drugs Class I Updated 2013-05-22

InSo-Independent Contractor for West Coast Nutritionals,LTD recalls a) Firminite 805 mg is packaged in 2 count, 4 count, and 10

Recalled Product

a) Firminite 805 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.FIRMINITE.COM, b) Libidron 410 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.LIBIDRON.COM , c)Extra Strength Instant Hot Rod 496 mg is packaged in 4 count and 10 count capsule blister packs in a box, www.HotRodExtraStrength.com

Hazard / Issue

Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots
View official government recall

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