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SafetyAlerts
November 1, 2001

York Pharmaceuticals recalls aspirin tablets under many retail names

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Kansas City, KS  (SafetyAlerts) - The Food and Drug Administration (FDA) said that York Pharmaceuticals, Inc. is recalling  aspirin tablets under many retail names.

This is the first public notice of this Class llI recall issued by the FDA.

REASON:
Dissolution failures (starting at 2 months of stability)

MANUFACTURER/RECALLING FIRM:
York Pharmaceuticals, Inc., Kansas City, KS

RECALLED BY:
York via letter dated 7/11/01.

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide

QUANTITY:
Uncoated Tablet Btls: 100-ct.-640,368; 200 ct.-402,399; 250-ct.-40,104; 500-ct.-15,660; 1,000-ct.-69,060

Coated Tablet Btls: - 100-ct.-324,720; 200-ct.-114,288;
250-ct.-23,904; 300-ct.-85,968; 500-ct.-36,984; 1,000-ct.-2,160;

BULK COATED TABLETS -
4,050,000; and 1/1,994-kg. drum.

RECALL NUMBER, PRODUCT AND CODE:
D-001-2, Aspirin tablets (uncoated), 325 mg., bottles of 100, 200, 250, 500, and 1,000 count

D-002-2, Aspirin tablets (coated), 325 mg., bottles of 100, 200, 250, 300, 500, and 1,000 count, and bulk drums of 50,000

Both types of tablets, coated and uncoated were produced under York's label and numerous private labels as follows:

Uncoated:
1. York Aspirin, 100-ct., 200-ct., 500-ct. and 1,000-ct.,
responsible firm: York Pharmaceuticals, Inc., Kansas City, KS
2. York Aspirin Russian label, 100-ct., responsible firm: York Pharmaceuticals, Inc., Kansas City, KS, or York Pharmaceutical Co., Brookfield, MO
3. Health Care Aspirin, 100-ct. and 200-ct., responsible firm: Great Lakes Sales, Wyoming, MI
4. Homebest Aspirin, 100-ct. and 250-ct., responsible firm: Glendale Foods, Inc., Hazelwood, MO
5. DG Aspirin (Dollar General on case label only), 200-ct. and 500-ct., responsible firm: Dolgencorp, Inc., Scottsville, KY
6. Aspirin, 1,000-ct. (Vitatrade on case label only),
responsible firm: Catholic Medical Mission Board, New York, NY
7. HyTop Aspirin, 100-ct. and 250-ct., responsible firm:
Federated Group, Arlington Heights, IL
8. Parade Aspirin, 250-ct. and 500-ct., responsible firm:
Federated Group, Arlington Heights, IL

Coated:
1. York Aspirin Analgesic Lite-Coat, 100-ct. and 200-ct.,
responsible firm: York Pharmaceuticals, Inc., Kansas City,KS
2. Parade Micro Coated Aspirin, 100-ct., 250-ct. and 500-ct., responsible firm: Federated Group, Arlington Heights, IL
3. HyTop Coated Aspirin, 100-ct. and 250-ct., responsible firm Federated Group, Arlington Heights, IL
4. Smart Choice Lite-Coat Aspirin, 100-ct., responsible firm: National Distribution Network, Merrick, NY
5. Our Family Coated Aspirin, 100-ct., 300-ct., and 500-ct., responsible firm: Nash Finch Company, Minneapolis, MN
6. Welby Lightly Coated Aspirin, 200-ct., responsible firm: Aldi, Inc., Batavia, IL
7. DeMoulas Market Basket Aspirin Film Coated, 100-ct. and 500-ct., responsible firm: Demoulas & Market Basket Stores,Tewksbury, MA
8. Southern Home Aspirin Coated Regular Strength, 100-ct. and 300-ct., responsible firm: Southern Home, Birmingham, AL
9. Quality Choice Micro Thin Coating Aspirin, 100-ct., responsible firm: Quality Choice, Novi, MI
10. Snyder Micro Coated Aspirin, 100-ct., 300-ct., 500-ct., and 1,000-ct., responsible firm: Snyder's Drug Stores, Inc., Minnetonka, MN
11. Navarro Lite Coat Aspirin, 100-ct., 250-ct. and 500-ct., responsible firm: Navarro Discount Pharmacies, Inc., Miami, FL
12. Conney Aspirin USP Lightly Coated, 100-ct. and 1,000-ct., responsible firm: Conney Safety Products Co., Inc., Madison, WI
13. Discount Drug Mart Food Fair Film Coated Aspirin, 200-ct., responsible firm: Drug Mart-Food Fair, Medina, OH
14. Medic Drug Coated Aspirin, 100-ct. and 250-ct., responsible firm: Medic Drug Co., Inc., Cleveland, OH
15. Vi-Jon Coated Aspirin, 100 ct., responsible firm: The ViJon Co., St. Louis, MO
16. Bulk aspirin 325 mg. tablets coated, 50,000-ct.

Codes:
Lot # Exp. Date Description
9909018 Sep 01 Conney 1,000 ct. Coated
9910089 Sep 01 HyTop 250 ct.
9911001 Sep 01 Dollar General 200 ct.
9910042 Sep 01 Parade 100 ct. Coated
0002036 Sep 01 Navarro 250 ct. Coated

9910033 Oct 01 Parade 100 ct. Coated
9910045 Oct 01 Smart Choice 100 ct. Coated
9910057 Oct 01 HyTop 100 ct.
9910073 Oct 01 HyTop 100 ct.
9910087 Oct 01 Russian 100 ct.
9910095 Oct 01 Russian 100 ct.
9910096 Oct 01 Russian 100 ct.
9910105 Oct 01 Russian 100 ct.
9910115 Oct 01 York 200 ct.
9910120 Oct 01 Dollar General 200 ct.
9911005 Oct 01 Dollar General 200 ct.
9911023 Oct 01 Homebest 250 ct.
9911035 Oct 01 Parade 250 ct.
9911048 Oct 01 Dollar General 500 ct.
9911061 Oct 01 Snyder 500 ct. Coated
9911067 Oct 01 Parade 100 ct. Coated
9911098 Oct 01 Health Care 100 ct.
9911161 Oct 01 York 100 ct.
9911174 Oct 01 York 100 ct. Coated
9912095 Oct 01 Dollar General 200 ct.
9912120 Oct 01 Dollar General 200 ct.
0002032 Oct 01 Parade 250 ct. Coated
0002131 Oct 01 Vitatrade 1,000 ct.

9911052 Nov 01 Dollar General 500 ct.
9911055 Nov 01 York 500 ct.
9911080 Nov 01 Homebest 100 ct.
9911081 Nov 01 Health Care 100 ct.
9911101 Nov 01 Health Care 200 ct.
9911116 Nov 01 Welby 200 ct. Coated
9911129 Nov 01 Welby 200 ct. Coated
9911140 Nov 01 Homebest 100 ct.
9911146 Nov 01 Our Family 500 ct. Coated
9911160 Nov 01 Parade 500 ct. Coated
9911180 Nov 01 Homebest 100ct.
9912003 Nov 01 Our Family 300 ct. Coated
9912004 Nov 01 Our Family 300 ct.
9912005 Nov 01 Snyder 300 ct. Coated
9912025 Nov 01 Southern Home 300 ct. Coated
9912030 Nov 01 Our Family 100 ct. Coated
9912031 Nov 01 Navarro 100 ct. Coated
9912040 Nov 01 Smart Choice 100 ct. Coated
9912054 Nov 01 Southern Home 100 ct. Coated
9912055 Nov 01 HyTop 100 ct. Coated
9912086 Nov 01 York 100 ct. Coated
9912126 Nov 01 Vitatrade 1,000 ct.
0001102 Nov 01 Southern Home 100 ct. Coated
0001109 Nov 01 York 100 ct. Coated
0002045 Nov 01 York 200 ct. Coated


9912044 Dec 01 Vitatrade 1,000 ct.
9912096 Dec 01 Welby 200 ct. Coated
9912130 Dec 01 Parade 250 ct.
9912141 Dec 01 Vitatrade 1,000 ct.
9912148 Dec 01 Welby 200 ct. Coated
9912150 Dec 01 Vitatrade 1,000 ct.
9912151 Dec 01 Vitatrade 1,000 ct.
9912158 Dec 01 Vitatrade 1,000 ct.
0001011 Dec 01 Dollar General 200 ct.
0001021 Dec 01 Dollar General 200 ct.
0001023 Dec 01 Dollar General 200 ct.
0001085 Dec 01 York 100 ct. Coated
0001105 Dec 01 Dollar General 500 ct.

9912063 Jan 02 Navarro 250 ct.
0001026 Jan 02 HyTop 250 ct.
0001027 Jan 02 York 200 ct.
0001056 Jan 02 HyTop 100 ct.
0001059 Jan 02 Health Care 100 ct.
0001103 Jan 02 York 100 ct. Coated
0001106 Jan 02 Dollar General 500 ct.
0001114 Jan 02 Parade 500 ct.
0001117 Jan 02 Parade 500 ct. Coated
0001118 Jan 02 Navarro 500 ct. Coated
0001126 Jan 02 Southern Home 100 ct. Coated
0001128 Jan 02 Snyder 500 ct. Coated
0001129 Jan 02 Dollar General 200 ct.
0002011 Jan 02 Dollar General 200 ct.
0002013 Jan 02 Our Family 500 ct. Coated
0002014 Jan 02 Our Family 500 ct. Coated
0002016 Jan 02 York 500 ct.
0002018 Jan 02 York 100 ct.
0002019 Jan 02 Drug Mart 200 ct. Coated
0002050 Jan 02 York 200 ct. Coated
0002053 Jan 02 Our Family 100 ct. Coated
0002058 Jan 02 York 200 ct. Coated
0002061 Jan 02 BULK COATED
0002122 Jan 02 Vitatrade 1,000 ct.
0002123 Jan 02 Vitatrade 1,000 ct.
0002124 Jan 02 Vitatrade 1,000 ct.

0002039 Feb 02 Our Family 300 ct.
0002060 Feb 02 Dollar General 200 Ct.
0002093 Feb 02 Southern Home 300 ct. Coated
0002096 Feb 02 Conney 100 ct. Coated
0002097 Feb 02 Snyder 100 ct. Coated
0002112 Feb 02 Vitatrade 1,000 ct.
0002115 Feb 02 Our Family 500 ct. Coated
0002136 Feb 02 Vitatrade 1,000 ct.
0002137 Feb 02 Snyder 300 ct. Coated
0002140 Feb 02 Vitatrade 1,000 ct.
0002141 Feb 02 Snyder 300 ct. Coated
0002148 Feb 02 Vitatrade 1,000 ct.
0002149 Feb 02 York 100 ct.
0002150 Feb 02 York 100 ct.
0002153 Feb 02 Vitatrade 1,000 ct.
0002158 Feb 02 Our Family 300 ct. Coated
0002161 Feb 02 Navarro 100 ct. Coated
0002163 Feb 02 Our Family 300 ct.
0003002 Feb 02 Homebest 250 ct.
0003007 Feb 02 HyTop 250 ct. Coated
0003030 Feb 02 Vitatrade 1,000 ct.
0003034 Feb 02 Medic 250 ct. Coated
0003040 Feb 02 Medic 250 ct. Coated

0003031 Mar 02 Dollar General 200 ct.
0003038 Mar 02 York 100 ct.
0003042 Mar 02 Vitatrade 1,000 ct.
0003050 Mar 02 Dollar General 200 ct.
0003054 Mar 02 Dollar General 200 ct.
0003063 Mar 02 Health Care 200 ct.
0003069 Mar 02 Dollar General 200 ct.
0003071 Mar 02 Dollar General 200 ct.
0003074 Mar 02 Smart Choice 100 ct. coated
0003081 Mar 02 Medic 100 ct. Coated
0003093 Mar 02 Our Family 100 ct. Coated
0003094 Mar 02 Our Family 300 ct. Coated
0003095 Mar 02 Our Family 300 ct.
0003096 Mar 02 Our Family 500 ct. Coated
0003097 Mar 02 Snyder 500 ct. Coated
0003106 Mar 02 York 1,000 ct.
0003107 Mar 02 Snyder 1,000 ct. Coated
0003111 Mar 02 BULK COATED
0003112 Mar 02 Health Care 100 ct.
0003114 Mar 02 York 1,000 ct.
0003119 Mar 02 Our Family 500 ct. Coated
0003121 Mar 02 York 100 ct.
0004008 Mar 02 York 100 ct.
0004012 Mar 02 York 100 ct.
0004015 Mar 02 Dollar General 200 ct.
0004016 Mar 02 York 200 ct.
0004019 Mar 02 Navarro 200 ct. Coated
0004021 Mar 02 York 100 ct.
0004025 Mar 02 York 200 ct.
0004026 Mar 02 York 100 ct.
0004027 Mar 02 HyTop 250 ct.
0004031 Mar 02 Navarro 100 ct. Coated

0004034 Apr 02 Welby 200 ct. Coated
0004036 Apr 02 HyTop 250 ct.
0004037 Apr 02 Our Family 100 ct. Coated
0004038 Apr 02 Dollar General 200 ct.
0004040 Apr 02 Navarro 100 ct. Coated
0004050 Apr 02 Dollar General 200 ct.
0004051 Apr 02 HyTop 100 ct.
0004052 Apr 02 Parade 100 ct. Coated
0004062 Apr 02 Parade 100 ct. Coated
0004067 Apr 02 Our Family 300 ct. Coated
0004068 Apr 02 York 100 ct.
0004069 Apr 02 York 100 ct.
0004073 Apr 02 Welby 200 ct. Coated
0004079 Apr 02 York 100 ct.
0004087 Apr 02 Welby 200 ct. Coated
0004096 Apr 02 Vitatrade 1,000 ct.
0004097 Apr 02 Vi-Jon 100 ct.
0004098 Apr 02 Dollar General 200 ct.
0004099 Apr 02 Our Family 300 ct. Coated
0004103 Apr 02 Dollar General 200 ct.
0005005 Apr 02 DeMoulas 500 ct. Coated
0005009 Apr 02 Our Family 300 ct.
0005035 Apr 02 Vitatrade 1,000 ct.

0004095 May 02 Our Family 500 ct. Coated
0005015 May 02 DeMoulas 100 ct. Coated
0005017 May 02 Our Family 300 ct.
0005034 May 02 HyTop 100 ct.
0005039 May 02 Vitatrade 1,000 ct.
0005047 May 02 Vitatrade 1,000 ct.
0005051 May 02 Vitatrade 1,000 ct.
0005058 May 02 Vitatrade 1,000 ct.
0005060 May 02 Vitatrade 1,000 ct.
0005062 May 02 Vijon 100 ct. Coated
0005067 May 02 Dollar General 200 ct.
0005080 May 02 BULK COATED
0005083 May 02 Dollar General 200 ct.
0005092 May 02 Dollar General 200 ct.
0005093 May 02 HyTop 100 ct.
0005094 May 02 York 100 ct.
0005097 May 02 Our Family 500 ct. Coated
0005098 May 02 York 500 ct.
0005104 May 02 Our Family 500 ct. Coated
0005128 May 02 Dollar General 200 ct.

0006004 Jun 02 Dollar General 200 ct.
0006009 Jun 02 Our Family 300 ct.
0006011 Jun 02 York 200 ct.
0006020 Jun 02 Dollar General 200 ct.
0006025 Jun 02 Southern Home 100 ct. Coated
0006026 Jun 02 Dollar General 200 ct.
0006027 Jun 02 York 100 ct.
0006032 Jun 02 HyTop 100 ct.
0006044 Jun 02 York 200 ct.
0006050 Jun 02 York 200 ct. Coated
0006056 Jun 02 Smart Choice 100 ct. Coated
0006057 Jun 02 Our Family 100 ct. Coated
0006069 Jun 02 Quality Choice Coated
0006072 Jun 02 Smart Choice 100 ct. Coated
0006075 Jun 02 Smart Choice 100 ct. Coated
0006077 Jun 02 BULK ASPIRIN KG
0006082 Jun 02 Snyder 1,000 ct. Coated
0006087 Jun 02 Russian 100 ct.
0006090 Jun 02 Vitatrade 1,000 ct.
0006091 Jun 02 Dollar General 200 ct.
0006093 Jun 02 Vitatrade 1,000 ct.
0006094 Jun 02 Vitatrade 1,000 ct.
0006095 Jun 02 Dollar General 200 ct.
0006097 Jun 02 Welby 200 ct. Coated
0006098 Jun 02 Our Family 500 ct. Coated
0006099 Jun 02 Vitatrade 1,000 ct.
0006103 Jun 02 York 1,000 ct.
0006105 Jun 02 Vitatrade 1,000 ct.
0006109 Jun 02 Navarro 500 ct. Coated
0006110 Jun 02 Welby 200 ct. Coated
0006111 Jun 02 Vitatrade 1,000 ct.
0006112 Jun 02 Vitatrade 1,000 ct.
0006118 Jun 02 Dollar General 200 ct.

0007010 Jul 02 Navarro 250 ct. Coated
0007012 Jul 02 Dollar General 200 ct.
0007014 Jul 02 Russian 100 ct.
0007024 Jul 02 Russian 100 ct.
0007027 Jul 02 Russian 100 ct.
0007030 Jul 02 Russian 100 ct.
0007035 Jul 02 Russian 100 ct.

0008068 Aug 02 York 100 ct.
0008087 Aug 02 York 200 ct.

0012055 Dec 02 Dollar General 200 ct.
0012074 Dec 02 Health Care 200 ct.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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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.