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McNeil Recalls Single Lot of Tylenol Extra Strength Caplets, 225 count
McNeil Consumer Healthcare is recalling one lot of Tylenol, Extra Strength Caplets, 225 count bottles, distributed in the U.S. This recall is being issued because of a small number complaints of musty, moldy odor. The uncharacteristic musty, moldy smell has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA).
This voluntary action is being taken as a precaution and the risk of serious adverse medical events is very rare. TBA can generate an offensive odor and has been associated with temporary and non-serious gastrointestinal symptoms including nausea, stomach pain, vomiting, or diarrhea.
The recall is for Tylenol Extra Strength Caplets, 225 count, lot number ABA619. The lot number can be found on the side of the bottle label. Tylenol contains the active ingredient acetaminophen. No other acetaminophen products were involved in this recall.
For more information, please visit:
http://www.tylenol.com/page2.jhtml?id=tylenol/news/subp_tylenol_recall_6.inc
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Qualitest Recalls Four Lots of Butalbital, Acetaminophen, and Caffeine Tablets and Four Lots of Hydrocodone Bitartrate and Acetaminophen Tablets
Qualitest Pharmaceuticals has issued a voluntary nationwide recall of Butalbital, Acetaminophen, and Caffeine Tablets, 50mg/325mg/40mg, and Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5mg/500mg. The lots are being recalled because an individual bottle of Butalbital, Acetaminophen, and Caffeine Tablets, 50mg/325mg/40mg, 500 count was found incorrectly labeled with a Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5mg/500mg, 1000 count label.
The following lots are being recalled:
Butalbital, Acetaminophen, and Caffeine Tablets, USP, 50mg/325mg/40mg, NDC 0603-2544-28 500 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg / 500mg, NDC 0603-3882-32, 1000 count, Lot Numbers C0390909A, C0400909A, C0410909A, C0590909B
This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration.
Butalbital, Acetaminophen, and Caffeine is used to treat migraines. These combination tablets are made by many different manufacturers and are sold under other names including Esgic-Plus and Fioricet. Hydrocodone Bitartrate and Acetaminophen is used for moderate to severe pain. These combination tablets are made by many different manufacturers and are also sold under other names such as Anexsia, Co-Gesic, Lortab, Norco, and Vicodin.
This recall alert only applies to the select lots of the generic Butalbital, Acetaminophen, and Caffeine Tablets, 50mg/325mg/40mg and Hydrocodone Bitartrate and Acetaminophen Tablets, 10mg / 500mg from Qualitest. No other Butalbital, Acetaminophen, and Caffeine or Hydrocodone Bitartrate and Acetaminophen products are involved in this recall.
For more information, please visit:
http://www.fda.gov/Safety/Recalls/ucm260837.htm
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