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.

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November 9, 2005
05-45

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS II

______________________________
PRODUCT
Sea Best Brand, Basa, 12/1 lb retail bag vacuum packed. Product code number 7700705. Product of Vietnam (Farm Raised***Net Wt. 12 lbs (5.44 Kg), Recall # F-018-6
CODE
Lot number: 672120
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beaver Street Fisheries, Inc., Jacksonville, FL, by letters on September 2, 2005.
Manufacturer: Qvd Food Co. Ltd, Ho Chi Minh, Vietnam. Firm initiated recall is ongoing.
REASON
Potential risk of adverse health events due to consuming fluoroquinolone antibiotic residues in basa.
VOLUME OF PRODUCT IN COMMERCE
25,656 lbs
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Frozen Tuna Loins, 50 lbs./box. The product is packaged in a brown cardboard box with labeling on 1 end panel only. No labeling appears on packaging inside of the box. Frozen tuna loins are packaged in plastic, 6 to 8 packages/box. Labeled in part as “FZ. TUNA Loins PS ***Product of Costa Rica.***(wild caught), Net Wt. 50 Lbs, Recall # F-019-6
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alfa International Seafood, Inc., Miami, FL, by telephone beginning on March 8, 2005 .
Manufacturer: Expun S. A., San Jose, Costa Rica. Firm initiated recall is ongoing.
REASON
The product was associated with illness and was found to contain elevated levels of histamine.
VOLUME OF PRODUCT IN COMMERCE
8,150 lbs
DISTRIBUTION
Eastern U.S. and Canada

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Nitroglycerin Tablets, USP 0.4mg (1/150gr), 100 Sublingual Tablets (4 bottles of 25 tablets each), Rx Only, NDC 50111-989-59, Recall # D-013-6
CODE
Lot 101105 exp. 1/07; Lot 201105 exp. 1/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pliva, Inc., East Hanover, NJ, by letters on September 19, 2005.
Manufacturer: Concord Laboratories, Inc., Fairfield, NJ. Firm initiated recall is ongoing.
REASON
Defective container; caps on bottles are loose which can impact product integrity.
VOLUME OF PRODUCT IN COMMERCE
25,038 bottles
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Benazepril Hydrochloride Tablets, 40 mg, 100-tablet bottles, ETHEX brand, Rx only, NDC 58177-344-04, Recall # D-014-6
CODE
Lot #62794, Exp. 11/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethex Corporation, Bridgeton, MO, by letters dated September 21, 2005 and issued via e-mail on September 22, 2005.
Manufacturer: KV Pharmaceutical Co., St. Louis, MO. Firm initiated recall is ongoing.
REASON
Presence of Foreign Tablet; bottle found to contain Hyoscyamine Sulfate Extended-release Tablet.
VOLUME OF PRODUCT IN COMMERCE
13,076/100-tablet bottles
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) GoodSense brand Milk of Magnesia (magnesium hydroxide)
400 mg, Oral Liquid, Original Flavor, in 12 and 26 FL
OZ bottles, Distributed by Perrigo Co., Allegan,
Michigan, NDC 0113-0396-40 ---- Product is distributed
under the following brand names: Best Yet brand, C&S
Wholesale Grocers, Inc, Brattleboro, VT; Brite-Life
brand, Bergen Brunswig Drug Company, Orange, CA,
NDC 24385-396-40; CVS Pharmacy brand, Woonsocket, RI;
EckeRxd brand, Eckerd Drug Co., Clearwater, FL,
NDC 19458-3964-3; Equaline brand, Albertsons, Inc.,
Boise, ID, NDC 41163-396-35 and 41163-396-40; Equate
brand, Wal-Mart Stores, Inc, Bentonville, AR,
NDC 49035-396-35; Family Pharmacy brand, Family
Pharmacy, Southeastern, PA, NDC 52735-508-29; Food
Lion brand, Food Lion LLC, Salisbury, NC,
NDC 55316-396-40; Good Neighbor Pharmacy,
AmerisourceBergen, Valley Forge, PA, NDC 24385-396-40;
Hannaford brand, Hannaford Bros. Co., Scarborough, ME,
NDC 41268-396-40; Health Pride brand, The Great Atlantic
& Pacific Tea Co., Montvale, NJ; Healthy Generations
brand, Supervalu Inc., Eden Prairie, MN;
HyVee brand, Hy-Vee, Inc. West Des Moines, IA,
NDC 42507-396-40; Kroger brand, The Kroger Co.,
Cininnati, OH, NDC 30142-396-40; Leader brand,
Cardinal Health, Dublin, OH, NDC 37205-833-40;
Longs brand, Longs Drugs, Walnut Creek, CA,
NDC 12333-9249-1; Medic brand, Winn-Dixie Stores,
Inc., Jacksonville, FL, NDC 56039-396-40;
The Medicine Shoppe brand, Medicine Shoppe
International, Inc., St. Louis, MO,
NDC 49614-339-40; Meijer brand, Meijer Dist., Inc.,
Grand Rapids, MI, NDC 41250-396-35 and 41250-396-40;
Publix brand, Publix Super Markets, Inc., Lakeland, FL,
NDC 56062-396-40; Roundy’s brand, Roundy’s, Inc.,
Milwaukee, WI; ShopRite brand, Wakefern Food Corp,
Elizabeth, NJ; Sunmark brand, McKesson, San Francisco,
CA, NDC 49348-687-39 and 49348-687-44;
Swan brand, Cumberland Swan, Smyrna, TN,
NDC 0869-0396-40; Top Care brand, Topco Assoc LLC,
Skokie, IL, NDC 36800-396-40 and Western Family brand,
Western Family Foods, Inc., Portland, OR,
Recall # D-015-6;
b) GoodSense brand Milk of Magnesia (magnesium hydroxide),
400 mg, Oral Liquid, Mint Flavor, in 12 and 26 FL OZ
bottles, Distributed by Perrigo Co., Allegan, Michigan,
OTC. Product is distributed under the following brand
names: Best Yet brand, C&S Wholesale Grocers, Inc,
Brattleboro, VT; Brite-Life brand, Bergen Brunswig Drug
Company, Orange, CA, NDC 24385-332-40; CVS Pharmacy
brand, Woonsocket, RI; Eckerd brand, Eckerd Drug Co.,
Clearwater, FL, NDC 194586059-1; Equaline brand,
Albertsons, Inc., Boise, ID, NDC 41163-332-35 and
41163-332-40; Family Dollar, Family Dollar Services,
Inc., Charlotte, NC, NDC 55319-332-40;
Family Pharmacy brand, Family Pharmacy, Southeastern, PA,
NDC 52735-520-29; Giant Eagle brand, Giant Eagle, Inc.,
Pittsburgh, PA, NDC 56194-332-40; Good Neighbor Pharmacy,
AmerisourceBergen, Valley Forge, PA, NDC 24385-332-40;
Hannaford brand, Hannaford Bros. Co., Scarborough, ME,
NDC 41268-332-40; Health Pride brand, The Great Atlantic
& Pacific Tea Co., Montvale, NJ; Healthy Generations brand,
Supervalu Inc., Eden Prairie, MN, NDC 38045-332-40;
HyVee brand, Hy-Vee, Inc. West Des Moines, IA,
NDC 42507-332-40; Kroger brand, The Kroger Co.,
Cincinnati, OH, NDC 30142-332-40; Leader brand, Cardinal
Health, Dublin, OH, NDC 37205-834-40; Longs brand, Longs
Drugs, Walnut Creek, CA, NDC 12333-9248-1; The Medicine
Shoppe brand, Medicine Shoppe International, Inc.,
St. Louis, MO, NDC 49614-332-40; Meijer brand, Meijer
Dist., Inc., Grand Rapids, MI, NDC 41250-332-35 and
41250-332-40; Publix brand, Publix Super Markets, Inc.,
Lakeland, FL, NDC 56062-332-40; Roundy’s brand, Roundy’s,
Inc., Milwaukee, WI; Safeway brand, Safeway Inc.,
Pleasanton, CA; NDC 21130-332-40; ShopRite brand,
Wakefern Food Corp, Elizabeth, NJ; Sunmark brand, McKesson,
San Francisco, CA, NDC 49348-688-39 and 49348-688-44;
Swan brand, Cumberland Swan, Smyrna, TN, NDC 0869-0332-40;
Top Care brand, Topco Assoc LLC, Skokie, IL,
NDC 36800-332-40 and Western Family brand, Western Family
Foods, Inc., Portland, OR. Recall # D-016-6;
c) GoodSense brand Milk of Magnesia (magnesium hydroxide),
400 mg, Oral Liquid, Cherry Flavor, in 12 and 26 ounce
bottles Distributed by Perrigo Co., Allegan, Michigan,
NDC 0113-0949-40 ---- Product is distributed under the
following brand names: CVS Pharmacy brand, Woonsocket,
RI; Eckerd brand, Eckerd Drug Co., Clearwater, FL,
NDC 19458-9450-1 and 19458-9450-2; Equate brand,
Wal-Mart Stores, Inc, Bentonville, AR,
NDC 49035-949-35; Good Neighbor Pharmacy,
AmerisourceBergen, Valley Forge, PA, NDC 24385-608-40;
Healthy Generations brand, Supervalu Inc., Eden Prairie,
MN, NDC 38045-949-40; HyVee brand, Hy-Vee, Inc. West
Des Moines, IA, NDC 42507-949-40; Leader brand,
Cardinal Health, Dublin, OH, NDC 37205-459-40; The
Medicine Shoppe brand, Medicine Shoppe International,
Inc., St. Louis, MO, NDC 49614-338-40; Meijer brand,
Meijer Dist., Inc., Grand Rapids, MI, NDC 41250-949-35
and 41250-949-40; Publix brand, Publix Super Markets,
Inc., Lakeland, FL, NDC 56062-949-40 and Sunmark brand,
McKesson, San Francisco, CA, NDC 49348-680-39,
Recall # D-017-6
CODE
a) 12 oz lots: 4LK0332, 4MD0179, 4MK0132, 4MK0286,
5AD0128, 5AD0182, 5AK0343, 5BK0081, 5CK0034, 5CK0035,
5CK0036, 5CK0236, 5CK0298, 5CK0299, 5CK0389, 5DK0077,
5DK0127, 5DK0231, 5DK0282, 5EK0377, 5FK0267, 5FK0280,
5FK0281, 5FK0393, 5GK0296, 5HK0024, 5HK0039, 5HK0107
and 5HK0375. 26 oz lots: 4MK0131, 4MK0288, 5AD0121,
5AD0126, 5AD0131, 5AK0068, 5AK0156, 5AK0348, 5BD0084,
5BK0019, 5BK0085, 5BK0322, 5BK0323, 5BK0425, 5CD0155,
5CK0073, 5CK0291, 5CK0393, 5DK0087, 5DK0116, 5ED0154,
5ED0218, 5FK0122 and 5GK0084;
b) 12 oz lots: 4LK0328, 4LK0342, 4MK0127, 4MK0128,
4MK0161, 4MK0287, 5AK0136, 5AK0137, 5AK0212, 5AK0344,
5BK0010, 5BK0011, 5BK0082, 5BK0353, 5CK0039, 5CK0078,
5CK0237, 5CK0238, 5CK0302, 5CK0390, 5DK0082, 5DK0132,
5DK0238, 5DK0239, 5ED0156R, 5EK0053, 5EK0054, 5EK0111,
5EK0335, 5EK0336, 5FK0139, 5FK0293, 5FK0346, 5GK0049,
5GK0050, 5GK0332, 5HK0034, 5HK0100 and 5HK0187.
26 oz lots: 4MK0289, 5AD0120, 5AK0110, 5AK0157, 5BK0015,
5BK0016, 5BK0017, 5BK0088, 5BK0328, 5CK0292, 5CK0394,
5DK0088, 5DK0138, 5DK0308, 5EK0119, 5EK0196, 5EK0366,
5GK0081, 5GK0082, 5GK0083, 5GK0335, 5HK0111, 5HK0195
and 5HK0292;
c) 12 oz lots: 4MD0180, 5AD0123, 5AD0213, 5BK0012, 5BK0084,
5BK0354, 5CK0074, 5CK0300, 5DK0081, 5DK0131, 5EK0365,
5FK0137, 5FK0198, 5FK0288, 5FK0290, 5FK0389, 5GK0060,
5GK0120, 5GK0297, 5HK0190 and 5HK0391.
26 oz lots: 5AD0122, 5CK0135, 5DK0140, 5DK0141, 5DK0244,
5DK0309, 5ED0120, 5EK0197, 5EK0367, 5EK0368, 5FK0135,
5FK0136, 5FK0195, 5GK0087, 5GK0336 and 5HK0110
RECALLING FIRM/MANUFACTURER
Perrigo Company, Allegan, MI, by letters dated October 7, 2005 on or about October 10, 2005. Firm initiated recall is ongoing.
REASON
Defective Container; tamper evident seal may be split.
VOLUME OF PRODUCT IN COMMERCE
2,114,688 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0033-6;
b) Platelets Pheresis, Leukocytes Reduced,
Recall # B-0034-6
CODE
a) Unit number: 6941703;
b) Unit number: 6943924
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 6, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0041-6;
b) Cryoprecipitated AHF, Recall # B-0042-6;
c) Recovered Plasma, Recall # B-0043-6
CODE
a), b), and c) Unit number: 2042083
RECALLING FIRM/MANUFACTURER
Florida Blood Centers, Inc., Orlando, FL, by telephone on March 19, 2004 or by facsimile on March 26, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL and Austria

_______________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-0053-6;
b) Recovered Plasma, Recall # B-0054-6
CODE
a) and b) Unit number: 2845379
RECALLING FIRM/MANUFACTURER
Florida Blood Centers, Inc., Orlando, FL, by telephone on April 8, 2004 or by facsimile on April 23, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL and Austria

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0055-6
CODE
Unit number: 71X07583-8 (Part 2)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL, by facsimile on December 9, 2004. Firm initiated recall is complete.
REASON
Platelets Pheresis, with an unacceptably low volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

_______________________________
PRODUCT
Source Plasma, Recall # B-0056-6
CODE
Unit Numbers: DF0043780, DF0043940, DF0044021, DF0044229, DF0044300, DF0044515, DF0044615, DF0044822
RECALLING FIRM/MANUFACTURER
DCI Biologicals Dunedin, LLC, Dunedin, FL, by e-mail on August 9, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for viral markers, but were not properly quarantined after the receipt of post donation information related to recent ear piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
England

_______________________________
PRODUCT
Whole Blood for further manufacturer of in-vitro diagnostics, Recall # B-0061-6
CODE
Unit number: TS22173
RECALLING FIRM/MANUFACTURER
Advanced BioServices, LLC, dba Trimar Hollywood, Inc., Reseda, CA, by facsimile on June 16, 2004. Firm initiated recall is complete.
REASON
Blood product, which tested repeatedly reactive for the antibody to hepatitis C virus (anti-HCV), but was labeled as testing negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Red Blood Cells, Recall # B-0062-6
CODE
Unit number: GC14328
RECALLING FIRM/MANUFACTURER
Southern California Permanente Medical Group Blood Donor Center, Downey, CA, by telephone on September 23, 2002. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that was designated as a low volume collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
Platelets, Recall # B-0074-6
CODE
Unit number: FL20041
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on May 29, 2005. Firm initiated recall is complete.
REASON
Platelets, corresponding to a unit of red cells that was possibly contaminated with Streptococcus Beta Hemolytic Group G, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0075-6
CODE
Unit number: 01W13872
RECALLING FIRM/MANUFACTURER
American National Red Cross, New York-Penn Region, West Henrietta, NY, by telephone on July 7, 2004, and by letter dated July 8, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that was possibly contaminated with multiple bacterial species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0097-6
CODE
Unit number: 6387988
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 22, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0098-6
CODE
Unit numbers: 6863756, 6863129 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 22, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0099-6;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-0100-6
CODE
a) Unit number: 6859823;
b) Unit number: 6862067
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 22, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0101-6;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-0102-6
CODE
a) Unit numbers: 6509411, 6504021;
b) Unit numbers: 6507181, 6501951
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 16, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0103-6
CODE
Unit number: 0744275
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 16, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0104-6;
b) Platelets Pheresis, Leukocytes Reduced,
Recall # B-0105-6
CODE
a) Unit number: 6859717;
b) Unit numbers: 6859717, 6858357
(Parts 1 and 2), 6856025 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 20, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CO

______________________________
PRODUCT
Source Plasma, Recall # B-0120-6
CODE
Unit numbers: 6270363957, 6270363544, 6270362964, 6270361298, 6270360725, 6270360133, 6270359182, 6270358443, 6270358007, 6270357262, 6270356673, 6270355991
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Salt Lake City, UT, by facsimile on February 6, 2004. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who had received a piercing within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
NC

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0125-6
CODE
Unit number: 10190-9399
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., dba United Blood Services, Scottsdale, AZ, by telephone on January 8, 2005. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0127-6
CODE
Unit number: 24749-4029 (Part 2)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., dba United Blood Services, Scottsdale, AZ, by telephone on December 28, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of red cells that was hemolyzed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0138-6;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-0139-6
CODE
a) Unit numbers: 6375156, 6375160, 6375162;
b) Unit numbers: 6375163, 6375143, 6375151,
6375152, 6375155, 6375158
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, on January 7, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose arm scrubs may have been incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0141-6
CODE
Unit number: 21384-1310
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fargo, ND, by letter dated February 21, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ND

______________________________
PRODUCT
Recovered Plasma, Recall # B-0145-6
CODE
Unit number: 6104967
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on August 19, 2002. Firm initiated recall is complete.
REASON
Blood product, which was untested for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

______________________________
PRODUCT
Red Blood Cells, Recall # B-0146-6
CODE
Unit number; 5200924
RECALLING FIRM/MANUFACTURER
Ogden Medical Center, Inc., Ogden, UT, on January 25, 2001. Firm initiated recall is complete.
REASON
Blood product, which tested positive for the hepatitis C virus (HCV), but was not labeled with a biohazard label, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
UT

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0147-6
CODE
Unit number: 6851683
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, on July 30, 2002. Firm initiated recall is complete.
REASON
Blood product, which was inappropriately distributed in a single storage bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Platelets Pheresis, Recall # B-0148-6
CODE
Unit numbers: 304740, 306352, 306356 (Parts A & B)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, on December 1, 1997. Firm initiated recall is complete.
REASON
Blood product, which tested negative for the cytomegalovirus (CVM) but were collected from a donor who previously tested positive for CMV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CO

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Source Plasma, Recall # B-0076-6
CODE
Unit number: F-02138-046
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by letter dated April 14, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0095-6
CODE
Unit numbers: 6527304, 6411412
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on January 20, 2003. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during shipment and may have been hemolyzed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0121-6
CODE
Unit number: 101876268
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., dba United Blood Services, Scottsdale, AZ, by telephone on March 10, 2005 and by letter dated April 6, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for Leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0142-6
CODE
Unit number: 322969
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, on March 1, 1998. Firm initiated recall is complete.
REASON
Blood product, which was not leukoreduced within the appropriate time period after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0143-6
CODE
Unit numbers: 320429, 323441, 324132
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, on February 18, 1998. Firm initiated recall is complete.
REASON
Blood products, which were not leukoreduced within the appropriate time period after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0144-6
CODE
Unit number: 320447
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by on February 23, 1998. Firm initiated recall is complete.
REASON
Blood product, which was not leukoreduced within the appropriate time period after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Boston Scientific brand Signal Acquisition Module (SAM), a Realtime Position Management (RPM) System, Catalog/Model Numbers: 8300, Recall # Z-0112-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific, San Jose, CA, by letters on April 1, 2005.
Manufacturer: Boston Scientific, Cedex, France. Firm initiated recall is ongoing.
REASON
The device has the potential for overheating its transformer and has the potential for fire hazard.
VOLUME OF PRODUCT IN COMMERCE
69 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) K 520411-2, Hercep Test, 35 Test, HER2, Protein,
Recall # Z-0113-06;
b) K 520711-2, Hercep Test, 35 Test, HER2, Protein,
Recall # Z-0114-06
CODE
a) Lot number: 00016943;
b) Lot numbers: 00016965, 100018107
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dakocytomation California, Inc., Carpinteria, CA, by letter dated September 29, 2005.
Manufacturer: Dakocytomation, Denmark. Firm initiated recall is ongoing.
REASON
Formulation error in the Visualization Reagent (vial 3) component contained in Hercep Test Kits. The error was in the concentration of Polyethylene Glycol contained in the formulation.
VOLUME OF PRODUCT IN COMMERCE
965 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Product names: a) Alginate Dental Impression Material Regular Set, Cinnamon
Flavor, Pink Color
b) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color
c) Alginate Dental Impression Material Regular Set, Mint Flavor, Pink Color
Dustless
d) Alginate Dental Impression Material Regular Set, Cherry Flavor, No color
e) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color
f) Alginate Dental Impression Material Fast Set, Mint Flavor, Pink Color,
Dustless
g) Alginate Dental Impression Material Fast Set, Cherry Flavor, No color.
All are varieties of alginate dental impression powder packaged in aluminum foil pouches labeled as containing approximately 454 grams (one pound), or in the case of one foreign account, packaged in unlabeled 25 lb. and 39 lb. bulk containers. The alginate impression material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient’s teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. This product was cleared as a prescription device; however, it is not labeled as such. Recall # Z-0128-06
CODE
Lot Numbers 1232 1238 1243 1246 1257 1260 1261 1262 1263 1264 1269 1270 1272 1273 1274 1276 1277 1278 1289 1290 1291 1294 1295 1296 1298 1308 1309 1320 1231 1322 1324 1325 1329 1330 1331 1332 1343 1347 1348 1349 1352 1356 1363 1366 1367 1368 1372 1373 1374 1375 1380 1390 1391 1395 1396 1397 1399 1400 1403 1404 1406 1411 1414 1417 1418 1419 1421 1422 1426 1428 1431 1435 1439 1440 1442 1446 1447 1456 1457 1460 1461 1462 1468 1469 1470 1473 1480 1486 1488 1492 1493 1494 1500 1503 1504 1505 1511 1512 1516 1517 1518 1519
RECALLING FIRM/MANUFACTURER
Rite-Dent Manufacturing Corp., Hialeah, FL, by letters during the week September 26, 2005. Firm initiated recall is ongoing.
REASON
At least two of the ingredients used in the production of these products were not intended for human use. The ingredients are not listed in the master formula for these products nor are they listed on the ingredients list.
VOLUME OF PRODUCT IN COMMERCE
74,460 lbs
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
BirthNet OB Data Management System 91861, Recall # Z-0115-06
CODE
All serial numbers involved.
RECALLING FIRM/MANUFACTURER
Spacelabs Medical Incorporated, Issaquah, WA, by letters on October 13, 2004. Firm initiated recall is ongoing.
REASON
Potential for incorrect weight to be displayed.
VOLUME OF PRODUCT IN COMMERCE
44 devices
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 Individually packaged Obturators. Sterile EO. Single use, Recall # Z-0125-06
CODE
Lot 1164732
RECALLING FIRM/MANUFACTURER
St. Jude medical, DAIG Division, Inc., Minnetonka, MN, by letter dated September 20, 2005. Firm initiated recall is ongoing.
REASON
A lot of product contains a 6F Obturator with a hub that is incorrectly marked as 5 instead of the appropriate 6. The Obturator is correctly sized (6F) per the labeling on both the sterile bag and shelf carton.
VOLUME OF PRODUCT IN COMMERCE
340 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
TC-Plus Solution Femoral Component, model 21028, Femoral component, right, size 8, Recall # Z-0126-06
CODE
Exp. Date of 2011. Lot number 0411.13.6556. No serial number.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plus Orthopedics USA, San Diego, CA. by letter on July 23, 2005.
Manufacturer: Plus Endoprothetik AG, Rotkreuz, Switzerland. Firm initiated recall is complete.
REASON
Labeling discrepancy.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

_______________________________
PRODUCT
AMPLATZER Vascular Plug, Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages. Store in a cool, dry place. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. A stainless steel micro screw is welded to one of the platinum marker bands, which allows attachment to the 135 cm long deliver cable. The AMPLATZER Vascular Plugs are made in various sizes ranging from 4 to 16 mm in 2 millimeter increments, Recall # Z-0127-06
CODE
Lot numbers: M05F10-11, M05F15-12 and M05F02-47.
RECALLING FIRM/MANUFACTURER
AGA Medical Corporation, Golden Valley, MN, by letters dated September 1, 2005. Firm initiated recall is ongoing.
REASON
Five lots of AMPLATZER Vascular Plugs were sterilized in a load that was not validated for the AMPLATZER Vascular Plug. However, only three of those five lots were distributed.
VOLUME OF PRODUCT IN COMMERCE
81 units
DISTRIBUTION
Internationally

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINES - CLASS II

_______________________________
PRODUCT
a) Bulk medicated broiler starter poultry feed,
Recall # V-003-6;
b) Bulk medicated broiler finisher poultry feed,
Recall # V-004-6
CODE
a) SC7717;
b) FN7617
RECALLING FIRM/MANUFACTURER
Golden Rod Feed Mill, Inc., Cullman, AL, by telephone and visit on August 22, 2005. Firm initiated recall is complete.
REASON
Out of specification drug level for 3-Nitro-20 in medicated poultry feed.
VOLUME OF PRODUCT IN COMMERCE
54 tons
DISTRIBUTION
AL

_______________________________
PRODUCT
Metacam (meloxicam) 1.5 mg/mL Oral Suspension, Non-steroidal anti-inflammatory drug for oral use in dogs only, packaged in 10-ml bottles, RX, NADA #141-213, NDC 00010-6015-1, Recall # V-005-6.
CODE
Domestically distributed lots: 103ZM63, 103ZM63-3, 103ZM64-1, 113ZM71, 014ZM18-3, 034ZM40-4, 034ZM41-7, 044ZM64, 044ZM65, 064ZM83-5, 084ZM06, 094ZM24, 094ZM24-2, 094ZM25, 124ZM79, 015ZM17-8, 025ZM21, 035ZM23-8, 035ZM23-9. Foreign distributed lots: Canada - 014ZM18-5, 035ZM23, 044ZM64-1, 044ZM65-1, 044ZM66, 064ZM83-7, 064ZM84, 064ZM84-6, 084ZM07-1, 094ZM25-1, 103ZM64-5, 104ZM44-4, 123ZM80A-3, 123ZM80A-5, 123ZM94-10, 124ZM79-6. Germany - 014ZM17-2, 014ZM18, 015ZM17, 034ZM40-3, 034ZM41, 044ZM65-5, 053ZM95-1, 053ZM96-1, 064ZM83-4, 073ZM16-2, 084ZM06-2, 093ZM46-5, 103ZM64-2, 114ZM45-3. The Netherlands - 014ZM18-1, 034ZM41-1, 044ZM65-4, 053ZM96-6, 064ZM83-2, 064ZM85-2, 084ZM07-6, 093ZM46-7, 103ZM64-4, 114ZM45-2, 123ZM94-7, 124ZM79-8. Sweden/Finland - 035ZM23-4, 044ZM66-6, 053ZM95-4, 053ZM96-3, 053ZM96-7, 064ZM83-1, 084ZM07-5, 113ZM71-1, 114ZM45-4, 123ZM94, 123ZM94-3. Australia - 015ZM17-3, 034ZM41-5, 035ZM23-1, 044ZM66-10, 044ZM66-3, 064ZM84-2, 064ZM85-6, 084ZM07-4, 084ZM07-8, 094ZM25-4, 123ZM80A-2. Austria - 015ZM17-6, 034ZM41-2, 064ZM83-3, 084ZM07-02, 093ZM46-8, 123ZM94-8, 124ZM79-4. Belgium - 014ZM18-4, 015ZM17-7, 044ZM65-6, 044ZM66-1, 053ZM95-2, 064ZM83, 064ZM85-1, 093ZM46-1, 103ZM63-1, 104ZM44-2. United Kingdom - 014ZM17, 014ZM18-6, 015ZM17-2, 034ZM40, 044ZM65-3, 044ZM66-4, 044ZM66-8, 053ZM95, 063ZM11, 064ZM84-7, 064ZM85-4, 073ZM16, 073ZM16-1, 084ZM07, 093ZM35-1, 093ZM46, 093ZM46-4, 093ZM46-9, 094ZM24-1, 103ZM63-2, 103ZM64, 104ZM44, 114ZM45-5, 123ZM94-2. Czech Republic/Slovakia/Slovenia - 124ZM79-2. Italy - 015ZM17-4, 034ZM41-3, 053ZM96-4, 064ZM84-5, 064ZM85, 093ZM46-6, 104ZM44-3, 123ZM94-5. Korea - 063ZM11-1, 092ZM90A-2, 122ZM17A-1. Poland - 124ZM79-3. Mexico - 014ZM18-2, 035ZM23-2, 043ZM49-10, 043ZM49-3, 053ZM94, 053ZM94-11, 102ZM98A-4, 104ZM44-5. New Zealand - 015ZM17-5, 044ZM65-2, 064ZM84-3, 084ZM07-7. Greece - 034ZM41-4, 084ZM06-1, 093ZM46-3, 094ZM25-2, 124ZM79-5. Spain - 014ZM17-1, 015ZM17-1, 044ZM66-2, 053ZM96-2, 064ZM84-1, 084ZM07-3, 093ZM46-2, 123ZM94-6, 124ZM79-1. Hungary - 124ZM79-7. Switzerland - 034ZM40-2, 043ZM49-6, 053ZM94-9, 064ZM84-4, 102ZM98A-2, 114ZM45-1, 123ZM80A-1. France - 034ZM41-6, 044ZM66-9, 053ZM95-3, 053ZM96-8, 063ZM11-2, 064ZM83-6, 064ZM84-8, 064ZM85-3, 084ZM07-9, 093ZM35, 103ZM64-3, 104ZM44-6, 114ZM45. Denmark/Norway/Iceland - 123ZM94-1, 123ZM94-4. Japan - 033ZM32, 104ZM44-1, 112ZM07A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boehringer Ingelheim Vetmedica, Inc., St. Joseph, MO, by letters dated September 1, September 2, and September 9, 2005 and by e-mail on September 5, and September 6, 2005.
Manufacturer: Boehringer Ingelheim Vetmedica, Inc., Elwood, KS. Firm initiated recall is ongoing.
REASON
Some of the units could be above or below specifications.
VOLUME OF PRODUCT IN COMMERCE
2,287,326 bottles (631,560 bottles in the U.S., 1,655,766 foreign)
DISTRIBUTION
IA, GA, and TN, and Internationally

______________________________
PRODUCT
a) Bulk nonmedicated custom swine and poultry feeds,
Recall # V-006-6;
b) Bulk medicated swine and poultry feeds, Recall # V-007-6
CODE
N/A
RECALLING FIRM/MANUFACTURER
Gold Eagle Cooperative, Goldfield, IA, by telephone or visit beginning August 30, 2005. Firm initiated recall is complete.
REASON
Swine and poultry feeds which may contain prohibited material are not labeled with the warning statement not to feed to cattle or other ruminants.
VOLUME OF PRODUCT IN COMMERCE
Approx. 15,323.68 tons of nonmedicated and medicated feed
DISTRIBUTION
IA, GA, MD, and MN

______________________________
PRODUCT
a) ADM Alliance Nutrition Metabalance 25/45 10485CPN
Medicated, A Complete Feed for Starting Pigs, containing
100 g/ton oxytetracycline and 140 g/ton neomycin base
(provided by neomycin sulfate 200 g/ton), packaged in
50-lb. bags, Recall # V-008-6;
b) Bulk ADM Alliance Nutrition Momentum 10-15 CTC/DEN
Medicated, A Complete Feed for Starting Pigs, containing
chlortetracycline 400 g/ton (200 mg/lb), and tiamulin
hydrogen fumarate 35 g/ton (17.5 mg/lb), product
#12005AYW, Recall # V-009-6;
c) Bulk ADM Alliance Nutrition Momentum 15-25 CTC/DEN
Medicated, A Complete Feed for Starting Pigs, containing
chlortetracycline 400 g/ton (200 mg/lb) and tiamulin
hydrogen fumarate 35 g/ton (17.5 mg/lb), product #11749AYW.
Recall # V-010-6
CODE
a) Lot # NH1525 and Lot # NH1885;
b) Lot # NH2385;
c) Lot # NH1735, Lot # NH2005, Lot # NH2275, and Lot # NH2315
RECALLING FIRM/MANUFACTURER
Recalling Firm: ADM Alliance Nutrition, Inc., Quincy, IL, by telephone on September 7, 2005.
Manufacturer: ADM Alliance Nutrition, Inc., New Hampton, IA. Firm initiated recall is complete.
REASON
The Type A medicated article used to manufacture the feed had expired.
VOLUME OF PRODUCT IN COMMERCE
153/50-lb. bags and 22,990 lbs. of bulk feed
DISTRIBUTION
IA

END OF ENFORCEMENT REPORT FOR NOVEMBER 9, 2005

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