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SafetyAlerts
March 26, 2003

L. Perrigo Has Recalled Children's Pain Reliever

(SafetyAlerts) - The Food and Drug Administration (FDA) has released the following information.


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; Recall # D-164-3.
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. Recall # D-165-3.
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.
Recall # D-166-3.

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, by letters on January 28, 2003. Firm initiated recall is ongoing.

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.

 

 
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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.