02.19.08
Posted in recalls, therapy products at 8:47 am by Suthin Liptawat
This is another FDA Alert presented by Suthin Liptawat, M.D.
Chattem, Inc. and FDA informed consumers and healthcare professionals of a voluntary nationwide recall of its Icy Hot Heat Therapy products, including consumer “samples” that were included on a limited promotional basis in cartons of its 3 oz Aspercreme product. The products were recalled because of consumer reports of first, second and third degree burns as well as skin irritation. All lots and sizes of the following Icy Hot Heat Therapy products were recalled:
Icy Hot Heat Therapy Air Activated Heat - Back
Icy Hot Heat Therapy Air Activated Heat - Arm, Neck, and Leg
Icy Hot Heat Therapy Air Activated Heal - Arm, Neck, and Leg single consumer use “samples” on a limited promotional basis in cartons of 3 oz. Aspercreme Pain Relieving Cream.
Consumers who have the Icy Hot Heat Therapy products under this recall should immediately stop using the products, discard them, and /or return them to the manufacturer.
[February 08, 2008 - Press Release - Chattem, Inc.]
Popularity: 22% [?]
Permalink
02.18.08
Posted in recalls at 12:47 am by Suthin Liptawat
PriCara and Sandoz Inc. announced a nationwide recall of all lots of 25 mcg/hr Duragesic Patches sold in the United States. The product is being recalled because the patches may have a cut along one side of the drug reservoir within the patch which may result in the possible release of fentanyl gel that may expose patients or caregivers directly to fentanyl gel on the skin. Fentanyl is a potent Schedule II opioid medication and exposure to the gel may lead to serious adverse events, including respiratory depression and possible overdose, that may be fatal. Patches with a cut edge should not be used. These recalled patches have expiration dates on or before December 2009 and are all manufactured by ALZA Corporation.
Read the complete 2008 MedWatch Safety Summary, including a link to the FDA Firm Press Release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Duragesic
Popularity: 21% [?]
Permalink
02.11.08
Posted in eyes / ears wash products, recalls at 5:14 am by Suthin Liptawat
Recall — Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Nationwide Recall of NuCel Labs Eye Drops and Eye/Ear Wash Products
Contact:
Kevin Lundquist
208-542-0325
FOR IMMEDIATE RELEASE — January 29, 2008 — NuCel Labs of Idaho Falls, Idaho announced today that it is conducting a voluntary nationwide recall of all Eye Drops and Eye/Ear Wash. This recall follows an FDA inspection in which product testing indicated that there was bacteria and particulate matter in the product deeming these products non-sterile. Non-sterile eye drops pose an unacceptable risk of causing eye infections, which in rare cases could lead to blindness.
Products are packaged in 1/4 oz plastic bottles. Eye drops are labeled: Eye Drops Caution: Do Not Use With Implants. Wash is labeled Eye/Ear Wash. All products labeled “Eye Drops Caution: Do Not Use With Implants” or “Eye/Ear Wash” are subject to the recall action. There are no lot numbers or expiration dates on the product. Approximately 500 units of these products have been distributed nationwide through retail outlets and the internet.
No illnesses or injuries have been reported to date.
The company has ceased the production and distribution of the product. Consumers who may have any of these products on hand are advised not to use them. Consumers are asked to return them to NuCel Lab, 1380 Curtis Ave, Idaho Falls, Idaho 83402 or discard them and send NuCel Lab a purchase receipt for a full refund. Consumers with questions may call NuCel Lab at 208-542-0325.
As a subscriber to FDA Alerts newsletter, I am spreading this warning.
Suthin Liptawat,M.D.
Popularity: 34% [?]
Permalink