting in significant injury; and, more than 1/3 of hospital falls result in injury. In the rehab setting, rates are often higher – for example, fall rates among stroke patients have been shown to be very high. Immobility and falls can lead to poor outcomes.

Fear of falling is defined as a geriatric syndrome. It not only occurs in older adults who have fallen, but in those with impaired mobility and is associated with decreased physical ability and depression. Care of older adults requires that clinicians be aware of the myriad of issues related to falls including knowledge of this syndrome, increased risk and interventions needed to prevent injury related to falls.

Just about every resident in a long term care setting, including assisted living and sub-acute rehab, is at risk for falling. Between medications, functional and medical issues and advancing age, older adults in most settings are prone to falling.

There are well established standards of care related to fall prevention; but, as I continue to review records related to issues like falls, I am amazed at how often these basic standards are not being practiced. The basics of a fall prevention program include assessment and ongoing reassessment of risk, ensuring a safe environment, medication review, providing therapy as needed, individualized interventions, and staff education.

Basic nursing practice includes assessment, planning (Care plan), putting interventions in place and then evaluating outcomes to determine if those interventions are appropriate and effective. Assessment includes completing fall risk assessments on admission and then as needed. Very often, the fall risk assessments completed by nurses in LTC are inaccurate. The tools utilized in long term care typically include these risk factors: history of falling, use of ambulatory aids, gait/balance issues, medications, secondary diagnoses (i.e. diabetes) and mental status. Care planning is the next step in nursing care - it is the standard of care that as the resident’s status changes, assessments and care plans must be updated, and often, are not. For example, with each fall, there should be updates, or if there is a new diagnosis, i.e. stroke, or worsening dementia, updated interventions should be put into place, with ongoing evaluation of effectiveness.

Care planning and interventions very often are generic and not individualized. For example, a toileting schedule that includes only after meals and before bedtime may not be appropriate. If a resident has issues with constipation or incontinence, this may lead to the need for more frequent toileting to prevent falls. The “make certain call bell is within reach” for residents with dementia is an example of a generic intervention. Older adults with dementia may not recognize a call bell or remember to use it. The debate about use of bed and chair alarms go on – they are a part of an individualized care plan, not a solution to preventing falls. Often, I see delays in putting interventions in place, i.e. with the resident who is incontinent NOT being put on a toileting plan immediately. The other common issue I see when reviewing records is the lack of updating care plans as the resident’s status changes – with every fall, with worsening dementia, physical decline, or new medical diagnosis (i.e. Parkinsonism).

Nurses reviewing records need to pay attention to the MDS, risk assessments, care plans and Interdisciplinary notes with attention to where the standard of care is not being met.
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6 days ago  ·  

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