Pfizer Recalls 653,000 Bottles of Advil After CGMP Deficiencies Cause 'Strong Odor'
Posted 21 May 2012 | By
New York-based pharmaceutical manufacturer Pfizer has recalled more than 653,000 bottles of its Advil Liqui-Gels pain-reliever after becoming aware of a "strong odor" in the product, reports Dow Jones Business Wire.
The products, composed of eight lots manufactured at an Argentina-based facility operated by contract manufacturing organization (CMO) Catalent Argentina S.A.I.C., were recalled from retail-distribution centers in March, according to a US Food and Drug Administration (FDA) enforcement report released 16 May 2012.
The products reportedly did not meet current good manufacturing practice specifications after being exposed to enzymatic hydrolysis for an incorrect amount of time, which in turn "caused a stronger odor" in the product, wrote FDA.
In a statement to the Dow Jones Newswire, Pfizer spokeswoman Jenifer Antonacci said the lots had been recalled and the issue isolated and corrected.
Dow Jones Newswire - Pfizer Recalls More Than 650,000 Bottles Of Advil Liqui-Gels
FDA Enforcement Report - Advil Liqui-Gels 200 mg (ibuprofen), 40 count, 40+20 count and 240 count bottles. Recall # D-1337-2012