|
SafetyAlerts
May 21, 2003
Watson Diagnostics Has Recalled Nicotine Polacrilex
Gum
Note:
Nicotine gum
recall includes many store brands.
The Food and Drug Administration (FDA)
released the following information.
PRODUCT
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.
CODE
Lot numbers: 4NG02021-Exp Date 07/01/2004;
4NL02133-Exp Date 11/01/2004.
RECALLING FIRM/MANUFACTURER
Watson Diagnostics, Inc., Corona, CA, by letter dated April 7, 2003.
Firm initiated recall is ongoing.
REASON
Contamination: pieces of latex gloves were found in the gum.
VOLUME OF PRODUCT IN COMMERCE
19,853 cartons (total for both lots).
DISTRIBUTION
Nationwide.
|
