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RX ALERTS/CONSUMER ALERTS

OLD GLORY’S EAGLE

070-2017, OFD Food, LLC. Recalls Beef Products Due to Possible Foreign Matter Contamination (Jun 13, 2017)

You may view a copy of the updated information.

WASHINGTON, June 13, 2017 – OFD Foods, LLC., an Albany, Ore. establishment, is recalling approximately 197 pounds of beef product that may be contaminated with extraneous materials, specifically rubber, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The beef hash item was produced on Dec. 22, 2016. The following product is subject to recall: [View Labels (PDF Only)]

  • 3.88-oz. pouch of “MOUNTAIN HOUSE FREEZE DRIED SPICY SOUTHWEST BREAKFAST HASH,” with pouch code 3253174 and best by date of Dec. 2046.
  • Mountain House label pdf view

WASHINGTON, Aug. 7, 2017 – Good Food Concepts, LLC., a Colorado Springs, Colo. establishment, is recalling approximately 1,290 pounds of raw intact and non-intact beef because the products may be contaminated with E. coli O26, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

view here

The raw intact and non-intact beef items were processed and packaged on Aug. 3 and Aug. 4, 2017. The following products are subject to recall: [View Labels (PDF Only)]


WASHINGTON, July 24, 2017 – Stefano’s Foods, Inc., a Charlotte, N.C. establishment, is recalling approximately 981 pounds of Stromboli products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains eggs, a known allergen which is not declared on the product label.  view here

The frozen meatball Stromboli items, produced on June 24, 2017, were incorrectly packaged in a box labeled as pepperoni and Italian sausage Stromboli. The following product is subject to recall: [View Label (PDF Only)]


Voluntary Nationwide Recall of all Liquid Products Manufactured by Pharmatech LLC and Distributed by Leader Brand, Major Pharmaceuticals, and Rugby Laboratories Due to Possible Product Contamination VIEW HERE

Patients, pharmacies, and healthcare facilities that have the recalled product on hand should stop using and dispensing them immediately.

Consumers with questions regarding this recall can contact the companies at the numbers below:

•Leader Customer Support: at 1-800-200-6313, option #1, Monday through Thursday 8 a.m. – 7p.m. and Friday 8 a.m.– 5 p.m. EST

•Rugby Laboratories/Major Pharmaceuticals Customer Support: 1-800-645-2158, Monday through Friday 8 a.m. – 8 p.m. EST


Pravastatin Sodium Tablets by International Laboratories: Recall – Mislabeling

AUDIENCE: Pharmacy, Patient

ISSUE: International Laboratories, LLC is voluntarily recalling one (1) Lot of Pravastatin Sodium Tablets USP 40 mg packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg tablets. The affected product is NDC# 54458-925-16; Lot# 115698A

This lot of Pravastatin Sodium Tablets USP 40 mg was recalled when International Laboratories, LLC was informed by a pharmacist that one 30ct bottle of this product was mislabeled and contained Bupropion Hydrochloride XL 300 mg tablets.

If a subject mistakenly takes bupropion, common side effects include: nausea, vomiting, dry mouth, headache, constipation, sweating, sore throat, diarrhea, dizziness, restlessness, blurry vision. These are typically minor and reversible issues. However, individuals with epilepsy are at higher risk of seizure on bupropion due to it lowering the seizure threshold. Also, people on MAOIs can have a risky drug interaction with bupropion (hypertensive crisis). Finally, allergic reactions are also possible and could be life threatening.

BACKGROUND: Pravastatin Sodium Tablets USP 40 mg are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate. It is used to treat children and adolescent patients ages 8 years and older with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy.

Bupropion hydrochloride extended-release tablets (XL) 300 mg are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD) in children, adolescents, young adults and adults.

RECOMMENDATION: International Laboratories, LLC is notifying its distributors and customer by letter and is arranging for return of all recalled products.  Consumers who have purchased this product should not open the package or use the contents. Instead, they should return the product to the location of purchase for a full refund, or call a Customer Complaint phone number at International Laboratories, LLC 727-322-7146 (MondayFriday 8 AM – 5 PM EST).

Consumers with questions regarding this recall can contact International Laboratories, LLC by phone 727-322-7146 or e-mail address sutka.veselinovic@internationallabs.com on MondayFriday 8AM – 5PM EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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:

Read the MedWatch safety alert, including a link to the press release, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm571066.htm


 

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Posted in 2017, ALERT, ALERTS, AMERICA, FDA, Signs of the Times
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