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FDA Recall Alerts: Sandoz US Announces Voluntary Nationwide Recall of two lots of Methotrexate Sodium, USP, Injectable Vials, 25mg/mL, 40mL vials

By fdanews on Thursday, May 23rd, 2013 | No Comments

Sandoz is conducting a voluntary nationwide recall to the hospital/user level of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the US, due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer. The product is preservative free. Food and [...]

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FDA Recall Alerts: Pentec Health Announces Limited Voluntary Recall of Certain Compounded Prescription Therapies for Renal Patients

By fdanews on Friday, May 17th, 2013 | No Comments

Pentec Health, Inc. has decided to initiate a limited, voluntary recall of in-date nutritional prescriptions for renal patients due to lack of sterility assurance associated with one of its laminar flow hoods used in compounding. The recall covers renal therapies that were compounded in this hood on or before May 2, 2013. Food and Drug [...]

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FDA Recall Alerts: Dairy Fresh Conducts Voluntary Recall of IGA Brand “Vanilla & Chocolate” 1.75 Quart Ice Cream Because Package May Contain Undeclared Allergens (Almonds, Coconut, Soy)

By fdanews on Thursday, May 16th, 2013 | No Comments

Dairy Fresh is voluntarily recalling a specific batch of IGA Brand “Vanilla & Chocolate” Ice Cream (1.75 quart, 1.66L) with the plant code “3783” and a SELL BY date of 08-13-13 because it incorrectly contains Heavenly Hash ice cream, which contains almonds, coconut, and soy, which are allergens not declared on the carton. People who [...]

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FDA Recall Alerts: In Cooperation with FDA, The Compounding Shop, LLC Declares a Voluntary Recall of All Lots of Sterile Compounded Products Due to a Lack of Sterility Assurance Distributed Within its Local Market Area

By fdanews on Wednesday, May 15th, 2013 | No Comments

The Compounding Shop, LLC is conducting a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired. The recall is being initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. Food and Drug [...]

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FDA Recall Alerts: Beamonstar Products Issues Voluntary Nationwide Recall of SexVoltz, Velextra, & Amerect Marketed as a Dietary Supplement, Due to Undeclared Active Ingredients- Expanded to Include SexVoltz 12 Capsules Bottle, SKU 626570615316.

By fdanews on Sunday, May 12th, 2013 | No Comments

Queen Creek, AZ, BeaMonstar Products is voluntarily recalling all of SexVoltz brand SKU’s 626570609490, 827912089028, 626570617877, 626570615316, 626570615316 Velextra brand SKU’s 626570613855, 626570619055, 626570617860, 626570617563 Amerect SKU’s 626570619031, 626570619628 capsules to the consumer level. Laboratory analysis conducted by the FDA on SexVoltz and Velextra has determined these products contain undeclared tadalafil. Amerect is voluntarily recalled [...]

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