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FDA MedWatch Safety Alerts: December 2009

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Recommendations:

  • If you have unexpected side effects from sexual enhancement products, contact your health care professional.
  • Stop using the recalled products and return them to the place of purchase. You may also return products directly to Atlas Operations for a refund; call 800-466-4444 for instructions.

Recall: Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels

Bayer has recalled one product lot of the combination package of Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels. The labeling on the foil blister card of certain packages within the lot was printed with the label reversed. The product was sold at retail outlets throughout the United States.

The details of the recalled Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels are as follows:

  • Package size: 20 liquid filled capsules per carton (12 day formulation capsules and 8 night formulation capsules)
  • UPC#: 016500537779
  • Lot #: 296939L
  • Expiration: 5/11

You can find the product lot number on both the interior blister package (in black text next to the expiration date) and the exterior carton containing the blister packaging (embossed on the side panel under the Bayer company logo).

The risk: The label for the green night product appears under some of the blue day product and vice versa. Consumers using the affected product may not be aware of the warnings regarding an antihistamine in the product that could cause drowsiness.

Recommendations:

  • Stop using the recalled product.
  • Contact your health care professional if you have a medical concern.
  • Contact Bayer Consumer Care at 800-986-3307 with any other questions or for instructions on a refund or replacement.

Recall: Thermoflect Products

Encompass Group has recalled its Thermoflect product line for relabeling regarding its use with magnetic resonance (MR).

FDA has recommended that Thermoflect blankets and other Thermoflect products not be used for patients undergoing magnetic resonance imaging (MRI), a technology that uses the body’s natural magnetic properties to produce detailed images of parts of the body.

In addition to being used in hospitals and by the military, Thermoflect products may be used by consumers for camping or other outdoor activities because they can help prevent dangerously low body temperature (hypothermia). In addition to blankets, Thermoflect products include jackets, pants, vests, and caps for adults and children.