NOVEMBER 2004

WEEK ENDING NOVEMBER 6

PRODUCT ADVAIR DISKUS® Inhalation Powder, (fluticasone propionate/salmeterol inhalation powder), 100/50mcg, one Diskus Inhalation Device containing 1 Foil Strip of 60 blisters, For Oral Inhalation Only, Rx only, NDC 0173-0695-00. 
CODE Lot Numbers: 4ZP2067, 4ZP2104, 4ZP2201, 4ZP2216, 4ZP2217, 4ZP2229, 4ZP2377, 4ZP2474, 4ZP2475, 4ZP2619, 4ZP2759, 4ZP2807, 4ZP2913, 4ZP2901, 4ZP3041, 4ZP3042, 4ZP3139, 4ZP3244, 4ZP3272, 4ZP3373, 4ZP3444, 4ZP3504, 4ZP3550, 4ZP3631, 4ZP3659, Expiration dates: Ranging between May 2005 and July 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 409,382 units.
DISTRIBUTION Nationwide.

Actra-RX "Dietary Supplements" Promoted For Sexual Enhancement Contains Undeclared Prescription Drug Ingredient

Consumers were warned not to purchase or to consume Actra-Rx or Yilishen, two products promoted and offered for sale on Web sites as "dietary supplements" for treating erectile dysfunction and enhancing sexual performance for men. These products in fact contain an active prescription drug ingredient. 

A research letter published in the Journal of the American Medical Association described the results of a chemical analysis of Actra-Rx, finding that each capsule analyzed contained prescription-strength quantities of sildenafil. Sildenafil is the active drug ingredient in Viagra, a Pfizer prescription drug product approved in the United States for the treatment of erectile dysfunction. FDA conducted its own tests of Actra-Rx and found that the product contained prescription-strength sildenafil.

An interaction between sildenafil and certain prescription drugs containing nitrates (such as nitroglycerin) or nitrates found in illicit substances (such as amyl nitrate) may cause a significant lowering of blood pressure to an unsafe level. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Because erectile dysfunction can be a common problem in individuals with these conditions, these consumers may take Actra-Rx or Yilishen and risk experiencing serious adverse effects. Anyone experiencing erectile dysfunction should seek guidance from their health care provider before purchasing a product to treat that condition.

Consumers who have taken Actra-Rx or Yilishen should stop taking it and consult with their health care providers regarding erectile dysfunction treatment. Consumers who are seeking treatment for erectile dysfunction should not take Actra-Rx or Yilishen as either can be dangerous to their health and even life-threatening.

WEEK ENDING NOVEMBER 13

PRODUCT Isosorbide Mononitrate, 30 mg. Extended release tablets, Rx only, 100 count bottles. NDC 59930-1502-1. 
CODE Lot 43480001; exp 08/2007.
RECALLING FIRM/MANUFACTURER Schwarz Pharma Manufacturing, Seymour, IN.
REASON Mislabeling: The label does not declare the presence of the following inactive ingredients: hydrogenated castor oil, lactose monohydrate, microcrystalline cellulose and talc.
VOLUME OF PRODUCT IN COMMERCE 39,322 bottles.
DISTRIBUTION Nationwide.

PRODUCT
a) TIAZAC Capsules (diltiazem hydrochloride), 180mg, Extended Release, USP, 30 and 90 count bottles, Rx only.
b) TIAZAC Capsules (diltiazem hydrochloride) 300mg, Extended Release, USP, 30 and 90 count bottles, Rx only. 
CODE
a) 30 count bottles are identified with the following Lot Numbers: 040178A, 040178B, 036401B & 035980A, Expiration Date: FEB 28 07. 90 count bottles: 040178C, 036401A, 036401D & 039580B, Expiration Date: FEB 28 07;
b) 30 count bottles are identified with the following Lot Numbers: 036457, 035057A, & 040072A, Expiration Date: MAR 31 07. 90 count bottles: 035057B, 035976, 040072C & 040072B, Expiration Date: MAR 31 07.
RECALLING FIRM/MANUFACTURER Amerisource Health Services, Corp, Columbus, OH.
REASON Dissolution failure (by manufacturer).
VOLUME OF PRODUCT IN COMMERCE 13,320 bottles x 90 and/or 30 count repacked bottles.
DISTRIBUTION Nationwide.

PRODUCT A+D Original Ointment (Lanolin, 15.5% and Petrolatum, 53.4%), 4 oz tubes and 1 lb. jars. 
CODE Lot Number/NDC Number/ No Expiration Date: 4CL035, 11523-0096-2; 4G01A2, 11523-0096-3; 4G02A2, 11523-0096-3.
RECALLING FIRM/MANUFACTURER Schering Plough Corp., Kenilworth, NJ.
REASON Mislabeling: The Spanish text on the labeling incorrectly states 7 "horas" (hours) instead of 7 "dias" (days).
VOLUME OF PRODUCT IN COMMERCE 14,160 tubes and jars.
DISTRIBUTION Nationwide.

Kingsway Trading Recalls EXPELLIN EXTRACT and CARDIO FLEX Dietary Herbal Supplements Because of Possible Health Risk

Kingsway Trading Inc. of Brooklyn, NY, is recalling the dietary herbal supplements DOUBLE DEERS FORMULA brand EXPELLIN EXTRACT (CONCENTRATED) and CARDIOFLEX as they contain Aristolochic Acid, and present a serious health risk to consumers. Aristolochic Acid is a potent carcinogen and nephrotoxin found in certain plants and botanicals. Products that contain Aristolochic Acid have been associated with several occurrences of kidney failure. The use of Aristolochic Acid containing products has been linked to increased risk of kidney cancer in people who have consumed it.

DOUBLE DEERS FORMULA brandEXPELLIN EXTRACT (CONCENTRATED) and CARDIOFLEX were imported from China, and distributed nationwide to retail stores and acupuncture clinics from May 2000 to the present. DOUBLE DEERS FORMULA brandEXPELLIN EXTRACT (CONCENTRATED) pills are packed in amber plastic bottles with safety caps and packaged into green cardboard boxes with black lettering on the white panel & red line. CARDIOFLEX pills are packed in white plastic bottles with safety caps and packaged into white cardboard boxes with black lettering and pink & blue colored stripes. The plastic bottles are labeled similarly to the outer boxes. All lots are covered in this recall action.

Consumers who have purchased these products should immediately discontinue their use and return them to the place of purchase for a full refund.

Consumers with questions may contact the company at (718) 366-2300.

WEEK ENDING NOVEMBER 20

PRODUCT Ciprofloxacin Ophthalmic Solution USP 0.3%, Each ml contains 3.5mg ciprofloxacin hydrochloride equivalent to ciprofloxacin
base 3 mg, 10 mL plastic dropper bottles, Sterile, Rx only, For Topical Opthalmic Use Only, NDC 24208-444-10.
CODE Lot numbers: 775221, 775222, 775231, 775232, 765661, 785181, 785182, 785791, 785792, 805591 and 805602.
RECALLING FIRM/MANUFACTURER Bausch & Lomb, Inc., Tampa, FL.
REASON Presence of Particulate Matter (stability).
VOLUME OF PRODUCT IN COMMERCE 142,459 bottles.
DISTRIBUTION Nationwide.

PRODUCT Amnesteem (Isotretinoin), 40 mg capsules, packaged in 3 x 10 count blister packs within cardboard display box, Rx only, NDC 62794-614-93. 
CODE Lot # RP044731P, Exp Nov 2004.
RECALLING FIRM/MANUFACTURER Bertek Pharm, Greenboro, NC.
REASON Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE 19,280 boxes.
DISTRIBUTION Nationwide.

PRODUCT
a) Lotrimin AF Antifungal (Clotrimazole cream 1%), 12 gram tubes. 
b) Lotrimin AF Antifungal Jock Itch, (Clotrimazole cream 1%), 12g tubes. 
c) Clotrimazole Cream, USP, 1%, 15g and 30g tubes, Rx only.
CODE
a) Lot Number 2-KPE-402, NDC Number 11523-0963-7, Expiration Date: 02-05;
b) Lot Number 2-KPE-102, NDC Number 11523-1125-1, Expiration Date: 03-05;
c) Lot Number 2-KPE-203, NDC Number 59930-1570-1, Expiration Date: 01-05; Lot Number 2-KPE-401, NDC Number 59930-1570-2,
Expiration Date: 01-05.
RECALLING FIRM/MANUFACTURER Schering Plough Corp., Kenilworth, NJ.
REASON Impurities/Degradation Products.
VOLUME OF PRODUCT IN COMMERCE 463,356 tubes.
DISTRIBUTION Nationwide.

WEEK ENDING NOVEMBER 27

PRODUCT Xopenex (levalbuterol HC1) Inhalation Solution Concentrate, 1.25 mg/0.5 mL, 30 Sterile Unit Dose Vials, Dilution required, For Oral Inhalation Only, Rx only, NDC 63402-515-30. 
CODE Lot numbers: S4F162, S4F163, S4F164, S4F165, S4F166, S4G005, S4G006, S4G007, and S4G008.
RECALLING FIRM/MANUFACTURER Sepracor, Inc., Marlborough, MA.
REASON Good Manufacturing Practice (GMP) deviation (process validation).
VOLUME OF PRODUCT IN COMMERCE 669,000 vials.
DISTRIBUTION Nationwide and PR.

PRODUCT Premarin (conjugated estrogens tablets USP), 0.625 mg, 1,000 tablet bottles, Rx. NDC 0046-0867-91. 
CODE A48207, Exp. 9/05.
RECALLING FIRM/MANUFACTURER Richmond Division of Wyeth Pharmaceuticals, Richmond, VA.
REASON Dissolution failures (stability).
VOLUME OF PRODUCT IN COMMERCE 15,230 bottles.
DISTRIBUTION AR, VA and TN.