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Thursday, January 18, 2018

RECALLS

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Levofloxacin in 5% Dextrose 250mg/50mL
AuroMedics Pharma LLC is voluntarily recalling one lot of Levofloxacin in 5% Dextrose Injection 250mg/50mL in a Single-Use flexible container NDC 55150-243-46, Lot CLF160003, Expiry date May 2018, to the hospital level. The product has been found to contain visible particulate matter tentatively identified as mold. This problem was discovered as a result of a product complaint in which the contents of one flexible bag was found to contain white particulate matter.

Risk Statement: Use of a non-sterile injectable product could result in fatal infections in a broad array of patients. To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to this recall.

Levofloxacin injection is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the specified conditions

Palmer Candy Company Announces Voluntary Recall of Sea Salt Caramel Hearts
Palmer Candy Company (www.palmercandy.com), announced today a limited recall of Sea Salt Caramel Hearts that were only sold at Bomgaards Supply Inc. Store in the Midwest States. The voluntary recall, in cooperation with the U.S. Food and Drug Administration (FDA) due to abundance of caution of a possible peanut allergen contamination. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

The issue was discovered by Palmer Candy Team Members. During the packing process a peanut was observed stuck to the outside of the Sea Salt Caramel Heart. To date no complaints of illness or injury have been reported to Palmer Candy.

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