NOVEMBER 2002

WEEK ENDING NOVEMBER 2

PRODUCT Fluocinonide Cream USP, 0.05%, Rx only, 15g (0.53oz), 30g (1.1oz), and 60g (2.2oz) tubes.
CODE Lot#: L106046, L106047, L106048, L108101, L108102, L108103, L110094, L110095, L110096, L202079.
RECALLING FIRM/MANUFACTURER Alpharma Uspd, Inc., Lincolnton, NC.
REASON Product exceeded specification for degradant level (18 month stability).
VOLUME OF PRODUCT IN COMMERCE 63852 units, various sizes.
DISTRIBUTION Nationwide.

PRODUCT Select Brand®, Night-Time Adult Cold Medicine, Original Flavor, 6 FL. OZ. (177 mL), clear plastic triangular bottle

CODE 051L1C, Exp 12/04.
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals, Inc., Huntsville, AL.
REASON Subpotent for one active ingredient-pseudoephedrine hydrochloride-by manufacturer (6 month stability).
VOLUME OF PRODUCT IN COMMERCE 35,963 bottles.
DISTRIBUTION AK.

WEEK ENDING NOVEMBER 9

PRODUCT Plasdone K-29/32 (Povidone, USP/Ph.Eur. K-30), 110 lb drums

CODE Lot 0500035188 and 0500035268.

RECALLING FIRM/MANUFACTURER Recalling Firm: International Specialty Products, Wayne, NJ

Manufacturer: ISP Technologies, Texas City, TX.

REASON Product contains metal particles

VOLUME OF PRODUCT IN COMMERCE Lot 05000035188: 24,200 lbs; Lot 05000035268, 13,310 lbs.

DISTRIBUTION OH, DE, IL,

MI, PA, VA, NY, ME and Internationally.

WEEK ENDING NOVEMBER 16

PRODUCT
Liqui-Char (activated charcoal, USP), in an Aqueous Base, 15 grams, 2.5 fl. oz. unit dose bottles
Liqui-Char (activated charcoal, USP), in an Aqueous Base, 25 grams, 4 fl. oz unit dose tubes and bottles
Liqui-Char (activated charcoal, USP), in an Aqueous Base, 30 grams, 4 fl. oz. unit dose bottles
Liqui-Char (activated charcoal, USP) in an Aqueous Base, 50 grams, 8 fl. oz. unit dose tubes and bottles
Liqui-Char (activated charcoal) in a Sorbitol Base, 25 grams, 4 fl. oz. unit dose tubes and bottles
Liqui-Char (activated charcoal, USP) in a Sorbitol Base, 50 grams, 8 fl. oz. unit dose tube
Liqui-Char Oral Suspension (activated charcoal) 50 grams, 240 ml unit dose tube
CODE Liqui-Char in an Aqueous Base, 15gm, 2.5 ounce bottles: J09503 (09/02), K03514 (03/03);
Liqui-Char in an Aqueous Base, 25gm, 4 ounce tubes: K08506 (08/02), K12501 (12/02), M10501 (10/03), N02505 (02/04);
Liqui-Char in an Aqueous Base, 25gm, 4 ounce bottles: J11504 (11/02), K01510 (01/03), K01511 (01/03), K03501 (03/03), K03502 (03/03), K03503 (03/03), K5510 (05/03), K05511 (05/03), M01508 (01/04), M06501 (06/04);
Liqui-Char in an Aqueous Base, 30gm, 4 ounce bottles: J08505 (08/02), M01510 (01/04);
Liqui-Char in an Aqueous Base, 50gm, 8 ounce tubes: K12502 (12/02), M04501 (04/03), M11509 (11/03), M11511 (11/03);
Liqui-Char in an Aqueous Base, 50gm, 8 ounce tubes code:8001E-6: K09501 (09/02), K09502 (09/02). This product is manufactured for Oxford Pharmaceuticals, Masters House 5 Sandridge Close, Harrow, England, HA11XD;
Liqui-Char in an Aqueous Base, 50gm, 8 ounce bottles (NDC52604-8001-08): K01506 (01/03), K01509 (01/03), K02513 (02/03), K03519 (03/03), K03520 (03/03), K03521 (03/03), K03522 (03/03), K05512 (05/03), K05515 (05/03), K06501 (06/03), K06503 (06/03);
Liqui-Char in a Sorbitol base, 25gm/27gm (sorbitol), 4 ounce tubes: K11502 (11/02), K12503 (12/02), M01509 (01/03), M06503 (06/03), M06507 (06/03), M10502 (10/03), M11502 (11/03), N03503 (03/04);
Liqui-Char in a Sorbitol base, 50gm/54gm (sorbitol), 8 ounce bottles: K08502 (08/02), K09503 (09/02), K09504 (09/02), K09505 (09/02), K10503 (10/02), K11508 (11/02), M02501 (09/03), M04502 (04/03), M07502 (07/03), M11504 (11/03), M12501 (12/03) M12503 (12/03), M12504 (12/03).
RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals, Inc., Bristol, TN.
Manufacturer: Jones Pharma, Inc., St. Louis, MO.
REASON Stability; lack of assurance product potency will be maintained through labeled expiration date.
VOLUME OF PRODUCT IN COMMERCE 28,014 units.
DISTRIBUTION Nationwide, England and Canada.

PRODUCT Paradise Gold SUNSCREEN BROAD SPECTRUM PROTECTANT (Octinoxate, Octisalate, Oxybenzone, Avobenzone), SPF 15, 8 FL OZ (237 mL), Exclusively at Walgreens, Deerfield, IL.

CODE 2096B.
RECALLING FIRM/MANUFACTURER Recalling Firm: Tanning Research Laboratories, Inc., Ormond Beach, FL.
Manufacturer: Tanning Research Laboratories, Ormond Beach, FL.
REASON Mislabeling; back label on bottle incorrectly declared as SPF 30 rather than the correct SPF 15.
VOLUME OF PRODUCT IN COMMERCE 5400.
DISTRIBUTION IL, WI, FL, TX, CA, PA, AZ and IN.

PRODUCT Member's Mark ACETAMINOPHEN Caplets, 500 mg, Non Aspirin, Extra Strength, 500 caplets per bottle.

CODE Lot #'s 1CB0498, 1CB1311 and 1HA1970.
RECALLING FIRM/MANUFACTURER Recalling Firm: Leiner Health Products, Carson, CA.
Manufacturer: Leiner Health Products, Fort Mill, SC.
REASON Misbranding; product contains undeclared cherry flavoring.
VOLUME OF PRODUCT IN COMMERCE 14,570,437 caplets.
DISTRIBUTION AR, OH, MD, GA, NH, NC, FL, PA, CA, IL and TX.

PRODUCT Intralipid 20% I.V. Fat Emulsion, For Intravenous Use, (Soybean Oil 20.0g, Phospholipids 1.2g, Glycerin, USP 2.25g) 500 mL bottles, Rx only.
CODE NR66160, NR66161, NR66162, NR66163, NR66164, NR66166, NR66169, NR66170, NR66171.
RECALLING FIRM/MANUFACTURER Fresenius Kabi Clayton L.P., Clayton, NC.
REASON Mislabeling: bottles incorrectly labeled as Intralipid 30% rather than correctly as Intralipid 20%.
VOLUME OF PRODUCT IN COMMERCE 30,115 units.
DISTRIBUTION IL.

NATIONWIDE ALERT ON INJECTABLE DRUGS PREPARED BY URGENT CARE PHARMACY

The Food and Drug Administration (FDA) is announcing a nationwide alert concerning all injectable drugs prepared by Urgent Care Pharmacy of Spartanburg, South Carolina, based on the lack of assurance that their products are sterile. Non-sterility of injectable products can represent a serious hazard to health that could lead to life-threatening injuries and death. FDA inspection of Urgent Care's facility revealed the firm failed to have adequate controls to ensure necessary sterility, including the absence of appropriate testing for potency and sterility prior to distribution.

On September 16, 2002, Urgent Care recalled all lots of its injectable methylprednisolone acetate based on reports of four patients who developed a rare fungal (wangiella) meningitis (a life threatening infection of the lining of the brain and spinal cord) after use of their product. These patients were treated at three different North Carolina hospitals/clinics. Spinal fluid from all of these patients tested positive for a fungus consistent with that found in the Urgent Care product analyzed by both the FDA and Centers for Disease Control and Prevention (CDC). One patient later died despite antifungal therapy.

Urgent Care has refused to voluntarily recall any other injectable products they prepared and refused to provide FDA with a complete list of products they distributed. FDA is working to identify the recipients of these products so that the agency can directly alert them to the serious risks involved. FDA is continuing to work with the Centers for Disease Control, along with officials from both North Carolina and South Carolina, and will take whatever additional action is needed. In the meantime, the South Carolina Board of Pharmacy has issued a Cease and Desist order to halt further sale of products from Urgent Care.

At the present time, based on limited information, FDA is aware that Urgent Care has distributed the following injectable drugs to physicians, hospitals, clinics and consumers in Connecticut, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Mississippi, New Hampshire, North Carolina, South Carolina and Virginia:

Baclofen
Betamethasone
Bimix 30:1 (Phentolamine mesylate/papaverine)
Clonidine
Estradiol
Hydromorphone HCl
Fentanyl
Methylprednisolone acetate
Morphine Sulfate/Bupivacaine
Papaverine HCl
Super Trimix (Papaverine HCl/phentolamine mesylate/prostaglandin)
Testosterone cypionate
Testosterone/Estradiol

Urgent Care injectables are labeled as:

URGENT CARE PHARMACY 2500 WINCHESTER PLACE , STE. 106, SPARTANBURG, SC 29301 800-692-8982.

Consumers, physicians, and health care workers are urged to examine their drug supplies for any Urgent Care injectable products and immediately discontinue their use. Users should also notify FDA of any complaints or problems associated with these products. These reports may be made to MedWatch, the FDA’s voluntary reporting program, by phone at 1-800-FDA-1088 or on line at http://www.fda.gov/medwatch/how.htm

WEEK ENDING NOVEMBER 23

PRODUCT PRO-RED Syrup Antitussive, Nasal Decongestant, Antihistamine, Alcohol Free, (Hydrocodone bitartrate 2mg, Phenylephrine hydrochloride 5mg, Pyrilamine maleate 8.33mg) 4 FL.OZ. (118 mL) and 16 FL.OZ. (473 mL) bottles, Rx Only.
CODE Lot# 01092 Exp 06/2004.
RECALLING FIRM/MANUFACTURER Great Southern Laboratories, Houston, TX

REASON Yeast contamination (saccromyces cervisiae) causing bottles to swell
VOLUME OF PRODUCT IN COMMERCE 3913 (16 oz bottles) and 315 (4 oz bottles).
DISTRIBUTION MO, IA, and IL.

PRODUCT 1) Cefuroxime for Injection, USP, 1.5g, Novaplus brand, Infusion Bottle, For Intravenous Use, Rx only.
2 A) Cefuroxime for Injection USP, 7.5g, Novaplus brand, Pharmacy Bulk Package, For Intravenous Use, Not For Direct Infusion, Rx only;
2 B) Cefuroxime for Injection USP, 7.5g, AmeriNet Choice brand, Pharmacy Bulk Package, For Intravenous Use, Not For Direct Infusion, Rx only.
3) Kefurox (Cefuroxime for Injection USP), 7.5g, Lilly brand, Pharmacy Bulk Package, For Intravenous Use, Not For Direct Infusion, Rx only.
CODE Lot No. (Exp. date)
Cefuroxime for Injection, USP, 1.5g W8740Y3(1-Jan-03)

Cefuroxime for Injection USP, 7.5g F3530Y2 (1-Mar-03), Z4420Y1 (1-Apr-03), Z4460Y1 (1-Apr-03), Z4460Y6 (1-Apr-03), F0290Y2 (1-Jan-03), F3530Y1 (1-Mar-03), Z4430Y5 (1-May-03).

Kefurox (Cefuroxime for Injection USP), 7.5g F0290Y3 (1-Jan-03), F3530Y3 (1-Mar-03), Z4420Y2 (1-Apr-03).
RECALLING FIRM/MANUFACTURER Recalling Firm: Eli Lilly and Co., Indianapolis, IN.
Manufacturer: Eli Lilly Italia, S.P.A., Sesto Fiorentino, Italy.
REASON Discoloration: product exceeded specification for color level (18 month stability).
VOLUME OF PRODUCT IN COMMERCE 25,500 units.
DISTRIBUTION Nationwide.

PRODUCT Premarin Tablets (conjugated estrogens tablets, USP) 1.25 mg, 100, 1000 and 5000 count bottles, Rx, only.
CODE 100s: Lot 9981205, Exp. 3/02
1000s: Lot 9981348, Exp. 3/03
5000s: Lot 9981207, Exp. 3/03.
RECALLING FIRM/MANUFACTURER Recalling Firm: Wyeth Pharmaceuticals, Richmond, VA.
Manufacturer: Ayerst Laboratories, Inc., Rouses Point, NY.
REASON Failure to meet dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE 100s: 1,487 btls; 1000s: 1,514 btls; 5000s: 1,800 btls.
DISTRIBUTION Nationwide.

PRODUCT Pyrethrin Lice Treatment (Piperonyl Butoxide 4% and Pyrethrum Extract (equivalent to 0.33% Pyrethrins), Kinray Preferred Plus brand, A Creme Rinse Application, 2 fl. oz. (59 mL) bottles, single and twin packs.
CODE 2F15A, exp. June 2004 (single unit)
2G02A, exp. July 2004 (twin pack)
2G25D, exp. July 2004 (twin pack).
RECALLING FIRM/MANUFACTURER Qualis, Inc., Des Moines, IA.
REASON Mislabeling; one active ingredient is incorrectly declared on the bottle label as Permethrin rather than correctly as Pyrethrin.
VOLUME OF PRODUCT IN COMMERCE 504 single units and 384 twin packs; 118 single packs and 245 twin packages have been quarantined at the own-label distributor awaiting return to Qualis.
DISTRIBUTION NY.

WEEK ENDING NOVEMBER 30

PRODUCT Robinul Forte Tablets (glycopyrrolate tablets USP) 2mg, physician sample cartons of 8 tablets (2 cards @4 tablets per card), Rx only.
CODE Lot Number H020572.
RECALLING FIRM/MANUFACTURER Recalling Firm: First Horizon Pharmaceutical Corp., Alpharetta, GA.
Manufacturer: Mikart, Inc., Pharmaceutical Manufacturers, Atlanta, GA.
REASON Product contains glass particles.
VOLUME OF PRODUCT IN COMMERCE 386 cartons (8 tablets each/2 blister cards of 4 tablets per card).
DISTRIBUTION Nationwide.

PRODUCT Etodolac Extended-Release Tablets, 500 mg, 100 count bottles, Rx only.
CODE Lot number 502044 exp. 2/04.
RECALLING FIRM/MANUFACTURER Recalling Firm: Teva Pharmaceuticals USA Inc., North Wales, PA.
Manufacturer: Teva Pharmaceuticals USA Inc., Jerusalem, Israel.
REASON Tablet mixup; a bottle labeled to contain Etodolac Extended-Release tablets was found to contain both Etodolac Extended-Release tablets and one tablet of Tramadol HCl 50 mg
VOLUME OF PRODUCT IN COMMERCE 4084 bottles.
DISTRIBUTION Nationwide.

PRODUCT a) R-Tanna S Pediatric Suspension (Chlorpheniramine Tannate 4.5mg and Phenylephrine tannate 5 mg) 4 fl oz (118mL) bottles, Rx only; b) CP-Tannic Suspension (Chlorpheniramine tannate 4.5mg and Phenylephrine tannate 75mg) 4fl oz (118mL) and 16fl oz (473mL) bottles, Rx only.
CODE a) Lot# GB024; b) Lot# GA984, GA986, GB005, GB033 and GB036.
RECALLING FIRM/MANUFACTURER Recalling Firm: Kiel Laboratories, Inc., Gainesville, GA.
REASON SUBPOTENT; R-Tanna S Pediatric Suspension for phenylephrine tannate (3 month stability); CP-Tannic Suspension for chlorpheniramine tannate ( 1 month stability).
VOLUME OF PRODUCT IN COMMERCE a) 5463 bottles; b) 12817 bottles.
DISTRIBUTION OH and MS.

PRODUCT Rhinocort Nasal Inhaler (budesonide) 7 g, 200 Metered Doses, For Nasal Inhalation with Rhinocort Adaptor Only, Rx only.

CODE Lot Number: CH300; Exp. Date: February 28,2003.
RECALLING FIRM/MANUFACTURER Recalling Firm: Astra Zeneca, Wilmington, DE.
Manufacturer: 3m Health Care, Ltd,. Leicestershire, England.
REASON Defective container; inhaler may not consistently deliver acceptable spray after the initial spray

VOLUME OF PRODUCT IN COMMERCE 90,540 units.
DISTRIBUTION Nationwide.