FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and
Drug Administration, Department of Health and Human Services.
It contains information on actions taken in connection with agency
Regulatory activities.
October 31, 2001 01-43
***CORRECTION*** Recall F-002-2 (Reported in Enforcement Report
01-41 dated 10/17/01) and F-026-1 (Reported in Enforcement Report 01-42
dated 10/24/01) was completed recall from an inspection and analysis by
the New York State Department Agriculture and Markets.
***CORRECTION***The D-316-1 recall as reported in Enforcement Report #01-
41, dated 10/17/01, was incorrectly reported as being manufactured by PL
Developments. PL Developments was the repacker/ recalling firm and PDK
Labs of Hauppauge, NY was the manufacturer of the bulk tablets.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________________
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.
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-003-2, OxyContin, (oxycodone hydrochloride controlled-release) tablets,
10 mg. Rx Only, Dist. by Purdue Pharma L.P., Norwalk, CT 06850, Packaged
in units of 25 and 100 tablets.
D-004-2, OxyContin, (oxycodone hydrochloride controlled-release) tablets,
20 mg. Rx Only, Dist. by Purdue Pharma L.P., Norwalk, CT 06850, Packaged
in units of 25 and 100 tablets.
D-005-2, OxyContin, (oxycodone hydrochloride controlled-release) tablets,
40 mg. Rx Only, Dist. by Purdue Pharma L.P., Norwalk, CT 06850, Packaged
in units of 25 and 100 tablets.
D-006-2, OxyContin, (oxycodone hydrochloride controlled-release) tablets,
80 mg. Rx Only, Dist. by Purdue Pharma L.P., Norwalk, CT 06850, Packaged
in units of 25 and 100 tablets.
D-007-2, OxyContin, (oxycodone hydrochloride controlled-release) tablets,
160 mg. Rx Only, Dist. by Purdue Pharma L.P., Norwalk, CT 06850,
Packaged in units of 25 and 100 tablets.
There are 388 batches of OxyContin, 10, 20, 40, 80, 160mg Tablets:
10 mg Tablets:
9L91, EXP 28-FEB-05
9M11, EXP 28-FEB-05
9M21, EXP 28-FEB-05
AE81, EXP 31-DEC-04
AE91, EXP 31-DEC-04
AF01, EXP 31-DEC-04
AF81, EXP 31-DEC-04
AF91, EXP 31-DEC-04
AG21, EXP 31-DEC-04
AH41, EXP 28-FEB-05
AH51, EXP 28-FEB-05
AH61, EXP 28-FEB-05
AJ61, EXP 31-JAN-05
AJ71, EXP 31-JAN-05
AJ81, EXP 31-JAN-05
AW81, EXP 31-JAN-05
AW91, EXP 31-JAN-05
AY01, EXP 28-FEB-05
AY11, EXP 28-FEB-05
AY21, EXP 28-FEB-05
AY31, EXP 28-FEB-05
AY41, EXP 28-FEB-05
AY51, EXP 28-FEB-05
AX01, EXP 31-JAN-05
AX04, EXP 31-JAN-05
2L61, EXP 30-NOV-03
2L71, EXP 31-DEC-03
2L81, EXP 31-DEC-03
2W11, EXP 31-DEC-03
2W21, EXP 31-DEC-03
2W31, EXP 31-DEC-03
2Y41, EXP 31-DEC-03
2Y61, EXP 31-DEC-03
2Y71, EXP 31-DEC-03
2Y81, EXP 31-DEC-03
3E51, EXP 31-DEC-03
3E61, EXP 31-JAN-04
CX51, EXP 30-APR-05
CX61, EXP 30-APR-05
WA431, EXP 30-APR-05
WA561, EXP 30-APR-05
WA571, EXP 30-APR-05
8G21, EXP 31-OCT-04
8S1N1, EXP 31-OCT-04
8S2N1, EXP 30-NOV-04
8S9N1, EXP 30-SEP-04
8T0N1, EXP 30-SEP-04
8T1N1, EXP 30-SEP-04
8X31, EXP 31-OCT-04
8X41, EXP 31-OCT-04
8X51, EXP 31-OCT-04
8X91, EXP 30-SEP-04
8Y01, EXP 30-SEP-04
8Y11, EXP 30-SEP-04
9E41, EXP 31-OCT-04
9E51, EXP 31-OCT-04
9E61, EXP 31-OCT-04
9E71, EXP 30-NOV-04
9E81, EXP 30-NOV-04
9K1N1, EXP 31-OCT-04
9K3N1, EXP 31-OCT-04
9P7N1, EXP 30-NOV-04
9P8N1, EXP 30-NOV-04
9P9N1, EXP 30-NOV-04
9R4N1, EXP 30-NOV-04
9R5N1, EXP 30-NOV-04
9S5N1, EXP 30-NOV-04
9S6N1, EXP 30-NOV-04
9S7N1, EXP 30-NOV-04
9V4N7, EXP 30-NOV-04
9W2N1, EXP 30-NOV-04
9E91, EXP 30-NOV-04
9R61, EXP 30-NOV-04
9R62, EXP 30-NOV-04
20mg Tablets:
9R21, EXP 30-NOV-04
9W01, EXP 30-NOV-04
AD62, EXP 31-DEC-04
AD71, EXP 31-DEC-04
AD81, EXP 31-DEC-04
AF11, EXP 31-DEC-04
AF21, EXP 31-DEC-04
AF31, EXP 31-DEC-04
AG81, EXP 31-DEC-04
AG91, EXP 31-DEC-04
AH01, EXP 31-DEC-04
AJ01, EXP 31-DEC-04
AJ11, EXP 31-DEC-04
AJ21, EXP 31-DEC-04
AK21, EXP 31-JAN-05
AK31, EXP 31-JAN-05
AK41, EXP 31-JAN-05
AW51, EXP 31-JAN-05
AW61, EXP 31-JAN-05
AW71, EXP 31-JAN-05
AX31, EXP 31-JAN-05
AX41, EXP 31-JAN-05
BB1N1, EXP 28-FEB-05
BB2N1, EXP 28-FEB-05
BB3N1, EXP 28-FEB-05
AX54, EXP 31-JAN-05
2L2N1, EXP 31-DEC-03
2L3N1, EXP 31-DEC-03
2L4N1, EXP 31-DEC-03
2M11, EXP 30-NOV-03
2M2N2, EXP 30-NOV-03
2M3N1, EXP 30-NOV-03
2M4N2, EXP 30-NOV-03
2M5N1, EXP 31-DEC-03
2T91, EXP 31-DEC-03
2V01, EXP 31-DEC-03
2V11, EXP 31-DEC-03
2W41, EXP 31-DEC-03
2W51, EXP 31-DEC-03
2W61, EXP 31-DEC-03
2X41, EXP 31-DEC-03
2X51, EXP 31-DEC-03
2X61, EXP 31-JAN-04
2X71, EXP 31-DEC-03
2X72, EXP 31-DEC-03
2X81, EXP 31-DEC-03
2X91, EXP 31-DEC-03
2Y01, EXP 31-JAN-04
2Y11, EXP 31-JAN-04
BX71, EXP 30-APR-05
BX81, EXP 30-APR-05
BX91, EXP 30-APR-05
CR61, EXP 31-MAR 05
CR71, EXP 31-MAR-05
CR81, EXP 31-MAR-05
CR91, EXP 30-APR-05
CS01, EXP 30-APR-05
CS11, EXP 30-APR-05
CY11, EXP 30-APR-05
CY21, EXP 30-APR-05
CY31, EXP 30-APR-05
CY41, EXP 30-APR-05
CY51, EXP 30-APR-05
CY61, EXP 30-APR-05
CY71, EXP 30-APR-05
CY81, EXP 30-APR-05
CY91, EXP 30-APR-05
WA401, EXP 30-APR-05
WA411, EXP 30-APR-05
8R1N1, EXP 31-0CT-04
8R2N1, EXP 31-0CT-04
8R3N1, EXP 31-0CT-04
8S31, EXP 31-OCT-04
8S41, EXP 31-OCT-04
8S51, EXP 31-OCT-04
8S61, EXP 31-OCT-04
8S71, EXP 30-NOV-04
8T21, EXP 30-SEP-04
8T31, EXP 30-SEP-04
8T41, EXP 30-SEP-04
8T51, EXP 30-SEP-04
8T61, EXP 30-SEP-04
8T7N1, EXP 31-OCT-04
8T8N1, EXP 30-NOV-04
8T9N1, EXP 30-NOV-04
8X6N1, EXP 30-NOV-04
8X71, EXP 31-OCT-04
8X81, EXP 30-NOV-04
9C31, EXP 31-0CT-04
9C41, EXP 31-OCT-04
9C51, EXP 31-0CT-04
9C91, EXP 31-OCT-04
9D01, EXP 31-OCT-04
9J51, EXP 31-OCT-04
9J61, EXP 31-OCT-04
9J71, EXP 31-OCT-04
9J8N1, EXP 31-OCT-04
9J9N1, EXP 31-OCT-04
9K0N1, EXP 31-OCT-04
9L6N1, EXP 30-NOV-04
9L7N1, EXP 30-NOV-04
9L8N1, EXP 30-NOV-04
9R0N1, EXP 30-NOV-04
9R1N1, EXP 30-NOV-04
9S1N7, EXP 30-NOV-04
9S8N1, EXP 30-NOV-04
9S9N1, EXP 30-NOV-04
9T0N1, EXP 30-NOV-04
9T7N1, EXP 30-NOV-04
9T8N1, EXP 30-NOV-04
9T9N1, EXP 30-NOV-04
9D11, EXP 31-OCT-04
40mg Tablets:
9L31, EXP 31-DEC-04
9V1N1, EXP 30-NOV-04
9V2N1, EXP 30-NOV-04
9V3N1, EXP 30-NOV-04
9W11, EXP 31-DEC-04
AD91, EXP 31-DEC-04
AE01, EXP 31-DEC-04
AE11, EXP 31-DEC-04
AF41, EXP 31-DEC-04
AF51, EXP 31-DEC-04
AF61, EXP 31-DEC-04
AG51, EXP 31-DEC-04
AG61, EXP 31-DEC-04
AG71, EXP 31-DEC-04
AH11, EXP 31-DEC-04
AH21, EXP 31-DEC-04
AH31, EXP 31-DEC-04
AJ91, EXP 31-JAN-05
AX81, EXP 31-JAN-05
AX91, EXP 31-JAN-05
AY61, EXP 28-FEB-05
AY9N1, EXP 31-JAN-05
BA0N1, EXP 31-JAN-05
BA1N1, EXP 28-FEB-05
BA2N1, EXP 31-JAN-05
BA3N1, EXP 31-JAN-05
BA4N1, EXP 31-JAN-05
BD01, EXP 28-FEB-05
BD11, EXP 28-FEB-05
BD21, EXP 28-FEB-05
AK01, EXP 31-JAN-05
2M9N1, EXP 31-DEC-03
2V21, EXP 31-DEC-03
2V31, EXP 31-DEC-03
2V41, EXP 31-DEC-03
2V81, EXP 31-DEC-03
2V91, EXP 31-DEC-03
2W01, EXP 31-DEC-03
2W71, EXP 31-DEC-03
2W81, EXP 31-DEC-03
2W91, EXP 31-JAN-04
CS21, EXP 30-APR-05
CS31, EXP 30-APR-05
CS41, EXP 30-APR-05
CS51, EXP 30-APR-05
CS61, EXP 30-APR-05
CS71, EXP 30-APR-05
8V0N1, EXP 31-OCT-04
8V1N1, EXP 31-OCT-04
8V2N1, EXP 31-OCT-04
8V41, EXP 30-SEP-04
8V51, EXP 30-SEP-04
8V61, EXP 30-SEP-04
8V91, EXP 30-SEP-04
8W01, EXP 30-SEP-04
8W1N1, EXP 31-OCT-04
8W41, EXP 30-SEP-04
8W51, EXP 31-OCT-04
8W61, EXP 31-OCT-04
8W71, EXP 31-OCT-04
8W81, EXP 31-OCT-04
8W91, EXP 31-OCT-04
9C01, EXP 31-OCT-04
9C11, EXP 31-OCT-04
9C21, EXP 31-OCT-04
9D51, EXP 31-OCT-04
9D61, EXP 31-OCT-04
9D71, EXP 31-OCT-04
9D81, EXP 31-OCT-04
9D91, EXP 31-OCT-04
9E01, EXP 31-OCT-04
9K41, EXP 31-OCT-04
9K51, EXP 31-OCT-04
9K61, EXP 31-OCT-04
9L0N1, EXP 31-OCT-04
9L11, EXP 31-OCT-04
9L21, EXP 31-OCT-04
9L4N1, EXP 30-NOV-04
9L5N1, EXP 30-NOV-04
9R7N1, EXP 30-NOV-04
9T1N1, EXP 30-NOV-04
9T2N1, EXP 30-NOV-04
9T3N5, EXP 30-NOV-04
AX71, EXP 31-JAN-05
9D52, EXP 31-OCT-04
80mg Tablets:
9T4N1, EXP 30-NOV-04
9T5N1, EXP 30-NOV-04
9T6N1, EXP 30-NOV-04
9V8N1, EXP 31-DEC-04
9V91, EXP 31-DEC-04
AE51, EXP 31-DEC-04
AE61, EXP 31-DEC-04
AE71, EXP 31-DEC-04
AF71, EXP 31-DEC-04
AG01, EXP 31-DEC-04
AG11, EXP 31-DEC-04
AH71, EXP 31-DEC-04
AH81, EXP 31-DEC-04
AH91, EXP 31-DEC-04
AJ31, EXP 31-DEC-04
AJ41, EXP 31-DEC-04
AJ51, EXP 31-JAN-05
AL11, EXP 31-JAN-05
AL21, EXP 31-JAN-05
AL31, EXP 31-JAN-05
AX61, EXP 28-FEB-05
BA51, EXP 28-FEB-05
BA61, EXP 28-FEB-05
BA71, EXP 28-FEB-05
BA81, EXP 28-FEB-05
AE52, EXP 31-DEC-04
2L5N1, EXP 31-DEC-02
2V61, EXP 31-DEC-02
2V71, EXP 31-DEC-02
2X01, EXP 31-DEC-02
2X11, EXP 31-JAN-03
2X21, EXP 31-JAN-03
CK81, EXP 31-MAR-05
CK91, EXP 31-MAR-05
CL01, EXP 31-MAR-05
CL11, EXP 30-APR-05
WA581, EXP 30-APR-05
WA591, EXP 30-APR-05
WA601, EXP 30-APR-05
8P8N1, EXP 31-OCT-04
8P9N1, EXP 31-OCT-04
8R0N1, EXP 31-OCT-04
8V3N1, EXP 31-OCT-04
8V71, EXP 30-SEP-04
8V81, EXP 30-SEP-04
8W2N1, EXP 30-SEP-04
8W31, EXP 31-OCT-04
8X01, EXP 31-OCT-04
8X11, EXP 31-OCT-04
8X21, EXP 31-OCT-04
9C61, EXP 31-OCT-04
9C71, EXP 31-OCT-04
9C81, EXP 31-OCT-04
9D31, EXP 31-OCT-04
9D41, EXP 31-OCT-04
9E11, EXP 31-OCT-04
9E2N1, EXP 31-OCT-04
9E3N1, EXP 31-OCT-04
9K71, EXP 31-OCT-04
9K81, EXP 31-OCT-04
9K91, EXP 31-OCT-04
9S2N1, EXP 30-NOV-04
9S3N1, EXP 30-NOV-04
9S4N1, EXP 30-NOV-04
160mg Tablets:
9R31, EXP 30-NOV-03
9V51, EXP 30-NOV-03
9V61, EXP 30-NOV-03
AG31, EXP 31-DEC-03
AG41, EXP 31-DEC-03
AX11, EXP 31-JAN-04
AX21, EXP 31-JAN-04
8S81, EXP 30-SEP-03
9D21, EXP 31-OCT-03
REASON:
Contamination- tablets contain particles of stainless steel and/or were
manufactured with an unqualified excipient
MANUFACTURER/RECALLING FIRM:
The P.F. Laboratories, Inc., Totowa, NJ
RECALLED BY:
Purdue Pharma L.P., Stamford, CT, via letter on September 12, 2001.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
Nationwide and Argentina, Bolivia, Brazil, Central America, Mexico,
Norway, and Peru
QUANTITY:
3,388,083 bottles of 100's and 257,797 blisters of 25
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
B-0119-2, Red Blood Cells, Deglycerolized, Unit 0535732
REASON:
Blood product, deglycerolized with an expired reagent, was distributed.
MANUFACTURER/RECALLING FIRM:
Hoxworth Blood Center, Cincinnati, Ohio
RECALLED BY:
The recalling firm by telephone on December 4, 2000 and by letter dated
February 2, 2001
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
OH
QUANTITY:
1 unit
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
B-0122-2, Source Leukocytes, Unit 06GW41751
B-0123-2, Recovered Plasma, Unit 06GW41751, 06LC56047
REASON:
Blood products collected from a donor with a history of having tested
positive for hepatitis B core antigen (anti-HBc) were distributed.
MANUFACTURER/RECALLING FIRM:
American Red Cross, Los Angeles, CA
RECALLED BY:
The recalling firm by fax dated July 7, 2000.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
CA and Switzerland
QUANTITY:
3 units
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
B-0125-2, Red Blood Cells, Leukoreduced, Units 13FH86285, 13FH86291,
13FH86292, 13FH96293, 13FH86297, 13FN67432.
B-0126-2, Platelets, Units 13FH86285, 13FH86291, 13FH86292, 13FH96293,
13FH86297, 13FN67432
B-0127-2, Recovered Plasma, Units 13FH96293 and 13FN67432
REASON:
A unit of pooled Platelets, Leukoreduced, which was implicated in a
transfusion reaction, found to be contaminated with Staphylococcus
epidermidis.
MANUFACTURER/RECALLING FIRM:
American Red Cross, Detroit, Michigan
RECALLED BY:
The recalling firm by telephone or fax on July 6, 2001 or by letter on
July 21, 2001
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
MI and CA
QUANTITY:
14 units
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
B-0138-2, Red Blood Cells, Units 36260-7641 and 36261-7605
REASON:
Blood products, collected from an unsuitable donor based on travel to an
area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM:
Blood Systems, Inc., Ventura, CA
RECALLED BY:
Blood Systems, Inc., Scottsdale, AZ, notified by letter dated August 10,
2001.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
CA
QUANTITY:
2 units
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
B-0139-2, Red Blood Cells, Units GJ65879 and GJ62497
REASON:
Blood products, collected from an unsuitable donor based on travel to an
area considered endemic for malaria, were distributed.
MANUFACTURER/RECALLING FIRM:
Tri-Counties Blood Bank, Santa Barbara, CA
RECALLED BY:
Blood Systems, Inc., Scottsdale, AZ, by letter dated August 8, 2000.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
CA
QUANTITY:
2 units
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
B-0140-2, Platelets Pheresis, Unit 07FP10490
REASON:
Platelets with an elevated platelet count were distributed.
MANUFACTURER/RECALLING FIRM:
The American National Red Cross, Tucson, AZ
RECALLED BY:
The recalling firm by telephone on June 30, 2001
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
AZ
QUANTITY:
1 unit
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
B-0120-2, Red Blood Cells, Leukoreduced, Irradiated, Unit 03GG73910
REASON:
Blood product, which were stored at unacceptable temperatures, was
distributed.
MANUFACTURER/RECALLING FIRM:
American Red Cross, Atlanta, GA
RECALLED BY:
The recalling firm by letter dated January 10, 2001.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
GA
QUANTITY:
1 unit
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
B-0141-2, Red Blood Cells, Leukocytes Reduced, Units 36262-1187 and
36262-1191
REASON:
Blood products that were out of controlled storage for more than 30
minutes were distributed.
MANUFACTURER/RECALLING FIRM:
Blood Systems, Inc., Ventura, CA
RECALLED BY:
Blood Systems, Inc., Scottsdale, AZ, by telephone on July 12, 2001
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
CA
QUANTITY:
2 units
______________________________
RECALL NUMBER, PRODUCT AND CODE:
B-0142-2, Red Blood Cells, Pheresis, Unit GJ80527
B-0143-2, Red Blood Cells, Pheresis, Leukocytes Reduced, Unit GJ80563
REASON:
Blood products, collected on an apheresis machine where there was no
documentation of evaluation of the filter assemblies as required, were
distributed.
MANUFACTURER/RECALLING FIRM:
Tri-Counties Blood Bank, Santa Barbara, CA
RECALLED BY:
Blood Systems, Inc., Scottsdale, AZ, by letter dated June 14, 2001
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
CA
QUANTITY:
2 units
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
B-0144-2, Red Blood Cells, Pheresis, Units GJ72711, GJ73965, and GK15229
REASON:
Blood products, collected on an apheresis machine where there was no
documentation of evaluation of the filter assemblies as required, were
distributed.
MANUFACTURER/RECALLING FIRM:
Tri-Counties Blood Bank, Santa Barbara, CA
RECALLED BY:
Blood Systems, Inc., Scottsdale, AZ by letter dated February 8, 2001
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
CA
QUANTITY:
3 units
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
Z-0179-2/Z-0180-2, MTI FlowRider, Flow Directed Micro Catheter.
Codes:
Model Lot Exp Date
105-5060 650514J June 2003
105-5063 650524J June 2003
105-5063 660224J June 2003
105-5063 660294J July 2003
REASON:
Catheter lumen obstructed.
MANUFACTURER/RECALLING FIRM:
Micro Therapeutics, Inc., Irvine, CA
RECALLED BY:
Manufacturer, by letter on August 18, 2000.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
NY and Australia, Austria, Denmark, Finland, Japan, Korea, Turkey,
United Kingdom, France, Germany, Italy, Spain and Switzerland
QUANTITY:
332
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
Z-0181-2, Marconi MX8000 Computed Tomography X-ray System, Codes: All
Marconi MX8000 CT Scanners, running with Version 2.0 and 2.01 software.
REASON:
Software in version 2.0 / 2.01 software may lead to improper patient
treatment.
MANUFACTURER/RECALLING FIRM:
Marconi Medical Systems, Inc., Highland Heights, OH
RECALLED BY:
The firm, by letter dated 11/7/2000
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
Nationwide and Worldwide
QUANTITY:
150 (76 domestic)
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
Z-0183-2/Z-0195-2, Medronic malleable single stage venous cannula.
A) Medtronic DLP 12 Fr Malleable single stage venous cannula,
Code: 68112, lot number: 200104P025
B) Medtronic DLP 14 Fr Malleable single stage venous cannula,
Code: 68114, lot number: 200103P092
C) Medtronic DLP 16 Fr Malleable single stage venous cannula,
Code: 68116, lot number: 2001060028
D) Medtronic DLP 18 Fr Malleable single stage venous cannula,
Code: 68118, lot number: 200103P085
E) Medtronic DLP 20 Fr Malleable single stage venous cannula,
code: 68120, lot number: 200102P022
F) Medtronic DLP 22 Fr Malleable single stage venous cannula,
Code: 68122, lot number: 200104O052
G) Medtronic DLP 24 Fr Malleable single stage venous cannula,
Code: 68124, lot number: 2001060019
H) Medtronic DLP 26 Fr Malleable single stage venous cannula,
Code: 68126, lot number: 200102P010
I) Medtronic DLP 28 Fr Malleable single stage venous cannula,
Code: 68128, lot number: 200105P001 and 200105P002
J) Medtronic DLP 30 Fr Malleable single stage venous cannula,
Code: 68130, lot numbers: 200105P003
K) Medtronic DLP 32 Fr Malleable single stage venous cannula,
Code: 68132, lot numbers: 2001060024, 2001070027 and
2001070150
L) Medtronic DLP 34 Fr Malleable single stage venous cannula,
Code: 68134. lot number: 200105P010
M) Medtronic DLP 36 Fr Malleable single stage venous cannula,
Code: 68136. lot number: 2001060025
REASON:
Guide wire may break through cannula wall and 1 lot labeled with
incorrect size.
MANUFACTURER/RECALLING FIRM:
Medtronic Cardiac Surgical Products, Grand Rapids, MI
RECALLED BY:
Recalling firm, by letter on August 14, 2001.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
Nationwide, and Australia, Canada and the Netherlands
QUANTITY:
2056
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
Z-0197-2, Premier HSV-1 IgM ELISA, a diagnostic test kit for the
detection of IgM antibody to Herpes Simplex Virus Type 1 in human
serum.
Codes:
Lot Number: H1E150.010
Catalog Number: H1E150
REASON:
The test kit may exhibit false positive test results.
MANUFACTURER/RECALLING FIRM:
Meridian Diagnostics, Inc., Cincinnati, OH
RECALLED BY:
Recalling firm by letter dated 1/4/2001 and by telephone on 1/20/2001.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
Nationwide
QUANTITY:
384 kits
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
Z-0198-2/Z-0201-2, Invacare Mobilare Concentrators, 5 Liter,
Codes: Serial Numbers: 94K thru 94L, 95A thru 95L, 96A thru 96L,
and 97A.
REASON:
A faulty capacitor may fail and cause the unit to overheat and damage
the concentrator. There is a potential fire hazard.
MANUFACTURER/RECALLING FIRM:
Invacare Corp., Sanford, FL
RECALLED BY:
Invacare Corp., Elyria, OH, by letter on 8/31/2001.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
Nationwide and Worldwide
QUANTITY:
147,458
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
Z-0202-2, SSA-340A Optional Biopsy adaptor UAGV015A for Endovaginal
probe, Codes: Model number UAGV015A.
REASON:
Biopsy probe adaptor fork breaks, risk of vaginal damage.
MANUFACTURER/RECALLING FIRM:
Toshiba America Medical Systems, Inc., Tustin, CA
RECALLED BY:
Recalling firm issued letters on 1/11/2001.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
Nationwide and Puerto Rico
QUANTITY:
92
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
Z-0204-2, FlexiLab Laboratory Information System, Anatomic Pathology
Pathologist Workstation, Codes: Versions 3.0.7.2, 3.0.9.1 and 3.0.10.1.
REASON:
Data on one patient's pathology file overwrites to another patient's
file.
MANUFACTURER/RECALLING FIRM:
Sunquest Information Systems, Inc., Tucson, AZ
RECALLED BY:
Recalling firm, by letters on 11/21/2000 and 2/22/2001.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
Nationwide and Canada, Ireland, United Kingdom and Saudi Arabia.
QUANTITY:
102
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
Z-0205-2/Z-0212-2, Bayer brand Clinitek 50 Urine Chemistry Analyzer.
Analyzer catalog numbers 6510A, 6513, 6514, 6514C, 6515, 6515C, 6516
and 6516C. Codes: Serial numbers 150424 through 153031.
REASON:
Erratic results if plugged into an ungrounded outlet
MANUFACTURER/RECALLING FIRM:
Bayer Corp., Mishawaka, IN
RECALLED BY:
Bayer Corp., Elkhart, IN, by letter dated September 21, 2001.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
Nationwide and Worldwide
QUANTITY:
2,572
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
Z-0182-2, The device is a hand piece drill used in oral surgery. It is
labeled in part: "Osteomed OsteoPower Handpiece System 1:1 Straight
Drill," Codes: Lot numbers: 011352, 011855, 011939, 12079, 012080,
012486, 012487
REASON:
Corrosion stress failure may prevent collet from locking burr in place.
MANUFACTURER/RECALLING FIRM:
Osteomed Corp., Addison, TX
RECALLED BY:
Manufacturer, by letter dated 8/15/01.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
Nationwide and Italy, Spain and Canada
QUANTITY:
239
_______________________________
RECALL NUMBER, PRODUCT AND CODE:
Z-0196-2, ImmunoCard Toxin A, a rapid enzyme immunoassay for the
detection of Clostridium difficile Toxin A in human stool,
Codes: The following 24 Lot Numbers were recalled:
LOT NO. EXP DATE LOT NO. EXP DATE
711050.125 9/23/00 711050.126 9/23/00
711050.127 9/23/00 711050.128 11/11/00
711050.129 11/11/00 711050.130 11/11/00
711050.131 11/11/00 711050.132 11/11/00
711050.133 11/25/00 711050.134 12/14/00
711050.135 12/14/00 711050.136 1/28/01
711050.137 1/28/01 711050.138 1/28/01
711050.139 12/14/00 711050.140 3/08/01
711050.141 3/08/01 711050.156 8/17/01
711050.157 8/17/01 711050.160 8/17/01
711050.161 8/17/01 711050.162 8/17/01
711050.163 8/17/01 711050.165 9/16/01
711050.166 9/16/01 711050.167 9/16/01
REASON:
The substrate exhibits a blue color that may result in a false positive
test.
MANUFACTURER/RECALLING FIRM:
Meridian Diagnostics, Inc., Cincinnati, OH
RECALLED BY:
Recalling firm, by telephone and letter on 1/4/2001 with additional
letters dated 1/29/2001 and 2/10/2001.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
Nationwide and Canada, New Zealand, Venezuela, Costa Rica, and
Argentina
QUANTITY:
4252 kits
END OF ENFORCEMENT REPORT FOR OCTOBER 31, 2001.
####
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Hypertext uploaded by tg 2001-OCT-31.