Natural Organics, Inc. Issues Allergy Alert on Undeclared Casein in Bottles and Sample Packets of "Nature’s Plus Animal Parade Children’s Chewable Calcium, Natural Vanilla Sundae Flavor"

DECEMBER 2004

WEEK ENDING DECEMBER 4

Natural Organics, Inc. Issues Allergy Alert on Undeclared Casein in Bottles and Sample Packets of "Nature’s Plus Animal Parade Children’s Chewable Calcium, Natural Vanilla Sundae Flavor"

Natural Organics Inc. of Melville, NY is recalling certain lots of 90-count bottles of "Nature's Plus Animal Parade Children's Chewable Calcium, Natural Vanilla Sundae Flavor" (Product Nos. 29996, E2999601, E2999602), and 2-count sample packets of "Nature's Plus Animal Parade Children's Chewable Calcium, Natural Vanilla Sundae Flavor" (Product No. 79996), because they may contain trace amounts of undeclared casein, a milk derivative, therefore posing a potential health hazard to individuals with milk allergies or severe sensitivity to milk.

The product was distributed nationwide to retail stores and to the following foreign countries: United Kingdom, Northern Ireland, Republic of Ireland, France, Russia, South Korea, Indonesia, Singapore, Japan, Philippines, Netherlands, Germany, Spain, Italy, Switzerland, Honduras, Trinidad, Jamaica, and United Arab Emirates.

The product is a white chewable tablet in various animal shapes contained in a 90-count amber plastic bottle bearing a lot number printed on the bottom of the bottle, or in sample packets containing 2 chewable tablets. The following bottled lot numbers are affected: 1021176, 1026101, 1027564,1031816, 1034956, 1036178, 1037365, 1040904, 1042758, 1044825, 1047386, 1047393, 1047525, 1048517,1050151, 1050154, 1051997,1053348, 1053973, 1054445, 1057193, 1057397, 1057707, 1060047, 1060499, 1060500,1060806, 1061489, 1061901, 1061981, 1063812, 1064562, 1064940, 1065113, 1066328, 1066447, 1069110, 1070316, 1073315, 1074734, 1075490, 1076653, 1070724, 1077869, 1079306, 1081876, 1082099.

The following sample packet lot numbers are affected: 03703A, 1037089, 14204A, 19703C, 27203A, 32103A, A31902.

Consumers who have purchased the affected 90-count bottles of "Nature's Plus Animal Parade Children's Chewable Calcium, Natural Vanilla Sundae Flavor " and/or have been given the 2-count Sample packets of "Nature's Plus Animal Parade Children's Chewable Calcium, Natural Vanilla Sundae Flavor" are advised to return them to the place of purchase.

Consumers with questions may contact the company at 1-800-645-9500.

Nationwide Recall of American Health & Herbs Ministry Eye Rinse Products

Alternative Health & Herbs Remedies of Albany, OR, announced today that it is conducting a voluntary nationwide recall of all lots of four American Health & Herbs Ministry brand eye rinse products. These include Eye Rinse Concentrate formula 1036 live concentrated herbal tincture, White Willow Bark 3193 live concentrated herbal tincture, Fennel Seed 3126 live concentrated herbal tincture and Elderberry Flower 3247 live concentrated herbal tincture. Products are packaged in 2 oz. and 8 oz. brown glass bottles.

Approximately 300 bottles of these products have been distributed nationwide since November 1, 2002. All lots of these four products are subject to this recall action, irrespective of the lot number and expiration date shown on the bottle.

Consumers who may have any of these products on hand are advised not to use them as eye drops or eye washes. Consumers are asked to return them to Alternative Health & Herbs Remedies, P.O. Box 217, Albany, OR 97321 or discard them and send Alternative Health & Herbs Remedies a purchase receipt for a full refund.

Consumers with questions may call Alternative Health & Herbs Remedies at 1-800-345-4152.

WEEK ENDING DECEMBER 11

PRODUCT

a) Top Care®, Distilled Extract of Witch Hazel, Alcohol 14% by Volume, For Relief of Minor Skin Irritations Due to Insect bites, Minor Cuts and Minor Scrapes, 16 FL OZ (1 PT) 473 mL. The Witch Hazel product is filled in a natural-colored (clear) HDPE bottle.
b) Top Care®, Hydrogen Peroxide Solution usp, First Aid Antiseptic, For Treatment of Minor Cuts and Abrasions, For use as an Antiseptic Gargle or Rinse, 16FL OZ (1 PT) 473 mL. Hydrogen Peroxide is filled in a brown opaque HDPE bottle to protect it from the damaging effects of light.
CODE a) and b) Lot #HB1118F.
RECALLING FIRM/MANUFACTURER Aaron Industries, Inc., Lynwood , CA.
REASON Mislabeling: Witch Hazel product is labeled TopCare® Hydrogen Peroxide, instead of TopCare® Witch Hazel.
VOLUME OF PRODUCT IN COMMERCE 663/16 oz. bottles.
DISTRIBUTION IL.

PRODUCT Estrace (estradiol tablets, USP) 1 mg tablets. 100 trade package.
CODE Lot 4C82237 exp. 3/07.
RECALLING FIRM/MANUFACTURER Warner Chilcott Inc, Rockaway, NJ.
REASON Mislabeling: Outer carton incorrectly states contains 0.5mg estradiol whereas the bottle label correctly states contains 1.0mg estradiol.
VOLUME OF PRODUCT IN COMMERCE 2,368 bottles.
DISTRIBUTION Nationwide.

PRODUCT Bacitracin Ointment USP, (Bacitracin) 500 units, 144 Unit dose packets, NET WT 0.9 grams each, A First Aid Antibiotic, NDC0182-0232-30.
CODE Lot number: AW247.
RECALLING FIRM/MANUFACTURER IVAX Pharmaceuticals, Inc., Miami , FL.
REASON Mispackaging; product carton labeled as Bacitracin Ointment USP actually contains correctly labeled packets of Triple Antibiotic Ointment.
VOLUME OF PRODUCT IN COMMERCE 6,668 cases.
DISTRIBUTION Nationwide.

PRODUCT GoodSense brand Children’s Allergy Relief, (Loratadine) Oral Solution, 5mg/5mL, 4 fl. oz. (120 mL) bottles, Fruit Flavored Syrup, Antihistamine, Non-Drowsy, over-the-counter, Manufactured by Perrigo Company, Allegan, MI ----- Also sold under the following brand names: Kroger brand Children’s Allergy Relief, Distributed by The Kroger Co., Cincinnati, OH NDC 30142-649-26 -- Walgreens brand Children’s Wal-itin Allergy Relief, Dist. by Walgreen Co., Deerfield, IL NDC 0363-0649-26 -- Good Neighbor Pharmacy brand Allergy Relief for Kids, Distributed by AmerisourceBergen, Valley Forge, PA NDC 24385-531-26 -- Longs brand Children''s Loratadine, Dist. by Longs Drug Stores, Walnut Creek, CA NDC 12333-9113-1 -- Brite-Life brand Allergy Relief for Kids, Dist. by AmerisourceBergen, Valley Forge, PA NDC 24385-531-26 -- Topcare brand Allergy Relief, Dist. by Topco Associates LLC, Skokie, IL NDC 36800-649-26 -- CVS Pharmacy brand Children’s Allergy Relief, Dist. by CVS Pharmacy, Inc., Woonsocket, RI -- HyVee brand Allergy Relief, Dist. by Hy-Vee, Inc., West Des Moines, IA -- Equate brand Allergy Relief, Packaged by: Perrigo, Allegan, MI, Dist. by Wal-Mart Stores, Inc., Bentonville, AR NDC 49035-649-26 -- American Fare brand Allergy Relief, Made for Kmart Corporation, Troy, MI NDC 49738-649-26 -- Publix brand Children’s Allergy Relief, Dist. by Publix Super Markets, Inc., Lakeland, FL NDC 56062-649-26 -- Sunmark brand Children’s Allergy Relief, Loratadine Syrup, Dist. by McKesson, San Francisco, CA NDC 49348-636-34 -- FOOD LION brand Allergy Relief for Kids, Distributed by Food Lion LLC, Salisbury, NC NDC 55316-649-26 -- Safeway brand Children’s Allergy Relief, Dist. by Safeway Inc., Pleasanton, CA NDC 21130-649-26 -- Rite Aid brand Children’s Loratadine Syrup, Dist. by Rite Aid Corporation, Harrisburg, PA -- Family Pharmacy brand Allergy Relief for Kids, Distributed by Family Pharmacy, Valley Forge, PA NDC 52735-374-41 -- Major brand Allergy Relief for Kids, Dist. by Major Pharmaceuticals, Livonia, MI NDC 0904-5671-20 -- Equaline brand Children’s Allergy Relief, Dist. by Albertsons Inc., Boise, ID NDC 41163-649-26 -- Berkley & Jensen brand Children’s Loratadine Syrup, Dist. by BJWC, Natick, MA -- Careone brand Allergy Relief, Dist. by American Sales Company, Lancaster, NY -- Eckerd brand Children’s Allergy Relief, Dist. by Eckerd Drug Company, Clearwater, FL NDC 19458-9403-1 -- Western Family brand Children’s Allergy Relief, Dist. by Western Family Foods, Inc., Portland, OR -- Target brand Children’s Allergy Relief, Dist. by Target Corporation, Minneapolis, MN NDC 11673-649-26 -- Today''s Health brand Children’s Allergy Relief, Dist. by Warehouse Concepts, Inc., West Sacramento, CA NDC 38309-649-26 -- The Medicine Shoppe brand Allergy Relief for Kids, Dist. by Medicine Shoppe International, Inc., St. Louis, MO NDC 49614-174-26 -- Leader brand allergy Relief, Dist. by Cardinal Health, Inc., Dublin, OH NDC 37205-378-26 -- Healthy Generations brand Loratadine Syrup, Dist. by Supervalu Inc, Eden Prairie, MN -- Alavert Children’s Allergy Relief, Dist Wyeth Consumer Healthcare, Madison, NJ – Children’s DimetappND, Dist. Wyeth Consumer Healthcare, Madison, NJ -- Sav-on Osco by Albertson’s brand Children’s Allergy Relief, Dist. by Albertson’s Inc., Boise, ID NDC 41163-649-26 -- H.E.B. Pharmacy brand Children’s Allergy Relief, Dist. by H-E-B, San Antonio, TX NDC 37808-649-26 -- Meijer brand Children’s Allergy Relief, Dist. by Meijer Distribution, Inc., Grand Rapids, MI NDC 41250-649-26
CODE All Lots.
RECALLING FIRM/MANUFACTURER Perrigo Company, Allegan , MI.
REASON Impurities; product exceeds impurity specification (6 month stability).
VOLUME OF PRODUCT IN COMMERCE 2,851,097 bottles.
DISTRIBUTION Nationwide.

Bextra Label Updated with Boxed Warning Concerning Severe Skin Reactions and Warning Regarding Cardiovascular Risk

The Food and Drug Administration (FDA) announced today important new information on side effects associated with the use of Bextra, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID) which is indicated for the treatment of osteoarthritis, rheumatoid arthritis and dysmenorrhea (menstrual pain). A "boxed" warning, strengthening previous warnings about the risk of life-threatening skin reactions and a new bolded warning contraindicating the use of Bextra in patients undergoing coronary artery bypass graft (CABG) surgery will be added to the label.

Boxed and bolded warnings provide healthcare professionals and patients with important information on drugs that may be associated with serious side effects in a way that maximizes the drug’s benefits and minimizes its risks.

Serious Skin Reactions

The new boxed warning in the label states that patients taking Bextra have reported serious, potentially fatal skin reactions, including Steven-Johnson Syndrome and toxic epidermal necrolysis. These skin reactions are most likely to occur in the first 2 weeks of treatment, but can occur any time during therapy. In a few cases, these reactions have resulted in death. The labeling advises doctors that Bextra should be discontinued at the first appearance of a skin rash, mucosal lesions (such as sores on the inside of the mouth), or any other sign of allergic reactions. The new boxed warning also states that Bextra contains sulfa, and patients with a history of allergic reactions to sulfa may be at a greater risk of skin reactions.

Cardiovascular Risks

In addition to highlighting serious skin reactions, the strengthened label warnings also highlight new data about cardiovascular risks. A recently-completed study conducted by Pfizer, which included over 1,500 patients treated after CABG, showed an increased cardiovascular risk in patients treated with Bextra compared to placebo. Observed cardiovascular events included thromboembolic events such as myocardial infarction (heart attack), cerebrovascular accident (stroke), deep vein thrombosis (blood clots in the leg), and pulmonary embolism (blood clot in the lung).

Pfizer submitted the final report of the new CABG study to FDA on November 5, 2004. The report confirms the risk of the intravenous form (about 2 percent of patients had such an adverse event) and also shows that oral Bextra is associated with a lower, but some, risk (about 1 percent of patients) immediately following CABG surgery--a very specific medical setting. In the placebo group, about 0.5 percent of patients had an adverse cardiovascular event. Bextra is not approved for use in the treatment of postoperative pain of any type; however, FDA believes that these new findings should be made available to healthcare professionals and patients, and the bolded warning specifically contraindicates Bextra for treatment of pain immediately following CABG.

FDA urges health care providers and patients to report adverse event information to FDA via the MedWatch program by phone (1-800-FDA-1088), by fax (1-800-FDA-0178), or by the Internet http://www.fda.gov/medwatch/index.html . Reports can also be made directly to Pfizer, Inc., Peapack, N.J. at 1-800-323-4204.

WEEK ENDING DECEMBER 25

PRODUCT Twice-a-Day 12 HOUR NASAL SPRAY (oxymetazoline hydrocholoride 0.05%), sold in 1/2 FL. OZ (14.8mL) and 1 FL. OZ. (30mL) bottles, MAJOR brand, Regular, NASAL DECONGESTANT, --- NDC 0904-5217-35 -- Also sold under other name brand as: DU brand Nasal Spray Atomizador, Maximum Strength, Nasal Decongestant Spray.
CODE Lots sold under MAJOR brand: K4496, A4588, L4535, E4410, F4433, H4464, L4529, M4536, A4558 and B459. Lot sold under DU brand: J4492.
RECALLING FIRM/MANUFACTURER Propharma, Inc., Miami, FL.
REASON Microbial Contamination; Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE 416,677
DISTRIBUTION Nationwide and PR.

PRODUCT Noveon CA-1 (calcium polycarbonphil) Bulk Active Pharmaceutical Ingredient, 100 kg fiber board drums.
CODE Lot code No: TD44HD1756, TD44HD1758, TD44HD1759, TD44HD1760, TD44HD1761, TD44HD1762, TD44HD1763, TD44HD1764, TD44HD1765, TD44HD1766, TD45HD1767, TD45HD1768, TD45HD1769, TD45HD1770, TD45HD1771, TD45HD1772, TD45HD1773, TD45HD1774, TD45HD1775, TD45HD1776, TD45HD1777, TD45HD1778, TD45HD1779, TD45HD1780, TD45HD1781, TD46HD1783, TD46HD1784, TD46HD1785, TD46HD1786, TD46HD1787, TD46HD1789, TD46HD1790, TD46HD1791, TD46HD1792, TD46HD1793, TD46HD1797, TD47HD1798, TD47HD1799.
RECALLING FIRM/MANUFACTURER Noveon Inc., Cleveland, OH.
REASON Contamination with small latex glove pieces.
VOLUME OF PRODUCT IN COMMERCE 683/100 kg. Drums.
DISTRIBUTION NJ, CT, and MI.

PRODUCT RU-21 Tablets Dietary Supplement, 20 count blister packages.
CODE Lot numbers: 12/02, 03/03, 10/03, 11/03, 02/04.
RECALLING FIRM/MANUFACTURER Spirit Sciences USA, Inc., Beverly Hills, CA.

REASON Unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE 382,464 blister packages.
DISTRIBUTION Nationwide.

PRODUCT Ipratropium Bromide Inhalation Solution 0.02% (0.5 mg/vial) 60 x 2.5 mL Unit-Dose Vials (12 vials per foil pouch), For Oral Inhalation Only, Rx Only, NDC 0472-0753-60.
CODE Lot A4B031 EXP 02/06.
RECALLING FIRM/MANUFACTURER Alpharma USPD, Baltimore, MD.
REASON Exceeds impurity specification (terephthalic acid).
VOLUME OF PRODUCT IN COMMERCE 176,400 vials.
DISTRIBUTION NY.

PRODUCT ONCASPAR Pegaspargase (PEG-L-asparaginase), 750 I.U. per mL, one 5.0 mL single dose vial, Sterile, for intrasmuscular use only, contains no preservative, Rx only, NDC 57665-002-02.
CODE Lot AB0303, Exp. 2/25/05; Lot AK0332, Exp. 1/7/06.
RECALLING FIRM/MANUFACTURER Enzon Pharmaceuticals, Inc., South Plainfield, NJ.

REASON Superpotent; product exceeds in-vitro enzyme levels (18 month stability).
VOLUME OF PRODUCT IN COMMERCE 4,105 vials.
DISTRIBUTION Nationwide and Internationally.

PRODUCT ADVAIR DISKUS 100/50mcg (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder), 60 Doses per unit, For Oral Inhalation Only, Rx only, NDC 0173-0695-00.
CODE Lot #B133672/Expiration Date: 7/2005.
RECALLING FIRM/MANUFACTURER GlaxoSmithKline, Inc., Zebulon, NC.
REASON Defective container; patients may not receive medication as it is advanced through the Diskus unit.
VOLUME OF PRODUCT IN COMMERCE 19,120 units.
DISTRIBUTION Nationwide.