Pharmacy Services
Acetaminophen Concentrated Drops - Brookstone Pharmaceuticals Voluntary Recall Due to Packaging Concerns
July 16, 2009
Brookstone Pharmaceuticals initiated a voluntary recall of all lots of concentrated acetaminophen drops (80 mg/0.8mL) in the 473 mL package size. The recalled drops are packaged without an integrated dosing device and are in a similar presentation as regular strength acetaminophen solution (160mg/5mL). This packaging raises concerns about possible product confusion and the potential for overdose. Acetaminophen overdoses can be fatal or life-threatening and cause significant liver and kidney damage. Discontinue use of this product immediately. For further questions or information on returning product, contact Brookstone Pharmaceuticals at 1-800-541-4802, option 2. This recall comes in response to a FDA advisory panel recommendation to use a single strength of children’s acetaminophen liquid.
Additional information may be found at the following links:
- Medwatch Safety Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm172252.htm - Press Release with Lot Number and UPC Information:
http://www.fda.gov/Safety/Recalls/ucm171780.htm - Final Rule for Additional Labeling for OTC Pain Relievers and Fever Reducers
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149573.htm
http://edocket.access.gpo.gov/2009/pdf/E9-9684.pdf
http://www.fda.gov/Drugs/NewsEvents/ucm144068.htm - Related Link
http://healthcare.utah.edu/pharmacy/alerts/388.htm
Updated
July 16, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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