WEEK ENDING OCTOBER 6

PRODUCT Suprax Tablets, 400 mg, Rx, used to treat bacterial infections
CODE Lot #S078RB EXP 1/31/00.
MANUFACTURER Pharmaceutical Corporation of America, Carmel, Indiana.
DISTRIBUTION Wyoming.
QUANTITY 56 bottles were distributed.
REASON Label mix-up - Product bore a bar code for Cefadroxil.

WEEK ENDING OCTOBER 13

PRODUCT BC(r) brand Headache Powder (650 mg Aspirin, 195 mg Salicylamide, 33.3 Caffeine), packaged in 2's NDC# 1015800908, packaged in 6's NDC# 1015800910, packaged in 24's NDC# 1015800912, packaged in 50's
CODE Lot Numbers: M000580, M000581, M000582, M000583, M000857, M000858, M000859, M000860, M000861, M000862, M000863, M000864, M000865, M000866, M001703, M001704, M001705, M001706, M001707, M001708, M001709, M001710, M001711, M001712, M002205, M002206, M002207, M002208, M002209, M002210, M002211, M002212, M002213, M002214, M002771, M002772, M002773, M002774, M002780, M002903, M002904, M002905, M002906, M002907, M002908, M002909, M002910, M002911, M002912, M003265, M003390, M003391, M003392, M003393, M003394, M003395, M003396, M003397, M003398, M003420, M003428, M003429, M003430, M003431, M003432, M003433, M003434, M003435, M003436, M003437, M004001, M004049, M004050, M004051, M004052, M004053.
MANUFACTURER Block Drug Company, Memphis, Tennessee.
RECALLED BY Block Drug Company, Jersey, City, New Jersey
DISTRIBUTION Nationwide.
QUANTITY
BC Powder 2"s ---316,714/60dz
BC Powder 6's ----180,232/60dz
BC Powder 24's ----1,806/3dz
BC Powder 50's ----18,188/3dz were distributed.
REASON Discoloring of glassine envelopes holding product.

WEEK ENDING OCTOBER 27

PRODUCT Illumine (tm) 30 Minute in-Office Tooth Whitener, 30% Hydrogen Peroxide.
CODE Catalog #614037P (20 pack) and 614037 (10 pack); Lot Numbers: 1229, 1234, 1240, 1241, 1251, 1253, 1254, 1255, 1259, 1259A, 1262, and 1280.
MANUFACTURER Dentsply Preventive Care, York, Pennsylvania.
DISTRIBUTION Nationwide, Mexico, Germany, Argentina, Brazil, Australia, Japan, Hong Kong.
QUANTITY 100,408 syringes (1,210 20-packs and 180 10-packs) were distributed.
REASON Defective coupling valve (stopcock) resulting in the forceful ejection of contents.

PRODUCT Iopamidol-300 (Iopamidol Injection, USP) 61%, 150 mL in a 200 mL vial, Single Dose, Rx for intravascular use for angiography throughout the cardiovascular system and intravenous adult and pediatric contrast enhancement of computed tomographic head and body imaging.
CODE Lot Numbers: 100119 EXP 02/02 and 100393 EXP 05/02.
MANUFACTURER American Pharmaceutical Partners, Inc., Melrose Park, Illinois.
DISTRIBUTION California and Virginia.
QUANTITY 7,800 vials were distributed; firm estimated that 10 percent of product remained on market at time of recall initiation.
REASON Lack of efficacy.