MARCH 2003
WEEK ENDING MARCH 1
PRODUCT Gonal-F (follitropin alfa for injection) 1200 IU
Multi-dose vial for injection copackaged with one pre-filled syringe containing
2 mL Bacteriostatic Water for Injection, USP, Rx Only, For subcutaneous use,
NDC 44087-1200-1.
CODE Gonal F lot numbers:
BK006A, BK007A, BK008B, BK009A, BK010B, BK012A, BK013A
(Prefilled Syringe Diluent Lot Numbers: 1-BEX-701, 1-BEX-702, and 2-BEX-701).
RECALLING FIRM/MANUFACTURER Serono Laboratories, Inc, Rockland, MA,
REASON
Lack of
assurance of sterility for the copackaged pre-filled diluent
syringes(manufactured by Schering Plough Corporation) copackaged with Gonal-F.
VOLUME OF PRODUCT IN COMMERCE 92,653 units.
DISTRIBUTION Nationwide.
PRODUCT Codimal DM Syrup, For Cough/Colds,(Dextromethorphan hydrobromide
10 mg, Phenylephrine hydrochloride 5 mg, and Pyrilamine maleate 8.33 mg) 118mL
(4 Fl oz) and 473mL (1 Pint) bottles
CODE
a) Lot 1125601 NDC#0131-5131-70 - 473mL (1 Pint) bottles,
b) Lot 1125602 NDC#0131-5131-64 - 118mL (4 Fl oz) bottles.
RECALLING FIRM/MANUFACTURER Schwarz Pharma Manufacturing, Seymour, IN,
REASON
Cross
contamination-product contains traces of iron from another oral iron product.
VOLUME OF PRODUCT IN COMMERCE a) 706 bottles; b) 23,683 bottles.
DISTRIBUTION Nationwide and Guyana, Jamaica, Peru, Dominican Republic,
Chile, and Uraguay.
PRODUCT Hydrocodone Bitartrate and Acetaminophen Tablets, USP,
5mg/500mg, 100 count bottle, Rx only.
CODE Lot # 062121C.
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte,
NC,
REASON
Mislabeled;
label incorrectly printed with Scheduled Drug Classification as CIV instead of
correctly as CIII.
VOLUME OF PRODUCT IN COMMERCE 1079 bottles (100 tablets per bottle).
DISTRIBUTION Nationwide.
PRODUCT a) Aerozoin,Skin Conditioner For Tape & Cast Dressings, (Tinture of Benzoin, USP 40%),
Net
Wt. 3.5 oz., spray can.
b)
KENZOIN, Skin Conditioner For Tape & Cast Dressings, (Tinture of Benzoin, USP 40%), Net Wt. 4 oz.
(113 Grams).
CODE
a) Aerozoin Lots: 1082902 Exp. 8/05; 1083002 Exp. 8/05;
1090302 Exp. 9/05; 2137 Exp. 7/05; 2137-2 Exp.7/05; 2137-3 Exp 7/05; 2137-4 Exp
7/05; 2137-5 Exp 7/05; 2137-6 Exp 7/05; 2137-7 Exp 7/05;
b) Kenzoin Lot: 2036 Exp. 2/05.
RECALLING FIRM/MANUFACTURER Pel Associates, Inc, North Branch, NJ,
REASON
Failure to
comply with Good Manufacturing Practice Regulations including performance of
finished product assays & manufacturing validation.
VOLUME OF PRODUCT IN COMMERCE 102,864 cans (Aerozoin and Kenzoin).
DISTRIBUTION Nationwide.
PRODUCT Humalog Pen (insulin lispro injection, rDNA origin), U-100, 3 mL, 100
units per mL, disposable insulin delivery system. Rx only, NDC 0002-8725-01
(HP-8725).
CODE Lot FF2S19C, exp. August 1,
2004.
RECALLING FIRM/MANUFACTURER Eli Lilly and Company, Indianapolis, IN.,
REASON Drug cartridges may be cracked or broken.
VOLUME OF PRODUCT IN COMMERCE 12,825.
DISTRIBUTION Nationwide.
PRODUCT
a)
Natural Nasal Decongestant with Echinacea & Valerian, Children's Nightime Cold
Formula, Tom's of Maine,
(Pseudoephedrine HCl) 15mg/teaspoon, Net 4
Fl oz bottles (112 mL), Cherry flavor,
No Alcohol.
b)
Natural Nasal Decongestant with Echinacea, Children's Daytime Cold Formula,
Tom's of Maine, (Pseudoephedrine
HCl), 15mg/teaspoon, Net 4 Fl oz bottles,
Cherry Flavor, No Alcohol.
CODE All lots.
RECALLING FIRM/MANUFACTURER Tom's Of Maine, Inc., Kennebunk, ME,
REASON Misbranded; dosing instructions for children ages 2 to 6 will provide
excessive amounts of active ingredient.
VOLUME OF PRODUCT IN COMMERCE a) 10,188;
b) 6,788.
DISTRIBUTION Nationwide.
PRODUCT Toprol-XL (Metoprolol Succinate) Tablets, 100 mg., 90 tablet
bottles, each extended release tablet
contains 95 mg metoprolol succinate
equivalent to 100 mg metoprolol tartrate, USP; NDC #0339-5783-11.
CODE LN066233, expires 12/19/03.
RECALLING FIRM/MANUFACTURER Caremark Pharmaceutical Services, Vernon
Hills, IL,
REASON Mislabeling; bottles labeled as containing 100 mg tablets actually
contain Toprol XL, 50 mg. Tablets.
VOLUME OF PRODUCT IN COMMERCE 418 bottles.
DISTRIBUTION Nationwide.
PRODUCT
a)
Fluoracaine, Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution USP, Sterile, Rx Only, Active :
Fluorescein Sodium 0.25%, Proparacaine
Hydrochloride 0.5% ; 5 mL glass screw cap vial with black propylene cap and sterile
dropper.
b)
Fluress, Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP; Sterile , Active:
Fluorescein
Sodium 0.25%, Benoxinate Hydrochloride
0.4%, 5 mL glass screw cap vial with
black propylene cap and sterile dropper.
CODE
a) Lot numbers 31061, exp.
3/03; 51121, exp. 5/03; 81051, exp. 8/03; 11302, exp. 1/04; 51222, exp. 5/04,
NDC # 17478-311-10;
b)
Lot numbers 81211, exp. 2/03; 91181, exp. 3/03; 121271, exp. 6/03; 11392, exp.
7/03; 21042, exp. 8/03; 21052,
exp. 8/03; 41422, exp. 10/03; 51062, exp.
11/03.
RECALLING FIRM/MANUFACTURER Akorn, Inc., Decatur, IL, by letter dated
January 14, 2003
REASON Container/closure integrity problems; leaking containers.
VOLUME OF PRODUCT IN COMMERCE a) 129,594 bottles; b) 222,400 bottles.
DISTRIBUTION Nationwide, Bahamas, Israel, the Phillipines, Canada and Australia.
PRODUCT GEMZAR for Injection, (Gemcitabine HCl), 200 mg, For I.V. use only, 10
mL Sterile Single Use Vial, Lilly, Rx Only, Vial No. 7501.
CODE Lot 6MH15.
RECALLING FIRM/MANUFACTURER Eli Lilly & Company, Indianapolis, IN
REASON Container Defect: glass in vials.
VOLUME OF PRODUCT IN COMMERCE 31,200 vials.
DISTRIBUTION Agentina, Brazil, Columbia, Mexico, Taiwan and Venezuela.
PRODUCT ONXOL injection (paclitaxel), 300 mg/50 mL (6mg/mL), 50 mL Multi Dose
Vial, Rx only.
CODE M026861 Exp Date 02/04.
RECALLING FIRM/MANUFACTURER IVAX Pharmaceuticals, Miami, FL,
REASON Lack of assurance of sterility: Environment in Class 100 Filling room
exceeded the non-viable particulate limit specification.
VOLUME OF PRODUCT IN COMMERCE 1,039 vials.
DISTRIBUTION Nationwide.
PRODUCT Levothyroxine Sodium, USP, Tablets, 100 mcg (0.1mg), Rx only, 100
and 1000 count bottles, Also sold under
the Qualitest and URL brand labels.
CODE Lot numbers: 0170120B (Vintage), 100 count bottle NDC# 0254-3914-28;
070120D (Vintage), 1000 count bottle NDC# 0254-3914-38; .070120A (URL), 100
count bottle NDC# 0677-0078-01; and 070120C (Qualitest) 100 count bottle NDC#
0603-4195-21.
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, NC,
REASON Stability; product may not maintain potency through the labeled
expiration date.
VOLUME OF PRODUCT IN COMMERCE 1800 bottles, 070120A; 3600 bottles, 070120B;
6000 bottles, 070120C and
1768
bottles, 070120D.
DISTRIBUTION Nationwide.
PRODUCT Feen-A-Mint Tablets, Laxative, (Bisacodyl ) 5mg, 10 tablet carton.
CODE 1-EGN-4, EXP 1/3.
RECALLING FIRM/MANUFACTURER Schering-Plough HealthCare Products/DBA Bain
deSoleil Co., Cleveland, TN,
REASON Disintegration: failure due to tablet softening.
VOLUME OF PRODUCT IN COMMERCE 109,728 packages.
DISTRIBUTION Nationwide.
PRODUCT Hydrocodone Bitartrate and Acetaminophen Tablets USP, (10/ 500
mg), Qualitest, Rx only, 1000 Tablet
bottles, NDC 0603-3888-32.
CODE Lot # 142081A.
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, NC,
REASON Tablet hardness failure.
VOLUME OF PRODUCT IN COMMERCE 1459 bottles (1000 tablets per bottle).
DISTRIBUTION Nationwide.
PRODUCT
a) Natural Nasal
Decongestant with Echinacea & Valerian,
Adult Nightime Cold Formula, Tom's of Maine, (Pseudoephedrine HCl)
30mg/teaspoon, Liquid, Net 4 Fl oz (112ml) bottles, No Alcohol, Tom's of Maine,
PO Box Kennebunk, ME.
b)
Natural Nasal Decongestant with Echinacea, Adult Daytime Cold Formula, (Pseudoephedrine HCl)
30mg/teaspoon,
Tom's
of Maine, Liquid, Net 4 Fl oz (112ml) bottles, No Alcohol, Tom's of Maine, PO Box Kennebunk, ME 04043.
CODE All lots.
RECALLING FIRM/MANUFACTURER Tom's of Maine, Inc
REASONMisbranded; dosing instructions for adults/children 12 yrs & older
will only provide half of the required amount of active ingredient.
VOLUME OF PRODUCT IN COMMERCE
a)
8,072;
b)
19,738.
DISTRIBUTION Nationwide.
PRODUCT Diltia XT, Extended Release Capsules,(Diltiazem HCl Extended Release
Capsules, USP), 120 mg, 100 and 1000 capsule bottles, Rx only. NDC
62037-548-01(100's) and NDC 62037-548-10 (1000's).
CODE 548B002A, 548B002B, 548B003A ,548B003B, 548B004, 548B005A , 548B005B,
548B006 thru 548B010, 548C001,548C002A ,548C002B, 548C003, 548C004A and
548C004B,548C005 through 548C011A, 548C012C,548C012D, 548C013B and 548C014A.
RECALLING FIRM/MANUFACTURER Andrx Pharmaceuticals, Inc., Fort Lauderdale,
FL,
REASON Dissolution Failure: four hour time point (12 month stability station).
VOLUME OF PRODUCT IN COMMERCE 132,181 100's and 6,080 1000's.
DISTRIBUTION Nationwide.
PRODUCT Micardis Tablets, (telmisartan) 20 mg, 28 tablets, 4 blister cards of 7
tablets each, Rx only, NDC #00597-0039-28.
CODE Lot #106909A, Exp 11/2003; and Lot #205752A, Exp 08/2004.
RECALLING FIRM/MANUFACTURER Recalling Firm: Boehringer Ingelheim Roxane
Laboratories, Columbus, OH,
Manufactured: Boehringer Ingelheim Pharma KG, Ingelheim Germany
REASON Container defect: loss of integrity of the air tight seal on the blister cards.
VOLUME OF PRODUCT IN COMMERCE 264 boxes (73 - lot 106909A;
and 191- lot 205752A).
DISTRIBUTION Nationwide.
PRODUCT
a)
Motrin IB (Ibuprofen tablets USP), 200mg, Coated Caplets, 2 count single dose
packets, McNeil-PPC, Inc., Fort
Washington,
PA. NDC 50580-110-52. .
b)
DayQuil LiquiCaps (Acetaminophen 250mg, Dextromethorphan HBr 10mg and Pseudoephedrine HCl 30mg) 2
count unit dose packages, Handy
Solutions, A Trademark of Navajo Mfg.,
Co., Inc., Denver, CO. Manufactured
by: Procter &
Gamble,
Cincinnati, OH.
CODE a) and b) Lot No. FCC035, Exp. 03/05.
RECALLING FIRM/MANUFACTURER Navajo Manufacturing Company, Inc., Denver,
CO
REASON Mispackaged by Recaller; packets of Motrin IB were incorrectly
repackaged in hanging card packages labeled to contain DayQuil LiquiCaps.
VOLUME OF PRODUCT IN COMMERCE Approx. 1470 units.
DISTRIBUTION Nationwide.
PRODUCT Ketoprofen, U.S.P., bulk pharmaceutical powder, CAS 22071-15-4, 5 g, 25
g, 100 g and 1Kg containers, Rx only.
CODE Lots QK1162, QW0807.
RECALLING FIRM/MANUFACTURER Spectrum Laboratory Products Inc., Gardena,
CA,
REASON Superpotency Clindamycin phosphate..
VOLUME OF PRODUCT IN COMMERCE 7,734 - 1 oz. bottles and 6,315 - 2 oz.
Bottles.
DISTRIBUTION Nationwide.
CODE Lot number
24667, Expiration date 04/04; packaged as the following sub- lots 1 oz. bottles
- sublot 24667A 2 oz. bottles - sublots 24667C and 24667E.
RECALLING FIRM/MANUFACTURER Morton Grove Pharmaceuticals,
Inc., Morton Grove, IL
REASON Superpotency Clindamycin phosphate.
VOLUME OF PRODUCT IN COMMERCE 7,734 - 1 oz. Bottles and
6,315 - 2 oz. Bottles.
DISTRIBUTION PA, NY, MO, FL, OH, CA and Puerto Rico.
PRODUCT: Rhinaris, Lubricating Nasal
Mist, non-medicated, Mixture of polyethylene glycol 15%, and propylene glycol
5% in a solution containing 0.02% benzalkonium chloride as a preservative. 33
FL. OZ. (10 mL) and 1 FL. OZ. (30 mL) bottles. NDC 51817-071-01(.33 fl oz), NDC
51817-071-02 (1 fl oz).
CODE: 209281, Exp. MA 07 (MA = May)-----.33 fl oz.
bottles; 209280, Exp. MA 07 (MA=May)-------1 fl. oz bottles.
RECALLING FIRM/MANUFACTURER: Recalling Firm: Pharmascience, Inc.,
Tonawanda, NY,
Manufacturer: Pharmascience¸ Inc., Montreal, Canada
REASON: Microbial Contamination: Pseudomonas fluorescens.
VOLUME OF PRODUCT IN COMMERCE: 10,000 bottles (.33); 1,345 bottles (1
fl. Oz.).
DISTRIBUTION: Nationwide.
PRODUCT: Premarin Tablets (conjugated estrogens tablets, USP) 0.625 mg,
unit dose packages of 100, and bottles of 1,000 count, Rx only. NDC numbers:
0046-0867-95 (bottles of 1000) and 0046-0967-99 (unit dose packages).
CODE: 1,000 tablet bottles: LOT #1A03925, EXP 12/02;100
unit dose tablets: LOT #1A03960, EXP 05/05; LOT #1B00084, EXP 05/05.
RECALLING FIRM/MANUFACTURER: Recalling Firm: Amerisource Health
Services, Corp. Columbus, OH
Manufacturer: Ayerst Laboratories Inc., A Wyeth-Ayerst Company,
Philadelphia, PA.
REASON: Dissolution Failure: by manufacturer.
VOLUME OF PRODUCT IN COMMERCE: 26 packages and 3,870 bottles.
DISTRIBUTION: Nationwide and Puerto Rico.
Tai
Chien Inc. is recalling all 100-tablet bottles of Ancom Anti-Hypertensive
Compound Tablets, an unapproved new drug labeled to contain several
prescription drug ingredients, including reserpine, diazepam, promethiazine,
and hydrochlorothiazide. The sale of a product with this combination of
ingredients poses possible serious health risks including sedation, depression,
and potentially life-threatening abnormalities of the blood. This recall includes all lot codes of the
product remaining on the market.
Ancom
Tablets were sold without prescriptions to consumers at Tai Chien's retail
establishment in New York City. Product was also sold to a distributor in
Puerto Rico.
Ancom
Tablets are labeled for anti-hypertensive use and are packaged in white plastic
bottles of 100 tablets bearing blue and white lettered labeling. Each bottle is
sold in an outer cardboard holding carton. Both the carton and immediate
container label bear the product name as Ancom tablets, Anti-hypertensive
Compound, and display the manufacture's name as Shanghai Pharmaceutical
Industry Corp., Shanghai, China. The labeling also bears Chinese markings,
which appear to be dual declarations. The holding carton is white with a pink
and blue vertical stripe bearing blue and white lettering. The product carton
also includes a pre-printed insert labeled with an ingredient statement and
directions for use.
Consumers who purchased Ancom Anti-Hypertensive
Compound Tablets are urged to immediately discontinue use of the product and
return it to the place of purchase for a full refund. Consumers with questions may contact the company at
1-212-431-5636.
PRODUCT a) Antacid Liquid (Aluminum hydroxide 200mg, Magnesium hydroxide
200mg and Simethicone 20mg) 6 fl oz (177mL),
12 fl oz (355mL) and 24 fl oz (710mL) bottles, Fast- Acting, Antacid/Antigas,
Original Flavor. Also sold under other brands as: Liquid Antacid, Distributed
by: Dolgencorp, Inc., Goodlettsville, TN; Liquid Antacid, Distributed By:
Foodhold U.S.A. Incorporated,
Chantilly, VA; Liquid Antacid, Distributed By: Super G, Inc., Landover, MD;
Antacid plus Simethicone, Distribution By Family Dollar Services, Inc.,
Charlotte, NC; Antacid Liquid with Simethicone, Distributed By Quality Choice,
Novi, MI; Antacid plus Simethicone, Distributed by Fred'sInc., Memphis, TN.
b) Antacid Supreme Liquid (Calcium carbonate 400mg, Magnesium hydroxide 135mg)
12 fl oz (355mL) bottles,Fast Acting, Cherry flavor. Also sold under other brands
as: Antacid Supreme, Cherry flavor, Distributed by Ingles, Asheville, NC;
Antacid Supreme, Cherry
flavor, Distributed by: Food Lion Stores, LLC, Salisbury, NC; Antacid Supreme,
Cherry flavor, Distributed by: Dolgencorp Inc., Goodlettsville, TN.
c) Antacid Liquid, ( Aluminum hydroxide 200mg, Magnesium hydroxide 200mg,
Simethicone 20mg) 6 fl oz (177ml) and 12 fl oz (355mL) bottles,
Antacid/Anti-Gas, Mint flavor, Also sold under other brands as: Antacid Liquid,
Cooling Mint flavor, Distributed By: Super G, Inc., Landover, MD; Antacid
Liquid, Mint flavor, Distributed By Quality Choice, Novi, MI; Antacid Liquid,
Cooling Mint flavor, Distributed By: Foodhold U.S.A. Incorporated, Chantilly, VA;
Antacid Liquid, Cooling Mint flavor, Distributed By: The Stop & Shop
Supermarket Co., Boston, MA.
d) Antacid II, (Aluminum hydroxide 400mg, Magnesium hydroxide 400mg,
Simethicone 40mg) 12 Fl oz (355mL) bottles, Maximum Strength, Original flavor,
Fast-Acting, Antacid/Antigas, Distributed by Fred''s, Inc., Memphis, TN.
e) Antacid Liquid (Aluminum hydroxide 400mg, Magnesium hydroxide 400mg,
Simethicone 40mg), 5 Fl oz (148mL) bottle, Maximum Strength, Lemon flavor,
Antacid, Anti-Gas.
f)
Antacid Liquid (Aluminum hydroxide 500mg, Magnesium hydroxide 450mg,
Simethicone 40mg) 12 Fl oz (355mL) bottles, Extra Strength, Fast-Acting,
Antacid/Anti Gas, Lemon Creme Flavor, Distributed by Fred's, Inc., Memphis, TX.
g) Antacid Liquid (Aluminum hydroxide 500mg, Magnesium hydroxide 450mg,
Simethicone 40mg) 5 Fl oz (148mL) bottles, Extra Strength, Fast Relief, Antacid
Anti-Gas Plus, Lemon Flavor.
h)
Antacid Liquid (Aluminum hydroxide 225mg and Magnesium hydroxide 200mg) 12 Fl
oz (355mL) bottle, Mint Creme flavor, Distributed By Warehouse Concepts, Inc.,
West Sacramento, CA..
i) Antacid Supreme Liquid (Calcium Carbonate 400mg and Magnesium hydroxide
135mg) 12 Fl oz (355mL) bottle, Fast Acting, Mint Creme flavor, Distributed by
Longs Drugs, Walnut Creek, CA.
j) Antacid Supreme Liquid (Calcium carbonate 400mg and Magnesium hydroxide
135mg) 12 Fl oz (355mL) bottle, Fast Acting, Cherry Creme flavor, Distributed
by Longs Drugs, Walnut Creek, CA.
CODE
a) Lots 11933; 11970; 11971; 11972; 11973; 11998; 12119; 12120; 12183; 12184;
12468; 12469; 12558; 12605; 12606; 12607; 12645; 12646; 12647; 12666; 12700;
12709; 12710; 12817; 12819; 12820; 12833; 12859; 12860; 12863; 12889; 12917.
b) Lots 12041; 12171; 12298; 12339; 12465; 12816; 12821;12890.
c) Lots 11978; 12651; 12652; 12711; 12712; 12885.
d) Lots 12086; 12578.
e) Lot 12115.
f) Lots 12087; 12701; 12702B.
g) Lot 12663; 12664.
h) Lot 11979.
i) Lots 11866; 12662.
j) Lots 11865; 12825.
RECALLING FIRM/MANUFACTURER Aaron Industries, Inc., Lynwood, CA.
REASON Microbial contamination (Enterobacter cloacae, Citrobacter
freundii, Klebsiella terrigena, Flavimonas oryzihabitans and Salmonella
arizonae).
VOLUME OF PRODUCT IN COMMERCE 500,422.
DISTRIBUTION Nationwide.
PRODUCT a) Children's Pain Reliever, (Acetaminophen) 80 mg per 1/2 teaspoon,
4 Fl. oz. bottles, Bubble Gum flavor, Equate brand; Also sold under other
brands as: Brite-Life brand, Distributed By Bergen Brunswig Drug Company, Orange,
CA; Longs brand, Longs Drugs, Walnut Creek, CA; Western Family brand, Western
Family Foods, Inc., Portland, OR; HomeBest brand, Preferred Products, Inc.,
Eden Prairie, MN; Good Neighbor Pharmacy, Bergen Brunswig Drug Company, Orange,
CA; Top Care brand, Topco Assoc, Inc., Skokie, IL; Leader brand, Cardinal
Distribution Dublin, OH; Shaw's brand, Shaw's Supermarkets, Inc., E.
Bridgewater, MA; Kroger brand, The Kroger Co., Cincinnati, OH; Good Sense
brand, Perrigo, Allegan, MI; Food Lion brand, Food Lion, LLC, Salisbury, NC;
Sav-on Osco by Albertson's brand, Albertson's Inc., Boise, ID Children's
Acetaminophen Suspension, Equate brand, Manufactured By Perrigo Company,
Allegan MI, Imported By Shandex Sales Group, LTD, Pickering, Ontario; Brooks
brand, Maxi Drug, Inc., d/b/a Brooks Pharmacy, Warwick, RI; Safeway brand,
Prepared For Canada Safeway Limited, Calgary Alberta, By Perrigo Company,
Allegan, MI, Imported By Shandex Sales Group, LTD, Pickering, Ontario; Life
brand, Manufactured for Shoppers Drug Mart, Pharmaprix, Toronto, by Perrigo
Co., Allegan, MI Imported by Shandex Sales Group, LTD, Pickering, Ontario;
Personnelle brand, Manufactured By; Perrigo Co., Allegan, MI, For Le Groupe
Jean Coutu (PJC) Inc., The Jean Coutu Group, Inc., Longueuil (Quebec), Imported
By: Shandex Sales Group, LTD, Pickering (Ontario) Children's Pain Relief Oral
Suspension, American Fare brand, Made for Kmart Corporation, Troy, MI, CVS
Pharmacy brand, CVS Pharmacy, Inc., Woonsocket, RI; Finast brand, Foodhold USA,
Inc., Chantilly, VA; Giant Eagle brand, Giant Eagle, Inc., Pittsburgh, PA;
H-E-B Pharmacy brand, H-E-B, San Antonio, TX; Hy-Vee brand, Hy-Vee, Inc., West
Des Moines, IA; Stop & Shop brand, The Stop & Shop Supermarket Co.,
Boston, MA; Children's Aspirin Free Suspension Liquid, Meijer brand, Meijer
Distribution, Inc., Grand Rapids, MI; Non-Aspirin Children's Suspension, Eckerd
brand, Eckerd Drug Company, Clearwater, FL; Rite Aid brand, Rite Aid
Corporation, Harrisburg, PA; ShopRite brand, Wakefern, Food Corporation, Elizabeth,
NJ; Walgreens brand, Walgreen Co., Deerfield, IL; ValuRite brand, McKessonHBOC,
San Francisco, CA;
b) Children's Pain Reliever Suspension Liquid, (Acetaminophen) 80 mg per 1/2
teaspoon, 4 Fl. oz and 8 Fl. oz. bottles, Grape flavor, Equate brand.Also sold
under other brands as: Leader brand, Cardinal Distribution, A Division of
Cardinal Health, Inc., Dublin, OH; Best Yet brand, Fleming, Oklahoma, OK Drug Emporium
brand, Packaged by Perrigo Company, Allegan, MI, For Drug Emporium, Inc.,
Powell, OH; Elect Health brand, ShopKo Stores, Inc., Green Bay, WI; Top Care brand,
Topco Associates LLC, Skokie, IL; HomesBest brand, Preferred Products, Inc.,
Eden Prairie, MN; Good Neighbor Pharmacy, Bergen Brunswig Drug Company, Orange,
CA; Brite-Life brand, Bergen Brunswig Drug Company, Orange, CA Western Family
brand, Western family Foods, Inc., Portland, OR; Good Sense brand, Perrigo,
Allegan, MI; Today's Health brand, Warehouse Concepts, Inc., West Sacramento,
CA; Kroger brand, The Kroger, Co.,Cincinnati, OH; Longs brand, Longs Drugs,
Walnut Creek, CA; Hannaford brand, Hannaford Bros., Co., Scarborough, ME;
Family Pharmacy brand, Family Pharmacy, Southeastern, PA; Children's
Acetaminophen Suspension Liquid, Brooks brand, Maxi Drug, Inc., d/b/a Brooks Pharmacy,
Warwick, RI Life brand, manufactured for Shoppers Drug Mart Pharmaprix,
Toronto, by Perrigo Co., Allegan, MI, Imported by Shandex Sales Group, Ltd., Pickering,
Ontario Equate brand, Manufactured By Perrigo Company, Allegan, MI, Imported By
Shandex Sales Group LTD., Pickering, Ontario Safeway brand, Prepared For Canada
Safeway Limited, Calgary, Alberta, By Perrigo Company, Allegan, MI, Imported By
Shandex Sales Group LTD., pickering, Ontario Personnelle brand, Manufactured By:
Perrigo Co., Allegan, MI, For Le Groupe Jean Coutu
(PJC) Inc., The Jean Coutu Group (PJC) Inc., Longueuil (Quebec), Imported By:
Shandex Sales Group, LTD., Pickering (Ontario) Kaiser Permanente brand, Kaiser Foundation
Hospitals, Livermore, CA Target brand, Target Corporation, Minneapolis, MN
Children's Mapap
Suspension Liquid, Major brand, Major Pharmaceuticals, Livonia, MI Children's
Pain Relief Oral Suspension, Wegmans brand, Wegmans Food Markets, Inc.,
Rochester, NY; Finast brand, Foodhold U.S.A., Incorporated, Chantilly, VA;
Stop&Shop brand, The Stop&Shop
Supermarket Company, Boston, MA; Hy-Vee brand, Hy-Vee, Inc., West Des Moines,
IA; Super G brand, Super G, Inc., Landover, MD; Giant Eagle brand, Giant Eagle,
Inc., Pittsburgh, PA Children's Non-Aspirin Oral Suspension, H-E-B brand,
H-E-B, San Antonio, TX; Best Choice brand, Valu Merchandisers, Co., Kansas
City, MO; CVS Pharmacy brand, CVS Pharmacy, Inc., Woonsocket, RI; Walgreens brand,
Walgreens Co., Deerfield, IL; Rite Aid brand, Rite Aid Corporation, Harrisburg,
PA; Eckerd brand, Eckerd Drug Company, Clearwater, FL; ValuRite brand, McKessonHBOC,
San Francisco, CA; ShopRite brand, Wakefern Food Corporation, Elizabeth, NJ;
Kirkland brand, Manufactured by: Perrigo Co., Allegan, MI; Children's Aspirin
Free Suspension Liquid, Meijer Distribution, Inc., Grand Rapids, MI Medi-Tabs
Oral Suspension, The Medicine Shoppe brand, Medicine Shoppe International,
Inc., St. Louis, MO.
c) Children's Pain Reliever Suspension Liquid, (Acetaminophen) 80 mg per 1/2
teaspoon, 4 Fl. oz bottles, Cherry flavor, Equate brand. Also sold under other
brands as: Good Sense brand, Perrigo, Allegan, MI; Leader brand, Cardinal
Distribution, A Division of Cardinal Health, Inc., Dublin, OH; Best Yet brand, Fleming,
Oklahoma, OK Drug Emporium brand, Packaged by Perrigo Company, Allegan, MI, For
Drug Emporium, Inc., Powell, OH; HomesBest brand, Preferred Products, Inc., Eden
Prairie, MN; Good Neighbor Pharmacy, Bergen Brunswig Drug Company, Orange, CA;
Brite-Life brand, Bergen Brunswig Drug Company, Orange, CA Western Family brand,
Western Family Foods, Inc., Portland, OR; Kroger brand, The Kroger, Co.,
Cincinnati, OH; Longs brand, Longs Drugs, Walnut Creek, CA; Hannaford brand,
Hannaford Bros., Co., Scarborough, ME; Family Pharmacy brand, Family Pharmacy,
Southeastern, PA; DG brand, Dolgencorp, Inc., Goodlettsville, TN; Shaw's brand,
Shaw's Supermarkets, Inc., E. Bridgewater, MA; Food Lion brand, Food Lion LLC,
Salisbury, NC; CounterAct brand, Melaleuca, Inc., Idaho Falls, ID; Sav-on Osco
by Albertson's brand, Albertson's, Inc., Boise, ID; Children's Acetaminophen
Suspension Liquid, Equate brand, Manufactured By Perrigo Company, Allegan, MI, Imported
By Shandex Sales Group LTD., Pickering, Ontario Safeway brand, Prepared For
Canada Safeway Limited, Calgary, Alberta, By Perrigo Company, Allegan, MI,
Imported By Shandex Sales Group LTD., pickering, Ontario Personnelle brand,
Manufactured By: Perrigo Co., Allegan, MI, For Le Groupe Jean Coutu (PJC) Inc.,
The Jean Coutu Group (PJC) Inc., Longueuil (Quebec), Imported By: Shandex Sales
Group, LTD., Pickering
(Ontario) Life brand, manufactured for Shoppers Drug Mart Pharmaprix, Toronto,
by Perrigo Co., Allegan, MI, Imported by Shandex Sales Group, Ltd., Pickering, Ontario
Brooks brand, Maxi Drug, Inc., d/b/a Brooks Pharmacy, Warwick, RI Kaiser
Permanente brand, Kaiser
Foundation Hospitals, Livermore, CA Target brand, Target Corporation,
Minneapolis, MN Children's Pain Relief Oral
Suspension, Wegmans brand, Wegmans Food Markets, Inc., Rochester, NY ; American
Fare brand, Made for Kmart Corporation, Troy, MI; Hy-Vee brand, Hy-Vee, Inc., West
Des Moines, IA; Super G brand, Super G, Inc., Landover, MD; Giant Eagle brand,
Giant Eagle, Inc.,
Pittsburgh, PA Children's Non-Aspirin Oral Suspension, H-E-B brand, H-E-B, San
Antonio, TX; Best Choice brand, Valu Merchandisers, Co., Kansas City, MO; CVS
Pharmacy brand, CVS Pharmacy, Inc., Woonsocket, RI; Walgreens brand, Walgreens
Co., Deerfield, IL; Rite Aid brand, Rite Aid Corporation, Harrisburg, PA;
Eckerd brand, Eckerd Drug Company, Clearwater, FL; ValuRite brand, McKessonHBOC,
San Francisco, CA; Children's Aspirin Free Suspension Liquid, Meijer
Distribution, Inc., Grand Rapids, MI Medi-Tabs Oral Suspension, The Medicine Shoppe
brand, Medicine Shoppe International, Inc., St. Louis, MO Children's Mapap,
Major brand, Major Pharmaceuticals, Livonia, MI APAP brand Paracetamolum, ZAWIESNIA
DOUSTNA DLA DZIECI, 160 mg/5mL, 120ml, SMAK OWOCOWY, US Pharmacia (this product
label is written in Polish for the intent of distribution in Poland.
CODE a) Lots 1BD0043, 1BD0044,0 1DD0285, 1ED0272, 1FD0069, 1FD0339,
1DD0223, 1DD0037, 1ED0090, 1ED0091, 1ED0092, 1FD0340, 1FD0027, 1FD0293,
1GD0074, 1GD0075, 1GD0077, 1HD0023, 1HD0022, 1HD0065, 1HD0299, 1HD0300,
1HD0301, 1HD0364, 1HD0336, 1HD0346, 1KK0061 and 1JK0029.
b) Lots 1BD0191, 1BD0045, 1BD0302, 1DD0078, 1DD0034, 1DD0079, 1DD0080, 1ED0088,
1ED0023, 1ED0089, 1FD0273, 1FD0272, 1FD0023, 1FD0024, 1HD0365, 1FD0337,
1FD0336, 1FD0335, 1FD0289, 1GV0443, 1FD0290, 1FD0291, 1FD0292, 1GD0305,
1GD0306, 1GD0308, 1GD0309, 1GD0310, 1JK0027, 1HD0366, 1HD0330, 1HD0332 and
1JK0026.
c) Lots 1BV0152, 1CV0205, 1BD0041, 1BD0042, 1BD0193V, 1CK0082, 1BD0196V,
1CD0277, 1CD0276, 1BD0293V, 1CK0083, 1CD0279, 1ED0002, 1ED0003, 1FD0305,
1FD0118, 1GD0316, 1ED0003B, 1FD0118B, 1FD0118R, 1GD0086, 1GD0084, 1FD0086, 1GK0016,
1GD0024, 1GV0508, 1GV0467, 1GD0024R, 1HV0375, 1HV0510, 1GD0025, 1GD0026 1GD0028,
1GD0027, 1HD0066, 1HD0066R, 1JV0338, 1HV0705, 1HV0665, 1HV0619, 1JV0460, 1HV0617,
1HD0067, 1HK0092, 1HD0335, 1JK0038, 1JK0037 and 1HD0067B.
RECALLING FIRM/MANUFACTURER L. Perrigo Co., Allegan, MI.
REASON Super-potency; inadequate validation of manufacturing operation.
VOLUME OF PRODUCT IN COMMERCE
a) 851,581 units;
b) 954,494 units;
c) 930,767 units.
DISTRIBUTION Nationwide, Canada and Poland.
PRODUCT
a) Betaxolol
Ophthalmic Solution USP, 0.5%, 5mL , 10mL and 15mL dropper tip bottles, Rx
only, Sterile Ophthalmic Solution, For Topical Ophthalmic Use Only.
b) Timolol Maleate Ophthalmic Solution USP, 0.5%, 10mL and 15mL dropper tip
bottles, Rx only, Sterile Ophthalmic Solution.
c) Carteolol Hydrochloride Ophthalmic Solution USP, 1%, 5mL, 10mL and 15mL
dropper tip bottles, Rx only, SterileOphthalmic Solution, For Topical
Ophthalmic Use Only.
d) Levobunolol HCl Ophthalmic Solution USP, 0.5%, 5mL, 10mL and 15mL dropper
tip bottles, Rx only, Sterile Ophthalmic Solution, For Topical Eye Use.
e) Timolol Maleate Ophthalmic Solution USP, 0.25%, 10mL and 15mL dropper tip
bottles, Rx only, Sterile Ophthalmic Solution.
f) Cromolyn Sodium Ophthalmic Solution USP, 4%, 10mL dropper tip bottle, Rx
only, Sterile: For topical application in the eye.
g) Tobramycin Ophthalmic Solution USP, 0.3%; 5mL dropper tip bottle, Rx only,
Sterile Ophthalmic Solution, For Topical Ophthalmic Use Only.
CODE
All lots of
all sizes.
RECALLING FIRM/MANUFACTURER Novex Pharma, Richmond Hill, Ontario, Canada
REASON
Defective
container; insufficient tightness of caps resulting in evaporation of water in
solution which may cause product to become super-potent.
VOLUME OF PRODUCT IN COMMERCE
a) 29,319 bottles;
b) 142,560 bottles;
c) 725 bottles;
d) 59,887 bottles;
e) 15,804 bottles;
f) 12,328 bottles;
g) 1,937 bottles.
DISTRIBUTION Nationwide and Puerto Rico.
PRODUCT Estrace Tablets (estradiol tablets, USP), 2 mg, bottles of 100
tablets, Rx only.
CODE Lots: #011137, Exp. APR 16 03; #011780, Exp. JUN 23 03; #011851,
Exp. JUL 06 03; and #012022, Exp. AUG 29 03.
RECALLING FIRM/MANUFACTURER Recalling Firm: AmeriSource Health Services
Corp., Columbus, OH.
Manufacturer: Bristol-Myers Squibb Co., Princeton, NJ.
REASON Dissolution Failure: by manufacturer (Bristol-Myers Squibb).
VOLUME OF PRODUCT IN COMMERCE 5,000 bottles.
DISTRIBUTION Nationwide.
PRODUCT a) Nature's Remedy Tablets, (Cascara sagrada 150mg and Aloe 100mg) Laxative, 15, 30 and 60 count
foil-backed blistercard packages.
b)
Nature's Remedy Tablets (Sennosides, USP 8.6mg) Stimulant Laxative, 15, 30, and
60 count foil-backed blistercard packages.
CODE a) Lot Number/Exp. Date: M0013 exp. 3/03; M0014 exp.3/03; M0015
exp. 4/03; M0016 exp. 4/03; M0017 exp. 4/03; M0018
exp. 4/03; M0019 exp. 4/03; M0020 exp. 4/03; M0021 exp. 4/03; M0023 exp. 4/03;
M0024 exp. 4/03; M0025 exp. 4/03;M0026 exp. 4/03; M0028 exp. 4/03. 0022/TAX015
exp 4/03; 0029/TAZ016 exp. 4/03.
b) Lot No./Exp. Date: M 100133 1/03; M100133A 1/03; M103412 5/03; M103413 6/03;
M103414 6/03; M106408 10/03; M106457 10/03; M106458 10/03; M106531 10/03;
M106532 10/03; M200112 1/04; M200113 1/04; M200114 1/04; M201715 3/04; M201716
3/04; M201717 3/04; M202573 4/04; M202574 4/04; M202575 5/04; M202576 5/04;
M202577 5/04; M202578 5/04; M202579 5/04; M202580 5/04; M202580A 5/04; M202581
6/04; M203643 6/04; M203757 6/04; M203758 6/04; M203759 6/04; M204427 7/04;
M204427A 7/04; M204428 7/04; 140100637/LOT H MA/2003; 140103412/LOT I MA/2003;
140200097/LOT J and LOT M200097 JA/2004; 140202576/LOT K MA/2004.
RECALLING FIRM/MANUFACTURER Glaxo Smith Kline, Parsippany, NJ.
REASON
a) Subpotent; active ingredient (Aloe) (stability 12 month timepoint).
b) Superpotent; active ingredient (stability 12 month timepoint)
VOLUME OF PRODUCT IN COMMERCE 1,289,220 units.
DISTRIBUTION Nationwide and Canada.
PRODUCT Conray 43 (Iothalamate meglumine Injection USP 43%), 202 mg/mL
Organically Bound Iodine, 100mL bottle, Rx only, For Intravascular Use, Sterile
Solution, Mallinckrodt Inc., St Louis, MO. NDC 0019-3183-07.
CODE Lot number B371D.
RECALLING FIRM/MANUFACTURER Tyco Healthcare, Raleigh, NC.
REASON Misbranding; product has no immediate bottle label.
VOLUME OF PRODUCT IN COMMERCE 696 cases (12 units per case).
DISTRIBUTION Nationwide.
PRODUCT AVODART Soft Gelatin Capsules, (dutasteride), 0.5 mg, unit dose
pack, 70 capsules, 10 blistercard package containing 7 capsules each, Rx only.
NDC 0173-0712-01.
CODE
Lot number
RP 44904BB, Exp. Date SEP 30 2006.
RECALLING FIRM/MANUFACTURER SmithKline Beecham, Corp., Zebulon, NC.
REASON Mislabeled; blistercard labeling is incorrectly printed as
"Sample-Not for Sale".
VOLUME OF PRODUCT IN COMMERCE 3,059 units.
DISTRIBUTION Nationwide.
PRODUCT Thyrolar 1/4 (liotrix tablets, USP), (Liothyronine sodium (T3)
3.1mcg and Levothyroxine sodium (T4) 12.5mcg, 100-tablet bottles, Rx only.
CODE
Lot #60135,
Exp. 06/2003.
RECALLING FIRM/MANUFACTURER Forest Pharmaceuticals, Inc., Earth City, MO.
REASON Superpotent; excessive tablet weight specification limits.
VOLUME OF PRODUCT IN COMMERCE 8,235/100-tablet bottles.
DISTRIBUTION Nationwide.
PRODUCT a) PREMARIN Tablets, 0.9 mg (conjugated estrogens tablets, USP),
100 tablet bottles, Rx Only.
b) Premarin tablets, 1.25 mg, (conjugated estrogens tablets, USP), 5,000 count
bottles, Rx Only.
CODE
a) 9981732, Exp. August 2003; 9990073, Exp. August 2003.
b) 9000073, Exp. July 2004; 9010066, Exp. August 2003; 9010248, Exp. August
2003.
RECALLING FIRM/MANUFACTURER Robins, A.H./Division of American Home
Products, Richmond, VA.
REASON Dissolution Failure: 5 hour time point.
VOLUME OF PRODUCT IN COMMERCE a) 74,211 units; b) 1,893 units.
DISTRIBUTION Nationwide.