SEPTEMBER 2004
WEEK ENDING SEPTEMBER 4
PRODUCT
DMS brand Lidocaine, USP, BP, & Ph. Eur; Acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl),
net wt. 25.00 K.G. .
CODE
Lot LA-03E18-C.
RECALLING FIRM/MANUFACTURER
DSM Pharma Chemicals South Haven Inc., South Haven, MI.
REASON
Presence of foreign particles: Failed USP chloride limit test.
VOLUME OF PRODUCT IN COMMERCE
75 kg..
DISTRIBUTION
MI and Japan.
PRODUCT
Lantus Injection, (insulin glargine (rDNA origin), 100 units/mL (U-100), packaged
in 10-ml vials, Rx only, For Subcutaneous Injection Only.
CODE
40D024, 40D025, and 40D027, Exp. dates for all lots is 02/06.
RECALLING FIRM/MANUFACTURER
Aventis Pharmaceuticals, Inc., Kansas City, MO.
REASON
Lack of sterility assurance (media fill failure).
VOLUME OF PRODUCT IN COMMERCE
347,206 vials.
DISTRIBUTION Nationwide
PRODUCT
Embrex 600, Prenatal vitamin plus chewable calcium tablets, Rx only, NDC 62022-026-01.
CODE
Lot Number/Expiration Date: T-2258 (August 2004),
T-2293 (September 2004), T-2397 (February 2004),
T-2442 (March, 2005).
RECALLING FIRM/MANUFACTURER
Andrx Pharmaceuticals, Inc., Davie, FL.
REASON
Labeling. There is no warning for Phenylketonurics, and no list of inactive
ingredients; the chewable Calcium tablets contain aspartame. Labeling declares
600 mg of Calcium carbonate; product contains 600 mg of calcium as calcium carbonate.
Labeling declares thiamine mononitrate; product contains thiamine hydrochloride.
Labeling declares zinc sulfate but product contains zinc oxide.
VOLUME OF PRODUCT IN COMMERCE
90,475 boxes of 91 sets of two tablets, for a total of 16,466,450 tablets.
DISTRIBUTION
Nationwide.
PRODUCT
Premarin Tablets (conjugated estrogens tablets, USP) 1.25 mg. 100 tablet bottles,
Rx only.
CODE
Lot #034964, Exp. Date: MAY 31, 05
RECALLING FIRM
Recalling Firm: Amerisource Health Services Corp., Columbus, OH
Manufacturer: Ayerst Laboratories Inc, A Wyeth-Ayerst Co, Philadelphia,
PA.
REASON
Dissolution Failure by manufacturer (Wyeth).
VOLUME OF PRODUCT IN COMMERCE
19,997 x 100 tablet bottles.
DISTRIBUTION
Nationwide and Canada.
PRODUCT
Premarin Tablets (conjugated estrogens tablets, USP), 100 tablet bottles, Rx
only.
CODE
Lot Numbers: A49547A, A49547B & A49547C/Expiration Date: 05/05.
RECALLING FIRM
Cardinal Health, Zanesville, OH.
REASON
Dissolution Failure by manufacturer (Wyeth).
VOLUME OF PRODUCT IN COMMERCE
16,081 x 100 tablet bottles.
DISTRIBUTION
Nationwide.
PRODUCT
Concentrated Potassium Chloride Injection, USP, (2 mEq K+/mL) Super-vial, 500mL,
NDC 0254-1940-10. .
CODE
Batch J4D037.
RECALLING FIRM/MANUFACTURER
B. Braun Medical, Inc., Irvine, CA.
REASON
Presence of particulate matter.
VOLUME OF PRODUCT IN COMMERCE
360 (30 cases).
DISTRIBUTION
Nationwide.
PRODUCT
Promotional Antibacterial Soap labeled as "Diovan (valsartan tablets),
40mg, 80mg, 160mg, 320mg", 8 fl. Oz. (235mL) bottles, Compliments of
Novartis.
CODE
N/A
RECALLING FIRM/MANUFACTURER
Novartis Pharmaceuticals Corp., East Hanover, NJ.
REASON
Misbranded.
VOLUME OF PRODUCT IN COMMERCE
100,000 bottles.
DISTRIBUTION
Nationwide.
PRODUCT
Cenestin (synthetic conjugated estrogens, A) Tablets, 0.625 mg., Rx only, 1000
count bottles, NDC 51285-442-05.
CODE
Lot #98387, Expiration Date: JUNE, 2005.
RECALLING FIRM/MANUFACTURER
Barr Pharmaceuticals, Inc., Cincinnati, OH.
REASON
Stability Failure: 36 month stability failure due to excessive moisture.
VOLUME OF PRODUCT IN COMMERCE
861 bottles.
DISTRIBUTION
Nationwide.
PRODUCT Clinimix/Clinimix E Nutrient Profile Guide, Lit #800516; the laminated pocket
guide is applicable to Clinimix E sulfite-free amino acid with electrolytes
in dextrose with calcium injections in 2L vertical peel seal, Rx only.
CODE
Literature #800516.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Round Lake, IL.
REASON
Mislabeling: The Pocket Guide for the Clinimix/Clinimi E parenteral nutritionals
has incorrect dosing/formulation for multiple two-liter size product codes.
VOLUME OF PRODUCT IN COMMERCE
1,189 guides.
DISTRIBUTION
Nationwide, Puerto Rico, and Canada.
PRODUCT
a) Zovia 1/50E-28 Tablets (Ethynodiol Diacetate and Ethinyl Estradiol, USP), 1.0 mg/0.050 mg, Each pink tablet (21)
contains ethynodiol diacetate 1mg and ethinyl estradiol
50 mcg, Each white tablet (7) contains inert
ingredients, 6 tablet dispensers, 28 tablets each, Rx
only, NDC 52544-384-28.
b) Zovia 1/35E-28 (Ethynodiol Diacetate and Ethinyl Estradiol, USP) 1.0 mg/0.035 mg, Each light pink tablet
(21) contains ethynodiol diacetate 1mg and ethinyl estradiol 35 mcg, Each white tablet (7) contains inert
ingredients, 3 tablet dispensers, 28 tablets each, Rx
only, NDC 52544-383-31.
CODE
a) Lot Numbers / Exp Dates 38401B03 - 9/30/2004, 38401D03 -
11/30/2004, 38402D03 - 11/30/2004, 38402J03 - 2/28/2005,
38401R03 -5/30/2005;
b) Lot Numbers with 8/31/2004 exp dates: 38305A03 Lot
Numbers with 10/31/2004 exp dates: 38307C03, 38308C03,
38309C03, 38310C3, 38301D03, 38302D03, 38303D03, 38317D09 ,38318D03, 38319D03 Lot Numbers with 11/30/2004
exp date: 38304D03, 38305D03, 38306D03, 38307D03,
38308D03, 38309D03, 38310D03, 38311D03, 38312D03, 38313D03, 38314D03, 38315D03, 38316D03, 38301E03,
38302E03, 38303E03, 38304E03 Lot Numbers with 12/31/2004
exp dates: 38301G03, 38302G03, 38303G03, 38305G03,
38309G03, 38310G03, 38311G03, Lot Numbers with 4/30/2005
exp dates: 38301M03, 38302M03, 38303M03, 38304M03, Lot
Numbers with 5/31/2005 exp dates: 38306M03, 38307M03,
38301R03 Lot Numbers with 6/30/2005 exp date: 38304R03,
38305R03, 38306R03, 38301X03, 38302X03, 38303X03,
38304X03, 38305X03 Lot Numbers with 8/31/2005 exp dates:
38302A04, 38303A04.
RECALLING FIRM/MANUFACTURER
Watson Laboratories, Inc., Corona, CA.
REASON
There is potential for film/foil separation in the blister packaging of the
product.
VOLUME OF PRODUCT IN COMMERCE
566,951 cartons.
DISTRIBUTION
Nationwide.
PRODUCT
Niaspan Tablets (niacin extended release tablets), 1000 mg, 100 count bottles,
Rx only, NDC 60598-003-01.
CODE
Lot #0208000003, Exp. 03/05.
RECALLING FIRM/MANUFACTURER
KOS Pharmaceuticals, Inc., Miami Lakes, FL.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
4,152 bottles.
DISTRIBUTION
Nationwide.
PRODUCT
Premarin (Conjugated Estrogens Tablets USP), 1.25mg, 100 tablets, Rx only, NDC
# 00046-0866-81.
CODE
Lot 08586, Exp. 05/05 and Lot 09727, Exp. 05/05.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rx PAK, Memphis, TN.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
88,022 bottles of 100.
DISTRIBUTION
Nationwide.
WEEK ENDING SEPTEMBER 11
PRODUCT
a) 5% Benzoyl Peroxide Gel packaged in 1-oz. tubes, 12 per
case, OTC, under the following private labels: Schnucks; 2) Harris Teeter; and 3)
Finast.
b) Invisible Acne Cream (Benzoyl Peroxide 10%), 1-oz.
tubes, 12 per case, OTC, under the following private
labels: 1) Western Family Maximum Strength Invisible Acne Cream; 2) Meijer Invisible Acne Cream Maximum
Strength, 3) Stop & Shop Maximum Strength Invisible
Acne Cream; 4) Best Yet Absolute Elements Maximum Strength Invisible Acne Cream; 5) Premier Value Maximum
Strength Invisible Acne Cream; 6) Finast Maximum
Strength Invisible Acne Cream; 7) Personal Expressions Vanishing Acne Cream; 8) HyVee Maximum Strength
Invisible Acne Cream.
CODE
a) Lot #3J21D and 3L18D;
b) Lot #3J16B, Exp. Oct 2005; 3J16C, Exp. Oct 2005; 3J16D,
Exp. Oct 2005; 3K18B, Exp. Nov 2005; 4A22B, Exp. Jan
2006; 4A22C, Exp. Jan 2006; 4A28A, Exp. Jan 2006; 4B12B,
Exp. Feb 2006; 4B25C, Exp. Feb 2006; 4C03C, Exp. Mar
2006; 4D03A, Exp. Apr 2006; and 4D07A, Exp. Apr 2006.
RECALLING FIRM/MANUFACTURER Quailis, Inc., Des Moines, IA.
REASON
Bacterial contamination.
VOLUME OF PRODUCT IN COMMERCE
48,588 tubes.
DISTRIBUTION
Nationwide.
PRODUCT
Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) 0.45 mg/1.5
mg tablets, Rx only, 1 EZ-DIAL Dispenser of 28 tablets, NDC #0046-0937-09.
CODE
A46796, Exp. March 2005.
RECALLING FIRM/MANUFACTURER
Richmond Division of Wyeth, Richmond, VA.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
24,871 units.
DISTRIBUTION
Nationwide.
WEEK ENDING SEPTEMBER 18
PRODUCT
Zyprexa Tablets, (Olanzapine), 20 mg, 60 count bottles, Orally Disintegrating
Tablets, Rx only, Eli Lilly & Company, Indianapolis, IN 46285, NDC 0002-4420-60.
CODE
Lot 7AA79A, exp Mar 1, 2005 Lot 7EF34A, exp Aug 1, 2005.
RECALLING FIRM/DISTRIBUTOR
Top Rx, Bartlett, TN.
REASON
Adulterated; presence of foreign tablets from sources other than the manufacturer.
VOLUME OF PRODUCT IN COMMERCE
9 bottles.
DISTRIBUTION
Nationwide.
PRODUCT
Non Drowsy Vicks Formula 44 Cough Relief, 4 fl oz.(118mL).
CODE
4010SG2 Exp. DE/05.
RECALLING FIRM/MANUFACTURER
Procter & Gamble Manufacturing Co, Greensboro, NC.
REASON
Shelf cartons labeled as Vicks Formula 44 Cough Relief may contain bottles of
Vicks Formula 44, Multi-Symptom Relief.
VOLUME OF PRODUCT IN COMMERCE
33 cases with 24 bottles per case.
DISTRIBUTION
Nationwide.
PRODUCT
fougeraÆ TipTapToe (Tolnaftate Solution USP, 1%), NET 10.8 mL, CONTAINS: 72
Liquid Filled Swabs --- Athlete's Foot Solution in a unique delivery system
--- with swab+plusÆ technology LIQUID FILLED COTTON SWABS, OTC, E. FOUGERA &
CO., a division of Altana Inc., MELVILLE, NY 11747, NDC 0168-0009-72.
CODE
Lot M447, EXP. 7/05.
RECALLING FIRM/MANUFACTURER
Altana Inc. Melville, NY.
REASON Subpotent: Potential for tolnaftate solution to migrate into the swab tip during
storage thereby producing inconsistent assay results.
VOLUME OF PRODUCT IN COMMERCE
13, 207 packages.
DISTRIBUTION
Nationwide.
PRODUCT
Natural Creations Spur Relief, for external use only.
CODE Z30428 and Z28324.
RECALLING FIRM/MANUFACTURER
Apotheca Naturale, Inc., Woodbine, IA.
REASON
Unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE
260/2-fl. Oz. bottles.
DISTRIBUTION
IA.