SmithFoods Inc. Issues Allergy Alert on Undeclared Cashew Allergen in Earth Grown Vegan Non Dairy Almond Based Frozen Desserts

Summary Company Announcement Date: July 31, 2020
FDA Publish Date: July 31, 2020
Product Type: Food & Beverages Ice Cream/Frozen Dairy Allergens Reason for Announcement: Recall Reason Description Undeclared cashew
Company Name: SmithFoods Inc. Brand Name: Brand Name(s) Earth Grown
Product Description: Product Description Vegan Non-Dairy Almond Based Frozen Desserts
Company Announcement SmithFoods Inc. announced that it is voluntarily recalling 16-oz pint packages of Earth Grown Vegan Non-Dairy Almond Based Frozen Desserts because it may contain an undeclared cashew allergen. People who have an allergy or severe sensitivity to cashews run the risk of a serious or life-threatening allergic…

FRONTLINE HAND SANITIZER WIPES (ethyl alcohol) cloth [DINAMO KOZMETIK VE TEKSTIL DIS TICARET ANONIM SIRKETI]

Warnings : For external use only. Flammable.

Keep away from heat or flame

Do not use

• in children less than 2 months of age
• on open skin wounds

When using this product : Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor : If irritation or rash occurs. These may be signs of a serious condition

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

ATOMOXETINE capsule [American Health Packaging]

8432625/0520

Atomoxetine Capsules, USP
(a” toe mox’ e teen)

Read the Medication Guide that comes with atomoxetine capsules before you or your child starts taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your treatment or your child’s treatment with atomoxetine capsules.

What is the most important information I should know about atomoxetine capsules?
The following have been reported with use of atomoxetine capsules:

1. Suicidal thoughts and actions in children and teenagers:
Children and teenagers sometimes think about suicide, and many report trying to kill themselves. Results from atomoxetine capsules clinical studies with over 2200 child or teenage ADHD patients suggest that some children and teenagers…

ETHAMBUTOL HYDROCHLORIDE tablet, film coated [Epic Pharma, LLC]

Ethambutol hydrochloride may produce decreases in visual acuity, including irreversible blindness, which appear to be due to optic neuritis. Optic neuropathy including optic neuritis or retrobulbar neuritis occurring in association with ethambutol therapy may be characterized by one or more of the following events: decreased visual acuity, scotoma, color blindness, and/or visual defect. These events have also been reported in the absence of a diagnosis of optic or retrobulbar neuritis.
Patients should be advised to report promptly to their physician any change in visual acuity.
The change in visual acuity may be unilateral or bilateral and hence each eye must be tested separately and both eyes tested together. Testing of visual acuity should be performed before beginning ethambutol hydrochloride therapy and periodically…

WESTAB PLUS (vitamin a acetate, beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, and cupric oxide) tablet [Westminster Pharmaceuticals, LLC]

Other Ingredients: Microcrystalline Cellulose, Stearic Acid, Sodium Starch Glycolate, Silicon Dioxide, Magnesium Stearate, Coating (Hydroxypropylmethylcellulose, Polyethylene Glycol, Propylene Glycol, Triacetin, Titanium Dioxide, FD&C Yellow #5, FD&C Yellow #6, FD&C Blue #2). …

SUNMARK SALINE SINGLE LAXATIVE (sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form) enema [Strategic Sourcing Services LLC]

SUNMARK SALINE SINGLE LAXATIVE- sodium phosphate, dibasic and sodium phosphate, monobasic, unspecified form enema To receive this label RSS feed Copy the URL below and paste it into your RSS Reader application. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=06720229-7d58-499e-b7de-cb4bda5ae416 To receive all DailyMed Updates for the last seven days Copy the URL below and paste it into your RSS Reader application. https://dailymed.nlm.nih.gov/dailymed/rss.cfm What will I get with the DailyMed RSS feed? DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. To view updated drug label links, paste the RSS feed address…

CLONIDINE HYDROCHLORIDE tablet [Aphena Pharma Solutions – Tennessee, LLC]

Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100.
The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride tablets USP, but in many cases patients were receiving concomitant medication and a causal relationship has not been established.

Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome. Also reported were a weakly positive Coombs’ test and increased sensitivity to alcohol.

Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree…

AMERICAN BLING PROTECTIVE DISINFECTING WIPES (alcohol) cloth [Zhejiang iColor Biotech Co., Ltd]

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages? Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. …

FOLLOW THE RAINBOW ANTIBACTERIAL HAND SANITIZER COCONUT MILK SCENTED (alcohol) gel [Ganzhou Olivee Cosmetic Co., Ltd.]

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages? Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. …