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FDA Mediation Watch: Valproate Anti-Seizure Products: Drug Safety Communication – Contraindicated for Pregnant Women for Prevention of Migraine Headaches

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

Based on a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant. MedWatch Safety Alert RSS Feed

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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 New Drugs Feed: FDA Drug Safety Communication: FDA approves label changes for zolpidem products, including new dosing and a recommendation to avoid driving the day after Ambien CR use

By fdanews on Tuesday, May 14th, 2013 | No Comments

The U.S. Food and Drug Administration (FDA) is notifying the public that FDA has approved label changes specifying new dosing recommendations for zolpidem products (Ambien, Ambien CR, and Edluar), which are widely prescribed sleep medications. What’s New: Drugs RSS Feed

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FDA Recall Alerts: Hannaford Supermarkets Issues Allergy Alert for Two Bakery Cookie Products That May Contain Undeclared Nuts

By fdanews on Monday, May 13th, 2013 | No Comments

Hannaford Supermarkets is recalling two products sold in the bakery section because they may contain nuts that are not listed on the product packaging label. Individuals who have an allergy or severe sensitivity to any nuts may run the risk of serious or life-threatening allergic reaction should they consume these items. Food and Drug Administration–Recalls/Safety [...]

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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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