FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities.

September 16, 1998
98-37

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________
PRODUCT
Golden Happiness brand Sesame Rice Balls, net weight 230 grams/8.47 ounces, in clear rigid plastic trays, and 750 grams/26.45 ounces. Recall #F-591-8.

CODE
UPC CODEs: 7 76729 90361 7 is the CODE on the 750g size packages, and 7 76729 90362 4 is applied on the 230g size packages. Both CODEs were reported by the Canadian Food Safety and Inspection Service in a press release dated July 23, 1998.

MANUFACTURER
Golden Happiness Frozen Foods, Calgary, AB, Canada.

RECALLED BY
Sunnyvale Seafood Company, San Jose, California, by telephone and by press release on July 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
Oregon, Oklahoma, California.

QUANTITY
53 cases were distributed; firm estimates none remains on the market.

REASON
PRODUCT contains undeclared peanut butter.

________
PRODUCT
Fiesta brand and Mo Grande brand Chili Rellenos, packaged in bulk on one blue polyliner bag inside cardboard box. Recall #F-594-8.

CODE
The Mo Grande brand Chile Rellenos has Product Identification Number 60XFZ662, all production lot codes. The Fiesta brand Chile Rellenos has Product Identification Number 60XGK683, all production lot codes.

MANUFACTURER
S.A.N.A. International, S. De R.L. De C.V., Av. Migael De La Madrid, Sonora, Mexico.

RECALLED BY
J.R. Simplot Company/S.A.N.A. U.S.A., Boise, Idaho (distributor/importer), by fax beginning on July 31, 1998, and by letter on August 4, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas, Nevada, California, Arizona, New York, Colorado, Missouri, Indiana, Florida, Ohio, Idaho, Texas, Utah.

QUANTITY
571 boxes of the Mo Grande brand and 200 cases of the Fiesta brand were distributed.

REASON
Product may be contaminated with Salmonella.

________ UPDATES
Swallow brand Dried Sweet Potato, Recall #F-593-8, which appeared in the September 9, 1998 Enforcement Report should read: RECALLED BY: Wicsun Trading, Inc., Brooklyn, New York, by press release on April 24, 1998. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION: New York, Pennsylvania, Massachusetts.

Fernandina Seafood Company's Rock Shrimp Recall #F-595-8, which appeared in the September 9, 1998 Enforcement Report should read: Ongoing recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

The Aurora Foods Golden Raisins & Trail Mix Recall F-597/598-8, which appeared in the September 9, 1998 Enforcement Report should read: Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

________
PRODUCT
Extra Strength Acetaminophen Tablets, 500 mg, OTC, in 60 and 100 tablet bottles, under the Family Pharmacy and Fred's label. Recall #D-236-8.

CODE
Lot numbers: 8032215 and 8064485.

MANUFACTURER
Granutec, Inc., Wilson, North Carolina.

RECALLED BY
Manufacturer, by telephone on August 7, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
1,441 units of Fred's 60-count and 1,875 units of Family Pharmacy 100-count bottles were distributed.

REASON
Tablet mix-up - Aspirin and caffeine tablets were commingled with these lots during packaging.

________
PRODUCT
Alenic Alka Antacid, (Aluminum Hydroxide 95 mg/Magnesium Carbonate, Anhydrous 358 mg) Tablespoon, in 12 fluid ounce plastic bottles, OTC product used for the relief of heartburn, acid indigestion, sour stomach, and upset stomach. Recall #D-237-8.

CODE
Lot #70642.

MANUFACTURER
RIJ Pharmaceutical Company, Middelton, New York.

RECALLED BY
Rugby Laboratories, Inc., Norcross, Georgia (distributor), by letter on April 20, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
4,800 bottles were distributed.

REASON
Microbial contamination.

________
PRODUCT
Maxalt Tablets (Rizatriptan Benzoate), 10 mg, in complimentary (physician) sample cartons, Rx. Recall #D-238-8.

CODE
Lot #H0602 EXP 3/00.

MANUFACTURER
Merck Manufacturing Division, Division of Merck & Company, West Point, Pennsylvania.

RECALLED BY
Manufacturer, by letter on August 3, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
7,256 units were distributed.

REASON
Mislabeling - Some cartons contain individual foil packages which are printed with the incorrect product strength 5 mg while the tablets are actually 10 mg.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

________
PRODUCT
a) AK-SULF(R): (Sulfacetamide Sodium Ophthalmic Ointment), USP, 10% Sterile, 3.5 g tube, under the Akorn label, Rx sterile antibiotic ointment. NDC 17478-227-35. b) AK-SPORE(R) Ophthalmic Ointment(Neomycin and Polymyxin B Sulfates and Bacitracin Zinc), USP Sterile, 3.5 g tube, under the Akorn label, Rx sterile antibiotic ointment NDC 17478-235-35. Recall #D-228/229-8.

CODES
Lot # B80, EXP 05/03.

MANUFACTURER
Altana Inc., Melville, New York.

RECALLED BY
Manufacturer, by letter on July 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
8,040 units were distributed.

REASON
Mispackaging - Tubes of AK-Sulf were packaged into cartons labeled as AK-Spore.

________
PRODUCT
a) Loporessor(r) Ampoules (Metoprolol Tartrate, USP), 5 mg/5mL, in 5 mL ampules, Rx indicated as a selective beta-adrenoreceptor blocking agent for intravenous administration. NDC 0028-4201-33. b) Metoprolol Tartrate Ampoules, USP, 5 mg/5mL, in 5 ml ampuls, the generic version of Lopressor(r). NDC 0781-3070-75. Recall #D-234/235-8.

CODE
All lots.

MANUFACTURER
Novartis Pharma Ltd., Werk Stein, CH-4332 Stein, Switzerland.

RECALLED BY
Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, by fax on March 25, 1998. Firm-initiated recall complete.

DISTRIBUTION
Undetermined.

QUANTITY
a) 3,484 cartons; b) 5,867 cartons were distributed.

REASON
Loose or labels falling off product.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Cryoprecipitated AHF; e) Recovered Plasma. Recall #B-1412/1416-8.

CODE
Unit numbers: a) KK49935, KK48013, KK45947, KC52899; b) KZ47897, KK48013, KC52899; c) KZ47897; d) KK45947; e) KK49935, KK48013, KC52899.

MANUFACTURER
Virginia Blood Services, Richmond, Virginia.

RECALLED BY
Manufacturer, by letter dated May 28, 1998. Firm-initiated recall complete.

DISTRIBUTION
Maryland, Virginia, District of Columbia, California, Switzerland.

QUANTITY
a) 4 units; b) 3 units; c) 1 unit; d) 1 unit; e) 3 units were distributed.

REASON
Blood products, collected from a donor taking the drug, Carbamazepine.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-1463/1465-8.

CODE
Unit #12FN35309.

MANUFACTURER
American Red Cross Blood Services, Charlotte, North Carolina.

RECALLED BY
Manufacturer, by letter dated April 30, 1998, and by telephone on April 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
North Carolina.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor with a history of Idiopathic Thrombocytopenic Purpura.

________
PRODUCT
a) Red Blood Cells; b) Cryoprecipitated AHF. Recall #B-1466/1467-8.

CODE
Unit numbers: 03C06689.

MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.

RECALLED BY
Manufacturer, by telephone on May 22, 1998, and by letter on June 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
Florida.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who had ear piercing within 12 months of donation.

________
PRODUCT
Platelets. Recall #B-1476-8.

CODE
03GJ48833, 03GK39535, 03GK39536, 03GS31943, 03GS31944.

MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.

RECALLED BY
Manufacturer, by letter dated June 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
Georgia.

QUANTITY
5 units were distributed.

REASON
Blood products had unacceptable platelet counts.

________
PRODUCT
Recovered Plasma. Recall #B-1477-8.

CODE
Unit #W08386.

MANUFACTURER
Aurora Area Blood Bank, Aurora, Illinois.

RECALLED BY
Manufacturer, by telephone on July 3, 1998, and by letter dated July 6, 1998. Firm-initiated recall complete.

DISTRIBUTION
Switzerland.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who received an accidental needle stick.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Source Leukocytes, for lab research only. Recall #B-1479/1482-8.

CODE
Unit #3171127.

MANUFACTURER
Gulf Coast Regional Blood Center, Houston, Texas.

RECALLED BY
Manufacturer, by fax on April 21, 1998, and by telephone on July 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products tested negative for anti-HCV, but were collected from a donor who had previously tested repeat reactive for anti-HCV.

________
PRODUCT
Reactive Human Serum. Recall #B-1483-8.

CODE
Lot #97-0014L.

MANUFACTURER
Centers for Disease Control and Prevention (CDC), Atlanta, Georgia.

RECALLED BY
Manufacturer, by letter dated April 17, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
2 vials were distributed.

REASON
Blood products were used as a reactive control serum tested positive for Hepatitis C.

________
PRODUCT
Platelets, Pheresis. Recall #B-1485-8.

CODE
Unit #P13644.

MANUFACTURER
Carolina-Georgia Blood Center, Greenville, South Carolina.

RECALLED BY
Manufacturer, by telephone on August 5, 1997. Firm-initiated recall complete.

DISTRIBUTION
South Carolina.

QUANTITY
1 unit was distributed.

REASON
Blood product was stored at an unacceptable temperatures.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Cryoprecipitate; d) Cryo Poor Plasma; e) Recovered Plasma. Recall #B-1486/1490-8.

CODE
Unit numbers: a) KF22086, KF21543, KF21050, KF20558; b) KF22086, KF21543; c) KF22086, KF21543, KF21050; d) KF20558; e) KF22086, KF21543, KF21050.

MANUFACTURER
Virginia Blood Services, Richmond, Virginia.

RECALLED BY
Manufacturer, by letter dated July 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia and California.

QUANTITY
a) 4 units; b) 2 units; c) 3 units; d) 1 unit; e) 3 units were distributed.

REASON
Blood products were collected from a donor taking the drug Carbamazepine.

________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1491/1492-8.

CODE
Unit #4025346.

MANUFACTURER
Community Blood Center, Dayton, Ohio.

RECALLED BY
Manufacturer, by letter dated January 22 or 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
Indiana and California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor with a history of cancer.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Cryoprecipitated AHF. Recall #B-1493/1496-8.

CODE
Unit #6467478.

MANUFACTURER
New York Blood Services (Center West), New York, New York.

RECALLED BY
New York Blood Center, Inc., New York, New York, by letter on or about July 14,1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products tested non-reactive for the antibody to the Hepatitis B core antigen (anti-HBc), but were collected from a donor who was previously repeatedly reactive for anti-HBc on two separate donations.

________
PRODUCT
Platelets, Pooled. Recall #B-1497-8.

CODE
Unit #P63832 (containing platelets, Unit 4118754).

MANUFACTURE
Carter Blood Center, Fort Worth, Texas.

RECALLED BY
Manufacturer, by telephone on July 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed. REASON
Pooled blood product contained a unit of platelets corresponding to a red blood cell unit that was clotted.

________
PRODUCT
Red blood Cells. Recall #B-1498-8.

CODE
Unit #0165842.

MANUFACTURER
LifePulse, LLC, St. Louis, Missouri.

RECALLED BY
Manufacturer, by telephone on January 6, 1998. Firm-initiated recall complete

. DISTRIBUTION
Missouri.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who traveled to an area considered endemic for malaria.

________
PRODUCT
a) Red Blood Cells; b) Source Leukocytes. Recall #B-1501/1502-8.

CODE
Unit #3315855.

MANUFACTURER
Gulf Coast Regional Blood Center, Houston, Texas.

RECALLED BY
Manufacturer, by fax on March 16, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas and New Jersey.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who had been deferred for skin piercing.

________
PRODUCT
a) Red Blood Cells; b) Platelets, Pheresis. Recall #B-1516/1517-8.

CODE
Unit numbers: a) 38W09383; b) 38P47748, 38P49886, 38P50352

MANUFACTURER
American Red Cross Great Lakes Region, Fort Wayne, Indiana.

RECALLED BY
Manufacturer, by letter on May 6, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
a) 1 unit; b) 3 units were distributed.

REASON
Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1529/1530-8.

CODE
Unit #03GK21470.

MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.

RECALLED BY
Manufacturer, by letter dated September 25, 1996, or by telephone on September 19, 1996. Firm-initiated recall complete.

DISTRIBUTION
Georgia and California.

QUANTITY
1 unit was distributed.

REASON
Blood products were collected from a donor with a history of jaundice.

________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1532/1533-8.

CODE
Unit #03GL14406.

MANUFACTURER
American Red Cross, Atlanta, Georgia.

RECALLED BY
Manufacturer, by letter dated September 24, 1996, or by telephone on September 25, 1996. Firm-initiated recall complete.

DISTRIBUTION
Georgia and California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor with a history of taking the drug Proscar.

_______
PRODUCT
Platelets. Recall #B-1539-8.

CODE
Unit #03K07394.

MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.

RECALLED BY
Manufacturer, by telephone on April 17, 1998, and by letter dated April 30, 1998. Firm-initiated recall complete.

DISTRIBUTION
Florida.

QUANTITY
1 unit was distributed.

REASON
Blood product was mislabeled as CMV antibody negative.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________
PRODUCT
Red Blood Cells. Recall #B-1478-8.

CODE
Unit #R01246.

MANUFACTURER
Carolina-Georgia Blood Center, Greenville, South Carolina.

RECALLED BY
Manufacturer, by telephone on July 30, 1996. Firm-initiated recall complete.

DISTRIBUTION
South Carolina.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

________
PRODUCT
Red Blood Cells. Recall #B-1484-8.

CODE
Unit #3509252.

MANUFACTURER
Community Blood Center, Dayton, Ohio.

RECALLED BY
Manufacturer, by telephone on April 11, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit was distributed.

REASON
Blood product was stored at unacceptable temperatures.

________
PRODUCT
Source Plasma. Recall #B-1504-8.

CODE
Unit 6457AW.

MANUFACTURER
SeraMed BioCenter, also known as Canton Plasma, Inc., Canton, Ohio.

RECALLED BY
Manufacturer, by letter dated October 17, 1997. Firm-initiated recall complete.

DISTRIBUTION
North Carolina.

QUANTITY
1 unit was distributed.

REASON
Blood product was not tested for syphilis.

________
PRODUCT
a) Platelets; b) Platelets, Pheresis. Recall #B-1514/1515-8.

CODE
Unit numbers: a) 18FQ33141, 18FQ33145, 18FQ33150, 18FQ33159, 18FQ33160, 18FQ33161, 18FQ33170, 18FQ33171, 18FQ33174, 18GF15956, 18S79701, 18S79710; b) 18P37460, 18P37465.

MANUFACTURER
American Red Cross, Lansing, Michigan.

RECALLED BY
Manufacturer, by telephone on May 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
Michigan.

QUANTITY
a) 12 units; b) 2 units were distributed.

REASON
Platelets not stored under continuous agitation.

________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-1527/1528-8.

CODE
Unit #04M69143.

MANUFACTURER
American Red cross Blood Services, Dedham, Massachusetts.

RECALLED BY
Manufacturer, by telephone on February 3, 1998. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts.

QUANTITY
1 unit of each component.

REASON
Blood products were not quarantined after the donor reported a post donation illness.

_______
PRODUCT
Platelets. Recall #B-1531-8.

CODE
Unit 03LM61412.

MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.

RECALLED BY
Manufacturer, by telephone on September 16, 1996. Firm-initiated recall complete.

DISTRIBUTION
Georgia.

QUANTITY
1 unit was distributed.

REASON
Blood product was prepared from a unit of whole blood designated as a difficult collection.

________
PRODUCT
Platelets. Recall #B-1537-8.

CODE
Unit #10585-7022.

MANUFACTURER
United Blood Services, Scottsdale, Arizona.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on May 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a unit of whole blood that had discrepant start and end times documented.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________
PRODUCT
a) INCSTAR N-tact PTH SP IRMA Kit for the in vitro quantitative determination of biologically active intact human parathyroid hormone (hPTH 1-84) in serum or plasma by immunoradiometric assay (IRMA), Catalog numbers 26100 and 26100J. B) INCSTAR N-tact PTH SP Beads, component number 26053. This is a component in the kits identified above, and is also sold separately. The beads are polystyrene beads coated with affinity-purified goat antibody specific for the 39-84 sequence of PTH. The recalled product is the component sold separately. products are used for in vitro testing to determine the level of human parathyroid hormone. Recall #Z-731/732-8.

CODE

a) Catalog number 26100, lots:  183568, 183568A, 183568B, 183568C
203548, 203638, 203638A, 203638B, 203638C, 223758, 223758A,
223758B, 223758C, 243598, 243598A, 243598B, 243598C, 243598D.
263738.
b) Catalog number 26100J, lot 203648
Component number 26053, lot 813513.

MANUFACTURER
DiaSorin (formerly INCSTAR Corporation), Stillwater, Minnesota.

RECALLED BY
Manufacturer, by letter on July 30, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
a) 871 kits; b) 19 vials were distributed.

REASON
The kits and beads released between April and July, 1998 have the potential to give lower test values than the actual patient levels of parathyroid hormone.

________
PRODUCT
Series Ten Thousand Endodiode Laser System, used in ophthalmic surgery. Recall #Z-838-8.

CODE
Model numbers L-120-0001-501 and L-130-0001-501.

MANUFACTURER
Alcon Laboratories, Inc., Irvine, California.

RECALLED BY
Manufacturer. FDA approved the firm's corrective action September 8, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
California, Florida, Georgia, Kentucky, Maryland, Michigan, New York, Ohio, Oregon, Tennessee, international.

QUANTITY
129 units were distributed.

REASON
The system might inadvertently emit a full power beam while in the "Ready" mode regardless of footswitch position, 21 CFR 1003.2(b)(2).

________
PRODUCT
Various Sterile Custom Surgical Trays, containing the Devon Needle Counter, used to perform various surgical procedures. However the recalled component is used to secure suture needles and to aid the surgeon in maintaining an accurate count of the number of suture needles during a surgical procedure. Recall #Z-844-8.

CODE
239 different catalog numbers are involved.

MANUFACTURER
Graphic Controls Corporation, Chatsworth, California (defective component).

RECALLED BY
Maxxim Medical, doing business as Sterile Design, Clearwater, Florida (repacker), by letter on July 6, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
16,734 kits were distributed.

REASON
Kits contain a recalled (Z-673/675-8) component, the Devon Needle Counter.

________ UPDATES
Recall #Z-836/837-8, which appeared in the September 9, 1998 Enforcement Report should be replaced with the following: PRODUCT
Replacement Cartridges for V-Vac Hand-powered Suction Unit, a single use oropharyngeal suction unit for patients in pre-hospital environment: a) Starter Kit, Catalog Nos. 985000 and 985015; b) Replacement Cartridge, Catalog Nos. 985001 and 985080. Recall #Z-836/837-8.

CODE
All lots with manufacturing date codes from 050198 (5/1/98) through 072298 (7/22/98).

MANUFACTURER
Laerdal Medical Corporation, Wappingers, New York.

RECALLED BY
Manufacturer, by letter on August 4, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Canada, Australia, Norway, Costa Rica.

QUANTITY
13,300 cartridges.

REASON
The intake valve may be partially or totally occluded possibly causing the suction unit to malfunction.

Devon Needle Counters, used to assist the medical practitioner in
maintaining an accurate count of the number of suture needles
used during a surgical procedure, Recall #Z-673/675-8, which
appeared in the July 22, 1998 Enforcement Report should read:
CODE
:
The following PRODUCTS/REORDER #s/LOT #s/PART #s are listed
below: STERILE 
NEEDLE COUNTERS, INDIVIDUALLY PACKAGED
Reorder #      Lot #               Part #
1105           72451               31142212

1314           72301               31142170
               72261
               72591
               71971
1315           72241               31142188
               72401
               72591
               72551
               72651
               71951
1330           72251               31142303
               72191
               72451
               72511
               72591
               72121
1360           72271               31142204
               72521
               72591
               72651
               71951
               71911
1614           72251               31142295
               72191
               72181
               72401
               72471
               72521
1615           72041               31142329
               72241
               72481
               71951
1625           71961               31142444
               72401
               72621
1630           72271               31142451
               72191
               72511
               72451
               72131
               72031
               71981
STERILE NEEDLE COUNTERS, INDIVIDUALLY PACKAGED
Reorder #      Lot #          Part #
1635-1         72061          31313425

1660           72091          31142477
               72141
               72471
               72611
SURGI-START KIT CONTAINING AFFECTED NEEDLE COUNTERS
Reorder #      Lot #          Part #
7519           72321          31144507
               72121
               72463
               71926
7539           72661          31144457
7614           72721          31145520
               72543
7663           72241          31145538
7766           72403          31144978
7815           72403          31144879
               72603
               72311
               72811
7866           72201          31145173
               72403
7415-KCW       72383          31290854
7416-KCW       72161          31323747
               72811
7430-BAB       72211          31330643
7436-NON       72531          31149373
7463-BVB       72251          31149902
7463-COG2      72161          31150363
               72451
7463-MDW       72321          31150355
               72971
               72161
7463-SCN2      72513          31149910
7466-INI2      72201          31150173
               72731
7466-MCM2      72121          31149845
7466-MCW2      72543          31149993
               72821
7514-MAF       72811          31151437
SURGI-START KITS CONTAINING AFFECTED NEEDLE COUNTERS
REORDER #      LOT #          PART #
7514-NMT       72821          31151379
7514-POW2      72161          31151742
7514-SMR2      72301          31306981
7612-SAB       72961          31325023
7614-KCW       72811          31152617
7614-T4        72661          31144895
               72881
7615-UMD4      72311          31152914
               72341
               72111
               72861

7616-CAC3      72801          31317376
7653-NAS       72341          31154480
               72353
               72661
7661-CAC2      72881          31175097
7663-CCL2      72591          31154142
               72201
               72881
               72121
               72511
               72961
7663-MIM2      72821          31154696
               72451
7694-SGB3      72211          31329603
               72901
7715-NRA5      72451          31152575
               72311
               72671
               72731
7735-WII3      72603          31153466
               72383
               73001
               72861
SURGI-START KITS CONTAINING AFFECTED NEEDLE COUNTERS
REORDER #      LOT #          PART #
7815-ALA2      72533          31152252
               72201
               72971
               72121
7815-T8        72821          31145272
               72881
K-1330-1DOC    72261          31151213
K-1614-6PBP    72241          31150918
K-1615-2CAC    72511          31150595
               72891
K-1615-2FAP    71961          31151155
               72611
K-1615-4SLH    72383          31151114
               72473
K-1615-S       71971          31141610
               72091
               72453
               72533
K-1615-S3      72373          31141859
K-1615-S4      72901          31141503
K-1615-Z       72241          31141776
               72581
K-1615-Z3      72051          31141735
               72121
               72381
               72471
               72551
K-1630-3BMM    72191          31151171

K-1630-S       72191          31141602
               72061
K-1630-S3      72403          31141867
               72483
               71881
K-1660-S       72061          31141586
               72403
               72533
               72473
BULK, NON-STERILE NEEDLE COUNTERS
REORDER #      LOT #          PART #
NS-1105        72171          31155362
NS-1314        72281          31155644
               72231
               71961
               72491
NS-1315        72281          31155255
               71991
               72531
NS-1330        72171          31155354
               72191
NS-1360        72101          31155248
               71961
NS-1614        72371          31155743
               72311
               71911
               72181
               72061
               71961
NS-1615        71951          31155735
               72411
NS-1625        72371          31155768
               72411
NS-1630        72371          31155776
               72251
               71911
               72001
NS-1660        71921          31155792
               72001
               72581.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

________
UPDATE
Baxter Healthcare Corporation's recall of Colleague Volumetric Infusion Pumps, which appeared in the September 9, 1998, Enforcement Report should be replaced with the following:

PRODUCT
Baxter Colleague Single Channel Volumetric Infusion Pump, Model 2M8151, used for continuous or intermittent fluid delivery through clinically acceptable routes of administration. Recall #Z-798-8.

CODE
All pumps manufactured and shipped from the manufacturing facility prior to 11/26/97 with Slave software below version 1.04.

MANUFACTURER
Baxter Healthcare Corporation, PTE, Ltd., Singapore.

RECALLED BY
Baxter Healthcare Corporation, I.V. Systems Division, Round Lake, Illinois, by letter dated January 13, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
4,221 units were distributed.

REASON
The battery charge level indicator may understate the true battery capacity. Also, the pumps may experience a 6-20% under-delivery due to slippage of the lower shuttle jaw of the pump head mechanism.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS: CLASS I

________
PRODUCT
Poultry feeds, medicated and non-medicated, packaged in 25 and 50 pound bags:

1.  AVI Pels
2.  Breeder Pellets
3.  Broiler Crumbles - CB
4.  Chick Starter AM
5.  Egg Maker Crumbles
6.  Fat and Finish Pellets
7.  Game Bird Crumbles
8.  Grower-Cal AM
9.  Grower-Cal Mash
10. Grower-Cal Pellets
11. Grower-Cal Crumbles
12. Hen Pellets
13. Layer Mash
14. Layer Pellets
15. Layer Crumbles
16. Turkey Grower Pellets
17. Turkey Grower Pellets - HS
18. Turkey/Pheasant Starter Crumbles, Med.
Recall #V-031/048-8.

CODE

Richford, VT production: R2088
Arcade, NY production:  A2088
Bow, NH production:  208N8
Hagerstown, MD production: H2088

MANUFACTURER

Blue Seal Feeds, Inc.,  Hagerstown, Maryland
Blue Seal Feeds, Inc., Arcade, New York
Blue Seal Feeds, Inc., Richford, Vermont
Blue Seal Feeds, Inc., Bow, New Hampshire.

RECALLED BY
Blue Seal Feeds, Inc., Londonderry, New Hampshire, by letters dated August 4 and 14, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
New England and Middle Atlantic States and Canada.

QUANTITY
Approximately 14,000 tons were distributed.

REASON
Eighteen medicated and nonmedicated poultry and gamebird feeds lacked dietary salt in the formulation which caused stunted growth and/or mortality and decreased egg production of layers.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS: CLASS III

________
PRODUCT

Panacur (fenbendazole) granules 22.2%(for control and removal of roundworms, hookworms, whipworms, and tapeworms). Recall #V-049-8.

CODES
DW17A (exp date 01/2000), EB78A (exp date 07/2000) EB79A (exp date 07/2000).

MANUFACTURER
Global Pharmaceuticals, Inc., Ontario, Canada (contract manufacturer).

RECALLED BY
Hoechst Roussel Vet, Warren, New Jersey (responsible firm), by letter dated May 18, 1998, followed by visit. Firm-initiated field correction (relabeling) complete.

DISTRIBUTION
Nationwide.

QUANTITY

Lot # EB78A - 2325 cartons/60 2gm packets
Lot # DW17A - 4294 cartons/42 4gm packets
Lot # EB79A - 1224 cartons/42 4gm packets

REASON
Cartons were mislabeled. The duration for treatment under the "Directions" was stated as 2 days instead of 3 days.

END OF ENFORCEMENT REPORT FOR SEPTEMBER 16, 1998.

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