Recall-Advil Liqui-Gels

--No safety concerns were associated with the recall

Advil Liqui-Gels. Photographer:
Scott Olson/Getty Images

By Peter Loftus 
   Of DOW JONES NEWSWIRES 
 

Pfizer Inc. (PFE) recently recalled more than 650,000 bottles of Advil pain-relief medicine due to the potential for a strong odor in the product.

New York-based Pfizer issued the voluntary recall of eight lots of Advil Liqui-Gels bottles in March to retail-distribution centers only, spokeswoman Jenifer Antonacci said Friday. The recall wasn't at the consumer level, she said.

The Advil recall was issued because an element of the manufacturing process "may have caused a stronger odor in the product," according to a notice posted this week on the U.S. Food and Drug Administration's website.

"We were able to isolate the issue and took corrective action," said Antonacci. No safety or adverse-event concerns were associated with the recall.

The recalled product was manufactured by contract manufacturer Catalent Argentina S.A.I.C. in Argentina, according to the FDA website. A Catalent spokeswoman couldn't immediately be reached.
Unaffected lots of Advil Liqui-Gels remain available in stores, Antonacci said.

In 2010, as rival Johnson & Johnson (JNJ) was grappling with a series of recalls for over-the-counter medicines including Tylenol, Pfizer launched a marketing campaign urging consumers to clean out medicine cabinets and dispose of recalled and expired products, and offered coupons for free Advil.
Last year, Pfizer recalled more than 315,000 packages of Advil Congestion Relief tablets because the product failed to meet dissolution specifications, according to the FDA website.

More information about the Advil recall, including affected lot numbers, can be found at the FDA's website: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm304512.htm?source=govdelivery.

-By Peter Loftus, Dow Jones Newswires; +1-215-982-5581; peter.loftus@dowjones.com

FDA Enforcement Report for May 16, 2012
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
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PRODUCT

Advil Liqui-Gels 200 mg (ibuprofen), 40 count, 40+20 count and 240 count bottles. Recall # D-1337-2012

CODE

Lot # Exp Date: F48768 02/2013; F71099 03/2013; F74724 03/2013; 42281 03/2013; 42284 03/2013; 42285 03/2013; 42288 03/2013; 42291 03/2013; 1355CB 03/2013; 1712FR 03/2013;1412RR 03/2013 ; 1612RR 03/2013; 2010KA 03/2013 ; 1362KA 03/2013; 1361KA 03/2013 ; 1712AR 03/2013; 1612AR 03/2013 ; 1112CRA 03/2013; 1812AR 03/2013; 1212CR 03/2013; 1112CR 03/2013; 2005HA 03/2013; 2053DA 03/2013

RECALLING FIRM/MANUFACTURER

Recalling Firm: Pfizer Inc., New York, NY, by letter on March 16, 2012.

Manufacturer: Catalent Argentina S.A.I.C., Villa Loma Hermosa, Argentina. Firm initiated recall is ongoing.

 

REASON

CGMP deviation; enzymatic hydrolysis time for the gelatin manufacturing process of these lots was increased which may have caused a stronger odor of the product.

VOLUME OF PRODUCT IN COMMERCE

653,162 units

DISTRIBUTION

Nationwide