May 21, 2003
Watson Diagnostics Has Recalled
Nicotine Polacrilex Gum
The Food and Drug Administration (FDA) released the following information.
Nicotine Polacrilex Gum USP, 4 mg (Active ingredient (in each piece) 4 mg
nicotine), STARTER KITS (each
carton contains 108 Chewing Pieces in blister packs) and REFILL KITS (each
carton contains 48 Chewing
Pieces in blister packs)--- Distributed under the following private
labeling: ----CVS pharmacy brand,
POLACRILEX GUM USP, NICOTINE 4 mg, ORIGINAL, ---- Rugby brand, nicotine
polacrilex gum, USP, 4 mg
(nicotine, ---- Walgreens brand, Nicotine Gum 4 mg, nicotine polacrilex, USP,
--- LEADER brand, Nicotine
Gum, Nicotine Polacrilex Gum USP, 4 mg (nicotine).
Recall # D-225-3.
Lot numbers: 4NG02021-Exp Date 07/01/2004;
4NL02133-Exp Date 11/01/2004.
Watson Diagnostics, Inc., Corona, CA, by letter dated April 7, 2003. Firm
initiated recall is ongoing.
Contamination: pieces of latex gloves were found in the gum.
VOLUME OF PRODUCT IN COMMERCE
19,853 cartons (total for both lots).