FDA Recalls For May 16, 2012

Recalls reported by FDA for OTC drugs, nutritionals and personal care products.

DIETARY SUPPLEMENT - CLASS I
1) Mince Belle Dietary Supplement, 30 capsules; 2) Perfect Men Dietary Supplement, 10 capsules; 3) EVERLAX Dietary Supplement, 30 capsules; 4) EVER Slim Dietary Supplement, 30 capsules; 5) Herbal Drink Acai-man mangosteen Dietary Supplement, contents 16.6 fl oz; 6) EVER SLIM Shake Mix Dietary Supplement Strawberry, net weight 17.6 oz; 7) EVER SLIM Shake Mix Dietary Supplement Chocolate, net weight 17.6 oz.
Code: 1) Lot #: HPCMB/10-026, HPCMB/10-027, HPCMB/10-029, HPCMB/10-020, HPCMB/10-021, and HPCMB/10-016; 2) Lot #: HPCPM/002; 3) Lot #: HPCEX/074, HPCEX/076, HPCEX/072, and HPCEX/032; 4) Lot #: HPCES-079, HPCES-070, HPCES-071, and HPCES/038; 5) Lot #: HPJAC/004; 6) Lot #: HPESSF/168; 7) Lot #: HPESSC/061
Manufacturer:	Healthy Labs S. de R. L. de C. V., Irapuato, Mexico
Recalled by:	Healthy People, Irwindale, CA, by press release on Feb. 3, 2012. Firm-initiated recall is ongoing.
Distribution:	Nationwide; 771 boxes (14,251 units)
Reason:	Marketed without an approved NDA/ANDA: FDA laboratory analyses found the products to contain sibutramine, an appetite suppressant that was withdrawn from the market in October 2010 for safety reasons, making these products unapproved new drugs.
Recall numbers:	D-1347-2012D-1348-2012D-1349-2012; D-1350-2012;D-1351-2012;D-1352-2012; D-1353-2012
DRUGS - CLASS III
Advil Liqui-Gels 200 mg (ibuprofen), 40 count, 40+20 count and 240 count bottles.
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
Manufacturer:	Catalent Argentina S.A.I.C., Villa Loma Hermosa, Argentina.
Recalled by:	Pfizer Inc., New York, NY, by letter on March 16, 2012. Firm-initiated recall is ongoing.
Distribution:	Nationwide; 653,162 units
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.
Recall numbers:	D-1337-2012
COSMETICS - CLASS III
"***H***GENTLE***EYE MAKEUP***REMOVER***HYDRON***Detergent Free***Mineral Oil Free*** Fragrance Free***4 fl. oz., 118 ml***Bi-phase formula hydrates and conditions delicate skin and lashes***Mild cleansing agents dissolve even waterproof mascara***pH buffered to match tear fluid***Dermatologist and ophthalmologist tested. Safe for contact lens wearers***TO USE: Shake vigorously before application. Moisten cotton pad and wipe gently across eyelid. Rinse with plain water and pat dry.*** INGREDIENTS: Purified Water, Cyclomethicone, Isohexadecane, Hexylene Glycol, Polaxamer 184, Dipotassium Phosphate, Sodium Chloride, Benzyl Alcohol, Potassium Phosphate, Quaternium-15, Disodium EDTA, FD&C Green No .3***".
Code: Lot # BRX10D132
Manufacturer:	Brand Builders Rx LLC, Saint Petersburg, FL
Recalled by:	Brand Builders Rx LLC, by letter dated June 10, 2010. FDA-initiated recall is ongoing.
Distribution:	Nationwide; 188
Reason:	The FD&C Green #3 is prohibited for use on areas of the eye.
Recall numbers:	F-1199-2012
EDITORS’ NOTE: Tabulation prepared from information provided by FDA. The agency has three classes of recalls. Class I - violative product poses reasonable probability of serious adverse health consequences or death; Class II - violative product may cause temporary or medically reversible adverse health consequences; probability of serious consequences remote; Class III - violative product not likely to cause adverse health consequences.