PRODUCT Rapid Clear Eye Wash, in 16-fluid ounce bottles, Rx for flushing or irrigating the eye.
CODE Item #90329, Lot #1006 EXP 01/02.
MANUFACTURER H.L. Burton Company, Inc., Buzzards Bay, Massachusetts.
DISTRIBUTION Illinois.
QUANTITY 206 bottles were distributed.
REASON Misbranding - Product contains undeclared preservative-chlorhexidine gluconate.

PRODUCT Oxygen, USP, compressed, in E and D cylinders.
CODE Lot Numbers: 102999A and 100899B.
MANUFACTURER Family Healthcare Supply, Inc., Sarasota, Florida.
DISTRIBUTION Florida.
QUANTITY 4 tanks.
REASON Good manufacturing deviations - Including but not limited to purity and strength testing.

PRODUCT Cafergot(r) Suppositories (ergotamine tartrate USP .2mg/caffeine USP 100 mg), Rx indicated as therapy to abort or prevent vascular headache
CODE Lot #130B9188 EXP 4/01.
MANUFACTURER Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
DISTRIBUTION Nationwide.
QUANTITY 4,942 cartons (12 blister packs per carton) were distributed; firm estimated that 5% or less remained on market at time of recall initiation.
REASON Subpotency - Ergotamine at 6-month stability testing.

PRODUCT Calcium Gluconate Injection, USP, 10%, in 50-mL single dose and in 200-mL pharmacy bulk packages, under the following labels: Fujisawa - NDC #0469-0311-50 and 0469-0311-63; APP - NDC #63323-311-63.
CODE Lot Numbers: 180156, 180180, 180232, 180274, 180170, 180265, 180458, 180538, 180657, 190441, 190629, 190736, 190836.
MANUFACTURER American Pharmaceutical Partners, Inc., Melrose Park, Illinois.
DISTRIBUTION Nationwide, Uruguay, Hong Kong, Israel, Singapore.
QUANTITY 106,875 50-mL vials and 77,000 200-mL vials were distributed; firm estimated that 25% of the product remained on market at time of recall initiation.
REASON Particulate matter in some vials.

PRODUCT Diltiazem Hydrochloride Tablets, USP, in 60 mg bottles of 100 and 500, Rx indicated for the management of chronic stable angina and angina due to coronary artery spasm.
CODE Lot #662F01 EXP 5/00.
MANUFACTURER Copley Pharmaceutical, Inc., Canton, Massachusetts.
DISTRIBUTION Nationwide.
QUANTITY 2,576 100-tablet bottles and 903 500-tablet bottles were distributed.
REASON Dissolution failure (stability).

WEEK ENDING APRIL 14

PRODUCT Nasacort(r) AQ, Nasal Spray (Triamcinolone acetonide-16.5 grams), 120 metered acutations, Rx for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 6 years of age and older.
CODE Lot #MN3270 EXP 12/00.
MANUFACTURER Rhone Poulenc Rorer, Puerto Rico, Inc., Manati, Puerto Rico.
RECALLED BY Aventis (formerly Rhone Poulenc Rorer), Collegeville, Pennsylvania
DISTRIBUTION Nationwide and Thailand.
QUANTITY 45,900 units were distributed; firm estimates none remains on the market.
REASON Super-potency (stability).

PRODUCT Isoxsuprine HCL Tablets, 10 mg and 20 mg, USP, in 100 and 1,000 tablet bottles, Rx indicated for the relief of symptoms associated with cerebral vascular insufficiency. under the following labels:
Eon: NDC 0185-0530-01 (10 mg, bottles of 100s)
NDC 0185-0530-10 (10 mg, bottles of 1000s)
NDC 0185-0531-01 (20 mg, bottles of 100s)
NDC 0185-0531-10 (20 mg, bottles of 1000s)
Major: NDC 0904-0635-60 (10 mg, bottles of 100s)
NDC 0904-0636-60 (20 mg, tablets of 100s)
NDC 0904-0636-80 (20 mg, bottles of 1000s).
CODE All lots within expiration date.
MANUFACTURER Eon Labs Manufacturing, Inc., Laurelton, New York.
DISTRIBUTION Nationwide.
QUANTITY 10 mg bottles of 100s, Eon Label: 42,009 units Major Label: 3,180 units
10 mg bottles of 1000s, Eon Label: 901 units Major Label: 0 units
20 mg bottles of 100s, Eon Label: 27,911 units Major Label: 1,707 units
20 mg bottles of 1000s, Eon Label: 6,291 units Major Label: 2,169 units.
REASON Dissolution failure (42 month stability).

PRODUCT CIS-Sulfur Colloid(tm) Kit (Technetium Tc 99m Sulfur Colloid Injection), used in adults and
children as an agent for imaging areas of functioning reticuloendothelial cells in the liver, spleen and bone marrow.
CODE Lot No. EXP
6363A 12/31/99
6364 1/31/00
6365A 1/31/00
6366A 2/29/00
6367A 1/31/00
6368 2/29/00
6369 2/29/00
6370A 3/31/00
6371 4/30/00
6372 4/30/00
6373B 4/30/00
6374B 6/30/00
6375B 9/30/00
6376 10/31/00
6377B 12/31/00.
MANUFACTURER CIS-US, Inc., Bedford, Massachusetts.
DISTRIBUTION Nationwide, New Zealand, Panama, Puerto Rico, Guam.
QUANTITY 11,548 kits.
REASON Misbranding - Solution B vial has reversed the strength (mg/ml) of the two ingredients on its immediate vial label.

PRODUCT CombiPatch(tm) Transdermal System, (estradiol-0.62 mg/norethindrone acetate-2.7mg), Rx used by women with an intact uterus for treatment of moderate to severe vasomotor symptoms associated with menopause; treatment of vulvar and vaginal atrophy; and treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.
CODE Lot Numbers: 8F0308E1C1 EXP 4/00 and 9D2703E1C1 EXP 2/01.
MANUFACTURER Noven Pharmaceuticals, Inc., Miami, Florida.
RECALLED BY Aventis (formerly Rhone Poulenc Rorer), Collegeville, Pennsylvania
DISTRIBUTION Nationwide, Bermuda, Puerto Rico.
QUANTITY 41,810 boxes of lot 8F0308E1 and 23,350 boxes of lot 9D2703E1C1 were distributed.
REASON Dissolution and appearance specification failure (excess crystals).