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.
ENFORCE
06/24/1992
RECALLS AND FIELD CORRECTIONS: June 24, 1992
FOODS -- CLASS II
92-26
PRODUCT Style Shampoo with Pro-Vitamin Complex, Body Building Formula
for Fine Hair, in 15 ounce bottles. Recall #F-338-2.
CODE B18.
MANUFACTURER DowBrands L.P., Fridley, Minnesota.
RECALLED BY Manufacturer, by telephone May 16, 1992, followed by letter May
18, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,455 cases (12 bottles per case) were distributed.
REASON Product is contaminated with Pseudomonas aeruginosa.
PRODUCT Mission Valley brand Sweet Pickle Relish, in 1 gallon jars.
Recall #F-339-2.
CODE Jar code 10 1491, 11 1391.
MANUFACTURER Valley's Pride Food Products, Inc., Stockton, California.
RECALLED BY Manufacturer, by visit beginning December 17, 1991.
Firm-initiated recall ongoing.
DISTRIBUTION California.
QUANTITY 666 cartons were distributed; FDA estimates none remains on the
market.
REASON Product is contaminated with wood slivers.
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PRODUCT Hotel Del Coronado Hair Conditioner, in 1.3 fluid ounce plastic
bottles. Recall #F-341-2.
CODE C1 stamped on shipping cases.
MANUFACTURER Midik Packaging Corporation, Elkhart, Indiana.
RECALLED BY Manufacturer, by telephone March 2, 1992 and by FAX April 26,
1992. Firm-initiated recall ongoing.
DISTRIBUTION California.
QUANTITY 8,476 bottles were distributed; firm estimates none remains on
the market.
REASON Product is contaminated with Pseudomonas aeruginosa.
PRODUCT Cheese Bread Sticks, in 5 ounce cellophane trays and wrapped in
plastic, under the following labels: Orowheat, Gai's, Ralphs,
The Bakery (Lucky's), Raley, Safeway, and Rainbo, Baker's
Choice, Old San Francisco. Recall #F-342-2.
CODE 11611CP, 11621CP through 29811CP, 29821CP (April 26 through
October 25, 1991).
MANUFACTURER California Pretzel Company, Visalia, California.
RECALLED BY Manufacturer, by letter November 8, 1991. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 10,500 to 12,500 cases.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT Thrifty Maid Mandarin Oranges, in 11 ounce cans.
Recall #F-340-2.
CODE All product which bears a top line code with "P" in it.
MANUFACTURER The Monterey Canning Company, San Mateo, California (importer).
RECALLED BY Winn Dixie Stores, Inc., Jacksonville, Florida, by letter
February 26, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Florida, Alabama, South Carolina, North Carolina, Georgia,
Kentucky, Louisiana, Texas.
QUANTITY Undetermined. However, 4,974 cans were retrieved as of 5/5/92.
REASON Product contained in swollen cans.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Adenocard (adenosine) 3 mg/ml, a Rx sterile cardiac solution,
in 2 ml single dose vials, 10 vials per shelf carton.
Recall #D-398-2.
CODE Lot #311319.
MANUFACTURER Lyphomed, Division of Fujisawa USA, Inc., Grand Island, New
York.
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RECALLED BY Fujisawa Pharmaceutical Company, Division of Fujisawa USA,
Inc., Deerfield, Illinois, by letter June 9, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 73,010 vials were distributed; firm estimates 11 percent
remains on the market.
REASON The vials have a low fill volume.
UPDATE Various injectable drug products, manufactured by Royce
Laboratories, Recall #D-365/371-2, which appeared in the June
10, 1992 Enforcement Report has been extended as follows:
Heparin Sodium Injection, 5,000 USP units has been extended to
include lot #320179 EXP 2/94 and Sodium Chloride Injection,
USP, 0.9% has been extended to include lot #320140 EXP 1/94.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Darvon brand Propoxyphene Hydrochloride, USP, packaged in
blister packages with 10 capsules to a strip and 10 strips per
carton (100 capsules per carton). Recall #D-396-2.
CODE Lot number 5CZ50M blister packs in cartons. Other similar lot
numbers in bottles are not under recall.
MANUFACTURER Eli Lilly Industries, Inc., Carolina, Puerto Rico.
RECALLED BY Eli Lilly and Company, Indianapolis, Indiana, by letter May 8,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,039 packages were distributed
REASON The cartons are correctly labeled. The blister strips are
incorrectly labeled as Propoxyphene Napsylate.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT Red Blood Cells. Recall #B-319-2.
CODE Unit #50M01376.
MANUFACTURER American Red Cross Blood Services, Toledo, Ohio.
RECALLED BY Manufacturer, by telephone August 20, 1991 followed by letter
August 23, 1991. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON A unit of autologous Red Blood Cells, which tested repeatedly
reactive for the antibody to hepatitis C virus encoded antigen
(anti-HCV), was distributed without the required biohazard
labeling.
RECALLS AND FIELD CORRECTION: BIOLOGICS -- CLASS III
PRODUCT Red Blood Cells. Recall #B-320-2.
CODE Unit numbers: NA00220, NA00242, NA00259, NA00282.
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MANUFACTURER Northampton-Accomack Memorial Hospital, Nassawadox, Virginia.
RECALLED BY Manufacturer, by telephone September 11, 1991. Firm-initiated
recall complete.
DISTRIBUTION Virginia.
QUANTITY 4 units.
REASON Red Blood Cells labeled with the incorrect expiration date were
distributed.
RECALLS AND FIELD CORRECTION: DEVICES -- CLASS I
PRODUCT Sodasorb PrePak Carbon Dioxide Absorption Units, in a one size
cartridge form. Recall #Z-711-2.
CODE Batch numbers: AA11-B720-13 through AA11-B720-25 (includes 5
batches) AA12-B720-3 through AA12-B720-31 (includes 13 batches)
AB01-B720-2 through AB01-B720-31 (includes 24 batches)
AB02-B720-3 through AB02-B720-27A (includes 18 batches)
AB03-B720-3A (includes 1 batch).
MANUFACTURER W.R. Grace & Company, Atlanta, Georgia.
RECALLED BY W.R. Grace & Company, Lexington, Massachusetts, by letter May
7, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY Approximately 184,000 units were distributed.
REASON There may be occlusions in the top and bottom holes of the
PrePak panels, which can cause unexpected high gas flow
resistance during inhalation anesthesia.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Infant Resuscitator Kits: (a) with two oxygen lines;
(b) with one oxygen line. Recall #Z-773/774-2.
CODE Product #14543318, lot numbers: 201157, 112206, 201327, 202423.
MANUFACTURER Gibeck-Dryden Corporation, Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone and by letter March 27, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Utah, Idaho.
QUANTITY 2,460 kits were distributed; firm estimated that 60 percent of
the product remained on market at time of recall on 3/27/92.
REASON Some kits were assembled with the wrong elbow component.
PRODUCT Bipolar Atrial J Permanent Pacer Leads:
(a) Model ZY 52 JBV; (b) Model ZY 52 PJBV;
(c) Intermedics 406-04. Recall #Z-775/777-2.
CODE All active fixation bipolar atrial J leads shipped prior to
December 11, 1991.
MANUFACTURER Oscor Medical Corporation, Palm Harbor, Florida.
RECALLED BY Manufacturer, by telephone December 11, 1991. Firm-initiated
recall complete.
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DISTRIBUTION Nationwide, Canada, Australia.
QUANTITY 602 leads were distributed. Firm estimates none remains on the
market.
REASON Pacer leads may short out.
PRODUCT Soft Contact Lenses, Daily Wear (DW) and/or Extended Wear (EW):
(a) Hydrocurve II - DW & EW;
(b) Hydrocurve II - DW (Toric);
(c) Hydrocurve II - EW (Toric);
(d) Softmate B - DW;
(e) Softmate I -DW & EW;
(f) Softmate II - DW & EW;
(g) Signature - DW (Toric);
(h) CSI - DW;
(i) CSI-T -EW;
(j) CTL Lite - DW & EW;
(k) CTL Aquamarine - DW & EW. Recall #Z-778/788-2.
CODE Lot numbers: (a) BBLHB, BBNMZ, YBIUF; (b) BAWKT, BAWRU, BAXCX,
BBNMC, BBNOA; (c) YAXHU, YAXHW, YAXXE, YAYBW, YBHWD; (d)
BBDTX;
(e) BBEWP; (f) YBDCP, YBFRH, YBMAQ, YBFXF; (g) BBIDW, BBIQL,
BBOIP; (h) CBCYD, CBDDY, CBDFD; (i) CBCRE; (j) PAIMW; (k)
PAKIQ, PANEL.
MANUFACTURER Sola/Barnes-Hind, Sunnyvale, California.
RECALLED BY Sola/Barnes-Hind, San Diego, California, by letter July 17,
1991. Firm-initiated recall complete.
DISTRIBUTION California, Florida, North Dakota, New York, Virginia, Georgia,
Hawaii, Indiana, Louisiana, New Mexico, New York, Connecticut,
Maine, Rhode Island, South Carolina, Washington state, North
Carolina, Mississippi, Maryland, Texas.
QUANTITY (a) 1,020; (b) 961; (c) 4,563; (d) 939; (e) 405; (f) 843; (g)
747; (h) 669; (i) 177; (j) 6 units; (k) 56 units were
distributed.
REASON Lenses are labeled with incorrect parameters for base curve
and/or diameter measurements.
PRODUCT Concord/Portex 23/28 Microcatheter Systems, for continuous
spinal anesthesia:
(a) Catalog #4985-23/28; (b) Catalog #4987-23/28;
(c) Catalog #4989-23/28; (d) Catalog #A1011-22.
Recall #Z-789/792-2.
CODE All lots.
MANUFACTURER Concord/Portex, Keene, New Hampshire.
RECALLED BY Manufacturer, by letter May 13, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada, England.
QUANTITY Undetermined.
REASON Adverse performance of the microcatheters.
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PRODUCT Nortech Microelectrode Electrohydraulic Lithotripter Probe -
1.9 FR, Tip - 1.2 FR, Shaft - 120 cm, a sterile Rx device for
use with Northgate Technologies SD-1 and SD-100, ACMI EL-115
and AEH-2 EHL generators for the breakup of kidney stones.
Recall #Z-793-2.
CODE Catalog #9-190-12, lot #985.
MANUFACTURER Northgate Technologies, Inc., Arlington Heights, Illinois.
RECALLED BY Manufacturer, by telephone, followed by letter May 7, 1992.
Firm-initiated recall complete.
DISTRIBUTION California, New York, Colorado.
QUANTITY 39 boxes were distributed; firm estimates none remains on the
market.
REASON Improper seals on the Tyvek pouch containing the device
compromises the sterility of the device.
PRODUCT Laser Diode Module, Model LDM-135, used generally as a light
source in engineering and experimental applications.
Recall #Z-794-2.
CODE Serial numbers: None.
MANUFACTURER Imatronic Limited, Berkshire, United Kingdom (Imatronic, Inc.,
Batavia, Illinois).
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
June 2, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 213 units were distributed.
REASON Noncompliance with the performance standards for laser products
in that it failed to incorporate an emission indicator and beam
attenuator.
PRODUCT Mobile X-Ray Systems used in Fluoroscopy and Radiography:
(a) Model SXT-650A; (b) SXT-900A. Recall #Z-795/796-2.
CODE All serial numbers.
MANUFACTURER Toshiba America Medical Systems, Inc., Tustin, California.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
May 19, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 19 units.
REASON Noncompliance with performance standards for x-ray systems in
that they failed to meet all the requirements for source-skin
distance (SSD) and fluoroscopic timer, as well as certification
and identification requirements.
PRODUCT Intertech Anesthesia Breathing Circuit for pediatric use.
Recall #Z-797-2.
CODE Catalog #225-3720-800, lot #01929.
MANUFACTURER Intertech Resources, Inc., Fort Myers, Florida.
RECALLED BY Manufacturer, by letter May 4, 1991. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
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QUANTITY 180 cases (20 units/case) were distributed.
REASON The tubing is subject to splitting which can result in leakage.
PRODUCT IV Administration Sets: (a) Model S75211; (b) Model S75310.
Recall #Z-798/799-2.
CODE Lot numbers: (a) 112445 and 201421; (b) 111540.
MANUFACTURER (a) IVAC Corporation, Creedmoor, North Carolina;
(b) Ensambles Medicos S.A. de CV, Tijuana, B.C. Mexico.
RECALLED BY IVAC Corporation, San Diego, California, by letter February 17,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 33,081 sets were distributed.
REASON The IV sets were distributed with the wrong sensor support
flanges, which may result in miscount of IV solution drops.
PRODUCT Ampro Sterile Latex Surgeons Gloves, 50 outerwrapped pairs per
box. Recall #Z-800-2.
CODE Lot #323B12, size 6-1/2.
MANUFACTURER American Pro Latex, Monmouth, Illinois.
RECALLED BY Manufacturer, by telephone March 30, 1992, followed by letter
March 31, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Oklahoma, Illinois, Puerto Rico.
QUANTITY 2 cases (4 boxes per case) were distributed; firm estimates 1
case remains on the market.
REASON The devices failed the FDA leak test.
PRODUCT Contact lenses under the following names:
(a) NewVues; (b) Focus; (c) Cibasoft Softcolors and Visitint;
(d) Cibathin. Recall #Z-801/804-2.
CODE Lot numbers: (a) 114569, 120066; (b) 115278, 115281, 112524;
(c) 116558, 115210; (d) 115210.
MANUFACTURER Ciba Vision Corporation, Atlanta, Georgia.
RECALLED BY Manufacturer, by letter June 5, 1991. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 28,013 lenses were distributed; firm estimates 27,000 lenses
remain on the market.
REASON NewVues are mislabeled as having a base curve of 8.4 when the
actual curve was 8.8, Focus lenses indicate the wrong power on
the carton, and some broken glass vial fragments were found in
vials of Cibasoft Softcolors, Visitint and Cibathins.
PRODUCT Contact Lens Cleaners, in 1 fluid ounce white plastic bottles
with tamper resistant seal: (a) Fred Meyer Certified
Thimerosal Free Daily Cleaner; (b) Brite-Lite Thimerosal Free
Daily; (c) Good Neighbor Pharmacy Daily Cleaner Thimerosal
Free; (d) Fays Quality Daily Cleaner Easy Rinsing Formula
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Thimerosal Free; (e) Smith's Food and Drug Centers Thimerosal
Free Daily Cleaner. Recall #Z-807/811-2.
CODE Lot number 1021 EXP 4/94.
MANUFACTURER Sherman Laboratories, Inc., Abita Springs, Louisiana.
RECALLED BY KC Pharmaceuticals, Pomona, California, by telephone and by
letter March 5, 1992. Firm-initiated recall complete.
DISTRIBUTION Colorado, Michigan, New York, Oregon, Utah, Virginia.
QUANTITY 15,022 bottles were distributed; firm estimates that little
product remains on the market.
REASON The methods used in, and the facilities and controls used for
their manufacture, packing and storage were not in conformity
with the good manufacturing practice regulations for medical
devices.
UPDATE American Sterilizer 308ORL Surgical Table, Z-742-2 which
appeared as an UPDATE in in the June 17, 1992 Enforcement
Report should read firm-initiated field correction ongoing.
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II
PRODUCT Filaribits Plus (Diethylcarbamazine Citrate/Oxibendazole)
Chewable Tablets, 180 mg/136 mg, packaged in 100 and 200 tablet
bottles, a Rx product for prevention of heartworm and hookworm
and for removal and control of whipworm and mature and immature
stages of intestinal ascarids. Recall #V-038-2.
CODE Lot numbers: 39957020 FEB 1992 (100-tablet bottles),
40738020 FEB (200-tablet bottles).
MANUFACTURER Smithkline Beecham Animal Health, Lincoln, Nebraska.
RECALLED BY Smithkline Beecham Animal Health, West Chester, Pennsylvania,
by telephone April 24, 1992. Firm-initiated recall complete.
DISTRIBUTION Colorado, Missouri, Texas, Florida, Minnesota, Georgia,
California, Wisconsin, Texas, Arkansas.
QUANTITY 347 100-tablet bottles and 12 200-tablet bottles were
distributed.
REASON Product is contaminated with salmonella.
PRODUCT Betavet Soluspan (Betamethasone Acetate and Betamethasone
Sodium Phosphate) packed in 5 ml glass vials, recommended for
the treatment of various inflammatory conditions involving the
joints. Recall #V-044-2.
CODE Lot numbers: 1-AMQ-1 EXP JAN. 93, 1-AMQ-2 EXP JUL. 93,
1-AMQ-3 EXP OCT. 93.
MANUFACTURER Schering Plough Products, Inc., Manati, Puerto Rico.
RECALLED BY Manufacturer, by telephone April 24, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nebraska, New Jersey, Georgia, California.
QUANTITY 89,350 vials were distributed; firm estimates 4,000 vials
remain on the market.
REASON Product found to contain crystal formations.
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PRODUCT Booster Plus NT Medicated (medicated feed) containing
oxytetracycline and neomycin, in 50 pound bags.
Recall #V-045-2.
CODE 3/17/92.
MANUFACTURER Farmers Cooperative Company, Creston, Iowa.
RECALLED BY Manufacturer, by flyer mailed or Faxed March 27, 1992.
Firm-initiated recall complete.
DISTRIBUTION Iowa.
QUANTITY 129 bags were distributed; firm estimates none remains on the
market.
REASON Incorrect formulation - Neo-Terramycin 50/50 was used together
with Neo-Terramycin 100/50 making the product superpotent.
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END OF ENFORCEMENT REPORT FOR JUNE 24, 1992. BLANK PAGES MAY FOLLOW.
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