DECEMBER 2002

WEEK ENDING DECEMBER 7

PRODUCT Lunelle Monthly Contraceptive Injection (medroxyprogesterone acetate 25mg and estradiol cypionate 5mg) Injectable Suspension, Single Use 0.5 mL syringe and physician samples, For Intramuscular Use Only, Rx only.

CODE All lots distributed in 2002.

RECALLING FIRM/MANUFACTURER Recalling Firm: Pharmacia Corporation, Kalamazoo, MI.

Manufacturer: Pharmacia Corporation, Puurs, Belgium.

REASON Subpotency; the active ingredients.

VOLUME OF PRODUCT IN COMMERCE 800,000 units.

DISTRIBUTION Nationwide.

PRODUCT a) Oral Saline Laxative (Monobasic sodium phosphate 2.4g and Dibasic sodium phosphate 0.9g), Eckerd brand, 3 Fl. oz. (90mL) multi-dose container, Lemon Flavor, Sugar Free;

b) Oral Saline Laxative (Monobasic sodium phosphate 2.4g and Dibasic sodium phosphate 0.9g), Family Pharmacy brand, 3 Fl. oz. (90mL) multi-dose container, Lemon Flavor, Sugar Free.

CODE 1263L exp. 9/03, 1267L exp. 9/03 and 1281L exp. 10/03.

RECALLING FIRM/MANUFACTURER Unico Holdings, Inc., Lake Worth, FL

REASON Superpotent; active ingredients Monobasic and Dibasic Sodium Phosphate.

VOLUME OF PRODUCT IN COMMERCE

Lot 1263L 935/12/3 oz cases,

Lot 1267L 432/12/3 oz cases,

Lot 1281L 447/12/3 oz cases.

DISTRIBUTION Nationwide.

PRODUCT Novolin 70/30 InnoLet, 70% NPH, Human Insulin Isophane Suspension and 30% Regular, Human Insulin Injection (rDNA origin), 100 units/mL, 3mL Prefilled Insulin Syringes, Novo Nordisk.

CODE Lot # MS 60812 Exp. 6/2004

RECALLING FIRM/MANUFACTURER Recalling Firm: Novo Nordisk Pharmaceuticals, Princeton, NJ.

Manufacturer: Novo Nordisk A/S Bagsvaerd, Denmark.

REASON Defective container; delivery system may dispense less than the expected amount of insulin

VOLUME OF PRODUCT IN COMMERCE 83,789 units.

DISTRIBUTION Nationwide and Puerto Rico.

PRODUCT SYNTEST H.S. (Half Strength Tablets), (Esterified estrogens 0.625mg and Methyltestosterone 1.25mg), 100 Tablet bottles, Rx only.

CODE Lot S02D02, expiration date 3/2004

RECALLING FIRM/MANUFACTURER Syntho Pharmaceuticals, Inc., Farmingdale, NY

REASON Mislabeling; package insert incorrectly indicates dosage strength of Syntest D.S. as 2.5mg of Esterified Estrogens and 5mg Methyltestosterone rather than correctly as 1.25mg Esterified Estrogens and 2.5mg Methyltestosterone.

VOLUME OF PRODUCT IN COMMERCE 10,008 bottles (100 tablets per bottle).

DISTRIBUTION KY.

WEEK ENDING DECEMBER 28

PRODUCT a) Children's Tylenol (Acetaminophen) Oral Suspension, 160 mg, 4 Fl oz (120mL) bottles, Bubblegum Flavor,
b) Children's Tylenol (Acetaminophen) Oral Suspension, 160mg, 4 Fl oz (120mL), Grape Flavor.
CODE a) Lot #EFM041 exp 7/04; b) Lot #EFM040 exp 7/04.
RECALLING FIRM/MANUFACTURER McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, PA

REASON Defective container; product packaged with incorrect dosing cups marked with metric measurements rather than with U.S. standard measurements
VOLUME OF PRODUCT IN COMMERCE 116172 bottles.
DISTRIBUTION Nationwide.