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View Full Version : FDA Alert:Incorrect packaging,Alka-Seltzer Plus® Day & Night Cold Formula Liquid Gels



Dr.Deepak
12-10-2009, 03:55 AM
Morristown, NJ. - December 8, 2009 - In consultation with the U.S. Food and Drug Administration (FDA), Bayer’s Consumer Care division has begun a voluntary recall of a single product lot of the combination package of Alka-Seltzer Plus® Day & Night Cold Formula Liquid Gels. Bayer initiated the recall after identifying that the labeling on the foil blister card of certain packages within the lot (less than 4 percent) were printed with the label reversed. All individual liquid filled capsules are imprinted correctly.

The affected Alka-Seltzer Plus product lot number can be found on both the interior blister package (in black text adjacent to the expiration date) as well as on the exterior carton containing the blister packaging (embossed on the side panel under the Bayer logo)

Product Name: Alka-Seltzer Plus Day & Night Liquid Gels
Package size: 20 liquid filled capsules per carton (12 day formulation capsules and 8 night formulation capsules)
UPC#: 016500537779
Lot #: 296939L
Expiration: 5/11
This product was sold only in the U.S. at retail outlets nationwide.

This recall does not impact any Alka-Seltzer Plus Day & Night Cold Formula Effervescent products, individually packaged Alka-Seltzer Plus Day Non-Drowsy Cold Formula products, individually packaged Alka-Seltzer Plus Night Cold Formula products, or any other lot of Alka-Seltzer Plus Day & Night Cold Formula Liquid-Gels.

The company initiated an investigation following consumer reports and found that in a limited number of combination packages of Alka-Seltzer Plus Day and Night Cold Formula Liquid Gels from a single lot, the information on the underside of the blister package was reversed. Therefore, the label for the green Night product appears under some of the blue Day product and vice versa. As such, there is a risk that consumers may not be aware of the warnings of an antihistamine in the product that could cause drowsiness.

Consumers who purchased combination packages of Alka-Seltzer Plus Day and Night Cold Formula Liquid Gels from the lot included in this recall (details below) should stop using the product and contact Bayer with any questions or for instructions on a refund or replacement. Consumers should contact our Consumer Relations Call Center at 1(800) 986-3307 (available Monday - Friday 8:30 AM - 5:30PM eastern standard time.) Any consumer with a medical concern or questions should contact their healthcare provider.

More :http://www.fda.gov/Safety/Recalls/ucm193409.htm