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CODE
Freshness (sell by) dates
02JUN98 09JUN98 16JUN98 23JUN98 30JUN98 07JUL98 14JUL98 21JUL98 28JUL98 04AUG98 11AUG98.
MANUFACTURER
Frito-Lay, Inc., Pulaski, Tennessee; Frito-Lay, Inc., Beaverton,
Oregon.
RECALLED BY
Frito-Lay, Inc., Plano, Texas, by E-mail sent on May 4, 1998,
followed by visit. The firm issued a press release on May 6,
1998, and notified the Food Allergy Network. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
8,967,132 packages were distributed.
REASON
Product contains undeclared whole eggs.
PRODUCT
Mozzarella Cheese, 8 ounce pieces, in 3 pound plastic tubs.
Recall #F-543-8.
CODE
4/12/98.
MANUFACTURER
Tutto Latte Mozzarella Cheese Factory, Baldwin Park, California.
RECALLED BY
Manufacturer, by telephone on March 27, 1998, followed by visit.
California Department of Food and Agriculture issued a press
release on March 31, 1998. Completed recall resulted from sample
analysis collected by the California Department of Food and
Agriculture.
DISTRIBUTION
California, Nevada, Colorado.
QUANTITY
Firm estimated that little if any product remained on market at
time of recall initiation.
REASON
Product was contaminated with Listeria monocytogenes.
UPDATE
Recall #F-505-8, Treasure Cave brand Blue Cheese, in 4 ounce
squares, which appeared in the June 17, 1998, Enforcement Report
should read: CODE: 7 27 98 1;
QUANTITY
4,122
pounds were distributed.
CODE
Lots 99242 through 00142 followed by 4 digits which indicate the
time labeled - All codes manufactured between August 30, 1997,
and May 22, 1998.
MANUFACTURER
Riba Foods, Inc., Houston, Texas.
RECALLED BY
Manufacturer, by letter dated June 2, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION
Oklahoma and Texas.
QUANTITY
115.75 cases (147 jars) were distributed.
REASON
Product contains undeclared FD&C Yellow No. 5.
PRODUCT
Live Pacific Oysters, extra small cocktail size, sold in
1-bushel/10 dozen (120) oysters per bag. Recall #F-542-8.
CODE
Harvest Harvest location: date: 430-11 APR 29 1998 430-11 APR 30 1998 430-15 APR 30 1998 430-11 MAY 01 1998 430-12 MAY 05 1998 430-11 MAY 06 1998 430-12 MAY 06 1998 430-11 MAY 07 1998 430-15 MAY 07 1998 430-11 MAY 09 1998 430-15 MAY 09 1998 430-11 MAY 11 1998.
MANUFACTURER
Hog Island Shellfish Farms (doing business as Point Reyes Oyster
Co.), Marshall, California.
RECALLED BY
Manufacturer, by telephone beginning on May 15, 1998, and by
radio and televised press releases reported on May 16 and 17,
1998. Completed recall resulted from sample analysis and
follow-up by The California Food and Drug Branch.
DISTRIBUTION
California, Washington state, Arizona, Thailand.
QUANTITY
Approximately 79,980 oysters (6,665 dozen, approximately 666
bushels) were distributed.
REASON
Product may be contaminated with Norwalk-like virus and has been
associated with an outbreak of gastrointestinal illness.
CODE
Lot #9962 EXP 9/98.
MANUFACTURER
Forest Pharmaceuticals, Inc., Cincinnati, Ohio.
RECALLED BY
Forest Pharmaceuticals, Inc., subsidiary of Forest Laboratories,
Inc., St. Louis, Missouri, by letter dated June 5, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
2,081 boxes (10 tablets x 10 strips) were distributed.
REASON
Subpotent at 18 month assay.
PRODUCT
Nitrostat Sublingual Tablets (Nitroglycerin), 0.4 mg, in bottles
of 25, Rx, indicated for the acute relief of an attack or
prophylaxis of angina pectoris due to coronary artery disease.
NDC #0071-0570-13. Recall #D-193-8.
CODE
Lot #016N6F EXP 10/98.
MANUFACTURER
Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY
Parke-Davis, Division of Warner Lambert Company, Morris Plains,
New Jersey, by letter on June 2, 1998. Firm-initiated recall
complete.
DISTRIBUTION
Nationwide.
QUANTITY
25,722 bottles were distributed.
REASON
Subpotent at 15 month stability.
PRODUCT
a) Atrovent Nasal Spray .03% (ipratropium bromide), 30 mL; b)
Atrovent Nasal Spray .06% (ipratropium bromide), 15 mL, indicated
for the symptomatic relief of rhinorrhea (runny nose( associated
with allergic and non-allergic perennial rhinitis in adults and
children age 12 years or older. NDC #0597-0081-30;
NDC #0597-0086-76. Recall #D-194/195-8.
CODE
AtroventR Nasal Spray0.03% AtroventR Nasal Spray 0.06% LOT # EXP. DATE LOT # EXP. DATE 816011A Jun-98 866009A Jun-98 816014A Nov-98 866010B Jul-98 816015A Nov-98 866012B Oct-98 816016A Nov-98 866013A Nov-98 816017A Nov-98 867004A Oct-99 816020A Dec-98 867006A Nov-99 816021A Dec-98 867007A Nov-99 817001A Mar-99 867008A Nov-99 817007A Oct-99 867009A Dec-99 817008A Oct-99 867010A Dec-99. 817009A Nov-99 817010A Nov-99 817012A Nov-99 817013C Nov-99 817014A Nov-99MANUFACTURER
RECALLED BY
Manufacturer, by fax and by letter on June 23, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
a) Approximately 865,000 units; b) Approximately 456,627 units
were distributed.
REASON
Some units found to contain 2,4,-Dichlorobenzoic acid (DCBA)
(impurity from fill tubing.
CODE
Lot numbers: a) 004C7A EXP 2/99 and 004C7B EXP 2/99;
b) 006A7B EXP 12/98, 010J7A EXP 8/99, 029B8A EXP 7/99, 006A7A EXP
12/98, 029B8B EXP 7/99, 030B8C EXP 7/99; c) 030B8A EXP 7/99.
MANUFACTURER
Vintage Pharmaceuticals, Inc., Huntsville, Alabama.
RECALLED BY
Manufacturer, by letter May 20, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide and Puerto Rico.
QUANTITY
a) 158 128-ounce bottles and 1,488 16-ounce bottles;
b) 6,992 bottles(lot 006A7B) 15,608 bottles (Lot 010J7A), 13,780
(Lot 029B8A), 959 bottles (Lot 006A7A), 1,406 bottles (Lot
029B8B), 3,600 bottles (Lot 030B8C) were distributed.
REASON
Inability to support product shelf life through labeled
expiration date.
PRODUCT
Epinephrine Mist Inhalation Aerosol, USP, Bronchodilator, 15 mL
(1/2 ounce), for the temporary relief of shortness of breath,
lightness of chest and wheezing due to bronchial asthma, under
the following labels: Barre, Longs, Meijer, CVS.
NDC 0472-0970-99, NDC 12333-9284-1, NDC 41250-561-56,
NDC 50428-583-20. Recall #D-196-8.
CODE
Lot #RJ7627 EXP 11/99.
MANUFACTURER
Alpharma, Inc., Baltimore, Maryland.
RECALLED BY
Manufacturer, by letter dated June 18, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
53,600 units were distributed; firm estimates none remains on the
market.
REASON
Failure to meet USP leakage test criteria.
PRODUCT
Cool Mint Listerine Antiseptic (Thymol 0.064%), in 1 liter and
250 ml bottles. Recall #D-197-8.
CODE
Lot numbers: 02158L, 02258L, 02858L EXP 4/00.
MANUFACTURER
Warner Lambert, Lititz, Pennsylvania.
RECALLED BY
Manufacturer, by letter on June 9, 1998. Firm-initiated recall
complete.
DISTRIBUTION
Nationwide.
QUANTITY
Firm estimated that 1,965 cases remained on the market at time of
recall initiation.
REASON
One excipient did not meet specification (odor).
PRODUCT
Piroxicam Capsules, USP, Rx, for acute or long-term use in the
relief of signs and symptoms of osteoarthritis and rheumatoid
arthritis, packaged by Allscripts:
a) 10 mg capsules, packaged in bottles of 21 capsules,
NDC #54569-3974-0
b) 20 mg capsules, packaged in bottles of:
14 capsules, NDC #54569-3693-0; 10 capsules, NDC #54569-3693-1
7 capsules, NDC #54569-3693-2; 20 capsules, NDC #54569-3693-3
30 capsules, NDC #54569-3693-4; 15 capsules, NDC #54569-3693-5.
Recall #D-198/199-8.
CODE
Lot numbers: a) 6323030, 7027038, 7031020, 7035072, 7035102,
7052045, 7097123, 7142140, 7167030, 7174071, 7174093, 7176113,
7188107, 7260077, 7316095, 7323076, 7336137, 7342058
b) 6326092, 7318074, 6317095, 7062139, 6338149, 7316165, 7324091,
6323095, 6311129, 6331073.
MANUFACTURER
Novopharm Ltd., Scarborough, Ontario, Canada (responsible firm).
RECALLED BY
Allscripts, Inc., Libertyville, Illinois, by letter dated June 8,
1998. Firm-initiated recall ongoing.
DISTRIBUTION
California, Ohio, Washington, New Hampshire, Kansas, Florida,
Louisiana, New Mexico, Mississippi, Georgia, Tennessee, Iowa,
Idaho, Missouri, Michigan, Indiana, Illinois and South Dakota.
QUANTITY
552 bottles of 21 - 10 mg capsules, and 283 bottles of 14, 166
bottles of 10, 306 bottles of 7, 55 bottles of 20, 99 bottles of
30 and 84 bottles of 15 - 20 mg. capsules were distributed. The
firm estimates that less than 25% of the product remains on the
market.
REASON
Lack of blend uniformity assurance.
CODE
Unit #29FP45774 (split unit P1/P2).
MANUFACTURER
American Red Cross Blood Services, Norfolk, Virginia.
RECALLED BY
Manufacturer, by letter dated March 30, 1998, and April 30, 1998.
Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
1 split unit was distributed.
REASON
Blood product was collected in a manner that compromises the
sterility of the product.
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1298/1299-8.
CODE
Unit #29GP47756.
MANUFACTURER
American Red Cross Blood Services, Norfolk, Virginia.
RECALLED BY
Manufacturer, by letter dated March 26, 1998, and "Questionable
Plasma Inquiry" on March 26, 1998. Firm-initiated recall
complete.
DISTRIBUTION
North Carolina and California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from an unsuitable donor.
PRODUCT
Red Blood Cells. Recall #B-1302-8.
CODE
Unit #29FE95620.
MANUFACTURER
American Red Cross Blood Services, Norfolk, Virginia.
RECALLED BY
Manufacturer, by letter dated April 14, 1998. Firm-initiated
recall complete.
DISTRIBUTION
North Carolina.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported living in
an area designated as endemic for malaria.
PRODUCT
Red Blood Cells. Recall #B-1304-8.
CODE
Unit #1465758.
MANUFACTURER
1
Central Kentucky Blood Center (CKBC), Lexington, Kentucky.
RECALLED BY
Manufacturer, by letter dated May 16, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Kentucky.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had traveled to an
area designated as endemic for malaria.
PRODUCT
Red Blood Cells. Recall #B-1305-8.
CODE
Unit #1465759.
MANUFACTURER
Central Kentucky Blood Center (CKBC), Lexington, Kentucky.
RECALLED BY
Manufacturer, by letter on May 16, 1998. Firm-initiated recall
complete.
DISTRIBUTION
Kentucky.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had traveled to an
area designated as endemic for malaria.
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-1306/1307-8.
CODE
Unit #1454033.
MANUFACTURER
Central Kentucky, Blood Center, Lexington, Kentucky.
RECALLED BY
Manufacturer, by letter dated June 3, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Kentucky.
QUANTITY
1 unit of each component was 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) Cryoprecipitate; c) Recovered Plasma.
Recall #B-1308/1310-8.
CODE
Unit #1394697.
MANUFACTURER
Central Kentucky Blood Center (CKBC), Lexington, Kentucky.
RECALLED BY
Manufacturer, by letter dated June 3, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Kentucky, Missouri, Maryland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor living with a daughter
who tested positive for hepatitis C.
PRODUCT
a) Red Blood Cells b) Platelets; c) Recovered Plasma.
Recall #B-1311/1313-8.
CODE
Unit #1457861.
MANUFACTURER
Central Kentucky Blood Center (CKBC), Lexington, Kentucky.
RECALLED BY
Manufacturer, by letter dated June 8, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Kentucky and Maryland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor living with a
stepfather who had been diagnosed with hepatitis.
CODE
Unit #17183-4104.
MANUFACTURER
United Blood Services, San Angelo, Texas.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on
February 2, 1998. Firm-initiated recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a unit of whole blood with an
extended collection time.
PRODUCT
Whole Blood. Recall #B-1303-8.
CODE
Unit #GZ36659.
MANUFACTURER
Metropolitan Washington Blood Bank, Bethesda, Maryland.
RECALLED BY
Manufacturer, by telephone on or about January 29, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Virginia.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
PRODUCT
Plasma-Cryosupernatant. Recall #B-1315-8.
CODE
Unit #50LJ01862.
MANUFACTURER
American Red Cross Blood Services, Toledo, Ohio.
RECALLED BY
Manufacturer, by telephone on February 10, 1998, and by letter
dated March 5, 1998. Firm-initiated recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a unit of whole blood with an
extended collection time.
RECALLS AND FIELD CORRECTIONS: DEVICES
-- CLASS II
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:
a) Sterile Needle Counter, Individually Packaged, with Reorder
Nos. 1105, 1314, 1315, 1330, 1360, 1614, 1615, 1625, 1630,
1635-I, 1660;
b) Bulk, Non-sterile Needle Counters, with Reorder Nos. NS-1105,
NS-1314, NS-1315, NS-1330, NS-1360, NS-1614, NS-1615, NS-1625,
NS-1630, NS-1660;
c) Surgi-Start Kits containing Needle Counter, with Reorder Nos.
7519, 7539, 7766, 7815, 7866, K-1615-S, K-1615-S3, K-1615-Z,
K-1615-Z3, K-1630-S, K-1660-S, K-1615-S4, K-1614-6PBP,
K-1630-3BMM, K-1330-1DOC, K-1630-S3, K-1615-2FAP, K-1615-4SLH,
K-1615-2CAC, 7463-COG2, 7416-KCW, 7463-MDW, 7694-SGB3, 7430-BAB,
7463-BVB, 7615-UMD4, 7715-NRA5, 7653-NAS, 7614, 7614-T4,
7735-WII3, 7663-CCL2, 7815-ALA2, 7466-MCW2, 7436-NON, 7466-MCM2,
7514-POW2, 7466-INI2, 7663, 7514-SMR2, 7815-T8, 7415-KCW,
7616-CAC3, 7663-MIM2, 7463-SCN2, 7514-MAF, 7614-KCW,
7416-KCW, 7612-SAB, 7514-NMT, 7661-CAC2. Recall #Z-673/675-8.
CODE
Lot numbers:
71881 72051 72201 72353 72473 72591 71911 72061 72211 72371 72481 72603 71921 72091 72231 72373 72483 72611 71926 72101 72241 72381 72491 72621 71951 72111 72251 72383 72511 72651 71961 72121 72261 72401 72513 72661 71971 72131 72271 72403 72521 72671 71981 72141 72281 72411 72531 72721 71991 72161 72301 72451 72533 72731 72001 72171 72311 72453 72543 72801 72031 72181 72321 72463 72551 72811 72041 72191 72341 72471 72581 72821 72861 72881 72891 72901 72961 72971 73001.MANUFACTURER
RECALLED BY
Graphic Controls Corporation, Buffalo, New York, by letter dated
June 12, 1998. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide, Canada, France, Spain.
QUANTITY
361,864 needle counters were distributed.
REASON
The foam insert (strip) has the potential to detach from the
plastic needle box.
PRODUCT
GFX Over-The-Wire Coronary Stent System, indicated for use in
patients eligible for balloon angioplasty with symptomatic
ischemic disease due to discrete de novo lesions in coronary
arteries (length 30 mm) with a reference vessel diameter of 3.0
mm to 4.0 mm. Stenting is intended to improve coronary luminal
diameter: a) Catalog No. DGFW3512; b) Catalog No. DGFW3518.
Recall #Z-676/677-8.
CODE
Lot numbers: a) 8E21E19; b) 8E14E11.
MANUFACTURER
Arterial Vascular Engineering, Inc., (AVE), Santa Rosa,
California.
RECALLED BY
Manufacturer, by telephone on May 28, 1998, followed by letter.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
170 units were distributed.
REASON
The devices are subject to a slow inflation/deflation time of the
balloon segment of the coronary stent delivery system.
PRODUCT
APR-T Revision Hip Stems, components of the APR Hip System used
to replace a diseased or otherwise dysfunctional hip joint:
a) APR-T Revision Hip Stem, Left, Catalog No. 7328-01-011;
b) APR-T Revision Hip Stem, Right, Catalog No. 7328-02-011.
Recall #Z-679/680-8.
CODE
All lot numbers.
MANUFACTURER
Sulzer Orthopedics, Inc., Austin, Texas.
RECALLED BY
Manufacturer, by telephone on June 1, 1998, followed by letter.
Firm-initiated recall ongoing.
DISTRIBUTION
Arizona, California, Florida, Louisiana, Michigan, New Mexico,
Nevada, South Carolina, South Dakota, Tennessee, Texas, Utah,
Australia.
QUANTITY
47 units were distributed.
REASON
The hip stem may be subject to fracture after being implanted.
PRODUCT
Osteonics Cement Plugs, one of several accessory products sold by
Osteonics used for cemented arthroplasty:
a) Osteonics Cement Plugs, Model No. B002-0125, Size 2;
b) Osteonics Cement Plugs, Model No. B006-0185 Size 6.
Recall #Z-681/682-8.
CODE
a) Serial No. XPC28; b) Serial No. XPC29.
MANUFACTURER
Osteonics Corporation, Allendale, New Jersey.
RECALLED BY
Manufacturer, by voice mail followed by letter on September 17,
1997. Firm-initiated recall complete.
DISTRIBUTION
Massachusetts, Michigan, Florida, New Mexico.
QUANTITY
a) 14 units; b) 3 units were distributed.
REASON
One lot labeled as Size 2 (12.5mm) plugs (Model No. B002-0125)
were actually Size 6 (18.5 mm) plugs (Model No. B006-0185), and
one lot labeled as Size 6 plugs were actually Size 2 plugs.
CODE
Lot numbers 698/97N97 and 1005/97N97.
MANUFACTURER
Allegiance Healthcare Corporation (formerly known as Bauer
Medical), Clearwater, Florida.
RECALLED BY
Manufacturer, by telephone beginning on November 4, 1997,
followed by visit and letter on March 6, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
250 units were distributed.
REASON
Introducer is too long (incorrect size), causing the biopsy
needle not to cut.
END OF ENFORCEMENT REPORT FOR JULY 22, 1998. BLANK PAGES MAY FOLLOW.