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
07/02/1992
RECALLS AND FIELD CORRECTIONS: July 2, 1992
FOODS - CLASS I
92-27
PRODUCT Su Turkish Apricots, dried, in 10 pound boxes. Recall #F-336-2.
CODE All product distributed prior to 3/12/92.
MANUFACTURER Blooming Prairie Natural Foods, Minneapolis, Minnesota.
RECALLED BY Manufacturer, by letter March 27, 1992. Firm-initiated recall
complete.
DISTRIBUTION Minnesota, Iowa, South Dakota, Wisconsin.
QUANTITY Approximately 700 pounds were distributed.
REASON Product contains undeclared sulfites.
PRODUCT Salinas brand Vacuum Packed Smoked Milkfish, 1 to 1.5 pounds.
Recall #F-337-2.
CODE None.
MANUFACTURER Salinas Foods Import, Woodside, New York.
RECALLED BY Manufacturer, by letter April 9, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION New York, New Jersey.
QUANTITY Approximately 200 cases (35 pieces per case) were manufactured;
firm estimates 25 cases remain on the market.
REASON Potential for Clostridium botulinum toxin.
PRODUCT Captain D's brand Ready-To-Eat Frozen Seafood Salad, in 1-1/2
pound aluminum pans. Recall #F-351-2.
CODE None.
MANUFACTURER Shaw's Southern Belle Frozen Foods, Inc., Jacksonville, Florida.
RECALLED BY Manufacturer, by telephone February 11, 1992. Firm-initiated
recall complete.
DISTRIBUTION Southeast United States.
QUANTITY 2 cases were distributed.
REASON Product was contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT Harvest of Eden brand Mushrooms, pieces and stems, in 68 ounce
cans (drained weight). Recall #F-350-2.
CODE Three line code: MPS/TC/1Y28.
MANUFACTURER Tak Chance, Hong Kong.
RECALLED BY Rema Foods, Inc., Teaneck, New Jersey, by letter May 13, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION New York, New Jersey, Pennsylvania, Ohio, Oklahoma, Wisconsin,
Maine.
QUANTITY 1,600 cases (6 cans per case) were distributed.
REASON Product is contaminated with Staphylococcus enterotoxin.
PRODUCT Various flavors of cookie dough:
(a) Original Cookie Dough
(b) Pecan Cookie Dough
(c) Oatmeal Cookie Dough
(d) Double Fudge Cookie Dough
(e) Brownie Cookie Dough
(f) Peanut Butter Cookie Dough
(g) White Macadamia Cookie Dough
(h) Dark Macadamia Cookie Dough
(i) Cheesecake Cookie Dough
(j) Sugar Cookie Dough
(k) Jumbo Cookie Dough
(l) Caramel Pecan Cookie Dough. Recall #F-352/363-2.
CODE Dates including and beginning with 011392 through 020292.
MANUFACTURER Great American Chocolate Chip Cookie Company, Inc., Atlanta,
Georgia.
RECALLED BY Manufacturer, by telephone February 19, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, Gaum.
QUANTITY 21,946 cases were distributed; firm estimates none remains on
the market.
REASON Product was contaminated with metal particles.
PRODUCT SSIPS brand Awesome Orange Coolers. Recall #F-364-2.
CODE Lot 097A1 printed on bottom of container.
MANUFACTURER Johanna Farms, Inc., Flemington, New Jersey.
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RECALLED BY Manufacturer, by telephone May 26 & 27, 1992, general news
media May 28 & 29, 1992, and by letter May 29, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION New Jersey, Pennsylvania, New Hampshire, Delaware.
QUANTITY 8,640 units were distributed.
REASON Product is contaminated with sanitizing solution (sodium
hydroxide).
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT Various food supplements manufactured and distributed in bulk
containers: (a) High Protein Chocolate Tablets; (b) High
Protein Vanilla Tablets; (c) Gain Weight Vanilla Tablets; (d)
Special Tablets; (e) One Daily Vitamin Supplement with Iron
Tablets. Recall #F-343/347-2.
CODE Lot numbers 8762 through 8791 for food supplement products and
lot #56203 for the vitamin supplement with iron.
MANUFACTURER High Chemical Company, Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by telephone May 20, 1992. Firm-initiated recall
complete.
DISTRIBUTION Unknown.
QUANTITY Firm estimates none remains on the market.
REASON Products were contaminated with rodent filth.
PRODUCT 4C All Natural brand Grated Parmesan Cheese, in 8 ounce
paperboard containers. Recall #F-348-2.
CODE OCT259341, OCT259342.
MANUFACTURER 4C Foods Corporation, Brooklyn, New York.
RECALLED BY A.A. Green Company, Inc., also known as Hester & Connley,
Jacksonville, Florida, by visit beginning March 2, 1992.
Firm-initiated recall complete.
DISTRIBUTION Florida, Georgia.
QUANTITY 11,232 containers were distributed; firm estimates none remains
on the market.
REASON Product was contaminated with mold.
PRODUCT Nobility brand Mandarin Oranges, 11 ounces. Recall #F-349-2.
CODE All product with P on the top of the can.
MANUFACTURER Unknown. Product of People's Republic of China.
RECALLED BY Mitsui Foods, Hackensack, New Jersey (importer), by telephone
March 1, 1992. Firm-initiated recall complete.
DISTRIBUTION Southeastern states from North Carolina to Florida.
QUANTITY 11,524 cases (24 cans per case) were distributed.
REASON Product was contained in swollen cans.
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RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
PRODUCT Metaproterenol Sulfate Inhalation Solution, USP 5%,
Sulfite-Free; a Rx oral inhalation bronchodilator for treatment
of bronchial asthma; in 1 fluid ounce (30 ml) vial, for use
with a hand-bulb nebulizer or IPPB apparatus, packaged under
the following labels: PBI, Goldline, H.L. Moore, Qualitest,
Rugby, Dey. Recall #D-397-2.
CODE All unexpired lots (13 lots).
MANUFACTURER Pharmaceutical Basics, Inc. (PBI), Morton Grove, Illinois.
RECALLED BY Manufacturer, by letter May 27, 1992 and June 1, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 100,781 units were distributed; firm estimates 20,000 units
remain on the market.
REASON Microbial growth, Pseudomonas gladioli/cepacia.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Pro-Banthine Tablets, propantheline bromide USP, 7.5 mg tablets
and 15 mg tablets, a Rx oral tablet used as adjunctive therapy
in the treatment of peptic ulcer, packaged as follows:
(a) 7.5 mg in 100 tablet bottles;
(b) 15 mg in 100 tablet unit dose boxes. Recall #D-399/400-2.
CODE Lot numbers: (a) 0990-418 and 0990-419 EXP 9/92;
(b) 0590-483 and 0590-485 EXP 5/93.
MANUFACTURER Searle & Company, Inc., Caguas, Puerto Rico
RECALLED BY Schiapparelli Searle, a joint venture of Searle
Pharmaceuticals, Inc., Skokie, Illinois, by letter dated June
19, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 16,510 bottles and 1,383 unit dose cartons were distributed.
REASON Subpotency.
PRODUCT Various Rx injectable drug products:
(a) Gentamicin Sulfate Injection, USP (Pediatric), 10 mg/ml, in
2 ml multiple dose vials, an injectable antibiotic;
(b) Heparin Lock Flush Solution, USP, 100 USP units/ml, for
cleaning intermittent infusion sets;
(c) Lidocaine HCl Injection, USP, 1%, 10 mg/ml, in 2 ml single
dose vials, a local anesthetic for infiltration and nerve
block. Recall #D-401/403-2.
CODE Lot numbers: (a) 320148 EXP 2/94; (b) 311367 EXP 12/93;
(c) 320057 EXP 7/93.
MANUFACTURER Lyphomed, Division of Fujisawa USA, Inc., Grand Island,
New York.
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RECALLED BY Lyphomed, Division of Fujisawa USA, Inc., Melrose Park,
Illinois, by letter June 12, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 87,775 vials were distributed; firm estimates 10,000 vials
remain on the market; (b) 241,100 vials were distributed; firm
estimates 60,000 vials remain on the market; (c) 120,900 vials
were distributed; firm estimates 61,000 vials remain on the
market.
REASON The vials have a low fill volume.
UPDATE An UPDATE listed in the June 24, 1992 Enforcement Report for
Recall #D-365/371-2 should have read:
Various injectable drug products, manufactured by Lyphomed,
Division of Fujisawa USA, Inc., 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 Diazoxide Injection, USP, 15 mg/ml, in 20 ml single dose vials,
a Rx antihypertensive. Recall #D-404-2.
CODE Lot numbers: 120026 EXP 7/93 and 111249 EXP 6/93.
MANUFACTURER Lyphomed, Division of Fujisawa USA, Inc., Melrose Park,
Illinois.
RECALLED BY Manufacturer, by letter June 17, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,761 vials were distributed; firm estimates 2,380 vials remain
on the market.
REASON The pH is below USP limits prior to expiration date.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
PRODUCT (a) Model 2000W Heart/Respiration Monitors;
(b) Model 2000W Heart/Respiration Monitors with Option H;
Model 700 Recorder/Monitors. Recall #Z-708/710-2.
CODE Serial numbers:
(a) 4195 4309 6451 20179 20218
20596 20701 20746 20932 21003
21004 21300 21359 21387 21390
21410 21635 21906 22455 22512
22554 22626 22772 22818 23003
23472 23528 23616 23661 23950
24334 24610 24814 20497 20589
21338 21644 21832 22196 22159
23181 23182 23548 22901 23778
23838 24580 24603
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(b) 4513 5349 4861 6279 4753
(c) 70001.
MANUFACTURER EdenTec, Eden Prairie, Minnesota.
RECALLED BY Manufacturer by telephone beginning May 1, 1992, followed by
letter May 4, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 53 monitors and 1 recording device containing a monitor were
distributed.
REASON The devices contain a defective circuit board which may cause
the apnea alarm to sound inadequately.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT CDI Cells, flow through devices inserted directly into the
extracorporeal tubing circuit, sterile and individually
packaged for cut-in at the time of use or as part of custom
tubing pack:
(a) Model 6631 Pouch; (b) Model 6641 Pouch; (c) Model 6651 Case;
(d) 6731 Pouch; (e) Model 6741 Pouch; (f) Model 6751 Case.
Recall #Z-628/633-2.
CODE All lot numbers of all models.
MANUFACTURER CDI, 3M Healthcare, Tustin, California.
RECALLED BY Manufacturer, by telephone beginning December 18, 1991,
followed by letters dated and sent December 18, 1991 through
January 15, 1992. Firm-initiated recall complete.
DISTRIBUTION Alabama, California, Florida, Illinois, Kentucky, Louisiana,
Massachusetts, Missouri, Mississippi, North Carolina, New
Jersey, Nevada, New York, Texas, Virginia, West Virginia.
QUANTITY (a) 1,510 units; (b) 2,460 units; (c) 1,390 units; (d) 1,370
units; (e) 1,290 units; (f) 70 units were distributed; firm
estimates none remains on the market.
REASON The film/paper pouch used to package these devices may be
punctured or damaged during normal shipping and handling,
compromising the sterility of the devices.
PRODUCT SpermPrep medium, a sterile solution used for the in-vitro
washing of sperm before it is introduced into the uterus:
(a) SpermPrep Medium, in 12 ml glass vials, Catalog #SPM-12;
(b) SpermPrep Medium, in 100 ml glass bottles, Catalog #SPM-100.
Recall #Z-805/806-2.
CODE Lot numbers: (a) BSA-4151; (b) BSA-4152.
MANUFACTURER Quelab Laboratories, Inc., Montreal, Canada.
RECALLED BY Fertility Technologies, Natick, Massachusetts, by telephone
December 8, 1991 followed by letter December 27, 1991.
Firm-initiated recall complete.
DISTRIBUTION Nationwide, Spain.
QUANTITY (a) 251 units; (b) 5 units were distributed.
REASON The sterility of the product has been compromised as evidenced
by loss of package integrity or lack of adequate
sterilization. Mold was found on the rubber stopper of the 12
ml vial.
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PRODUCT Nicolet Viking Electrodiagnostic Systems, used to perform
routine and computer-aided electromyography, evoked potential
studies, and nerve condition studies:
(a) Nicolet Viking; (b) Nicolet Viking LE; (c) Nicolet Viking
II. Recall #Z-812/814-2.
CODE Serial numbers: (a & b) 860106 through 919188 (not inclusive);
(c) 900101 through 920748 (not inclusive).
MANUFACTURER Nicolet Instrument Corporation, Madison, Wisconsin.
RECALLED BY Manufacturer, by letter dated April 10, 1992. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide, Belgium, Canada, France, Germany, Japan, Mexico,
The Netherlands, Switzerland, The United Kingdom.
QUANTITY Approximately 1,066 units were distributed. All units shipped
after February 6, 1992 have been modified.
REASON Under certain conditions, it is possible that patient burns can
occur at electrode sites.
PRODUCT MRT-35 Magnetic Resonance Imaging System using Software Version
4.01C, used to facilitate the interface of the MRT-35 operator
and the system. Recall #Z-815-2.
CODE Serial numbers range from Q-0007 to Q00276.
MANUFACTURER Toshiba America MRI, Inc., South San Francisco, California.
RECALLED BY Manufacturer, by letter March 30, 1992. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide, Germany, Switzerland, People's Republic of China.
QUANTITY 142 software systems were distributed.
REASON Software Version 4.01C contains a defect whereby an image that
is displayed on the screen prints the correct run number and
image, but not the correct patient name.
PRODUCT X-Ray Controls for Fluoroscopic X-Ray Systems with Pulsed
Fluoroscopy Adaptor PFA-01A:
(a) Model KXO-2050; (b) Model KXO-80 A/B;
(c) Model KXO-80-C/D. Recall #Z-819/821-2.
CODE All serial numbers.
MANUFACTURER Toshiba Medical Systems, Inc., Tustin, California.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
June 10, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 150 units were distributed.
REASON The recording device was not interlocked with the higher
exposure rates as required.
PRODUCT 7200 Series Microprocessor Ventilator, used to enable a
respiratory care practitioner to provide a patient with
ventilatory assistance. Recall #Z-822-2.
CODE All 7000 series models, (7200AE, 7200SPE, 7200E) and all serial
numbers of ventilators shipped from 9/9/91 to 1/31/92.
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MANUFACTURER Puritan-Bennett Corporation, Carlsbad, California.
RECALLED BY Manufacturer, by letter March 20, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,309 units were distributed.
REASON A 5.0 amp fuse instead of a 0.5 amp fuse was installed in the
ventilator's utility panel harness, which could potentially
cause a diode to open, resulting in loss of power alarm and
overheating of electrical components.
PRODUCT Cryo High Pressure Hoses, intended for those users that do not
have the Cryo carrier (use with CR4000 consoles), used for
connecting the CR4000 consoles to either a nitrous oxide or
carbon dioxide non-syphon gas cylinder:
(a) 60" Cryo High Pressure Hose, Part #P350003;
(b) 30" Cryo High Pressure Hose, Part #P350007.
Recall #Z-829/830-2.
CODE Lot #139366.
MANUFACTURER Furon Company, Synflex Division, Mantua, Ohio.
RECALLED BY Mira, Inc., Waltham, Massachusetts, by telephone February 14,
1992 followed by letter dated April 3, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Brazil, Australia, South Africa, Peru, Canada,
Syria, Egypt, Bulgaria, Japan, Austria.
QUANTITY (a) 55 units; (b) 15 units were distributed
REASON The outer jacket of the hose was not properly perforated to
allow the gas to leave the hose.
PRODUCT (a) de-Stat 3 Liquid Cleaning/Disinfecting and storage
solution, in 4 fluid ounce and 1 fluid ounce plastic bottles,
for fluoro/silicone acrylate and silicone acrylate (REP)
contact lenses;
(b) Sof/Pro-Clean (s.a.) daily cleaner for soft (hydrophilic)
contact lenses, in 1 fluid ounce plastic bottles.
Recall #Z-831/832-2.
CODE Lot numbers and EXP dates:
(a) 0870 EXP 4/93, 1020 EXP 4/93, 1100 EXP 5/93, 1840 EXP 7/93,
2070 EXP 7/93, 2370 EXP 8/93, 2410 EXP 8/93, 2810 EXP 10/93,
3020 EXP 10/93, 3520 EXP 12/93, 0621 EXP 3/94, 0921 EXP 4/94,
0991 EXP 4/94, 1831 EXP 7/94, 2121 EXP 8/94, 2331 EXP 8/94;
(b) 0022 EXP 1/95.
MANUFACTURER Sherman Pharmaceuticals, Inc., Abita Springs, Louisiana.
RECALLED BY Manufacturer, (a) by letter October 15, 1991; (b) by letter
April 16, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Israel, Korea.
QUANTITY Approximately (a) 115,000 units; (b) 6,815 units were
distributed.
REASON The de-Stat product was mislabeled. The firm also removed the
sodium bisulfite component from the Sof/Pro-Clean product
without an approved supplement to its PMA.
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UPDATE Contact lenses under the following names:
(a) NewVues; (b) Focus; (c) Cibasoft Softcolors and Visitint;
(d) Cibathin. Recall #Z-801/804-2, which appeared in the June
24, 1992 should read:
RECALLED BY Manufacturer, by letter June 5, 1991. Firm-initiated recall
completed November 1991 with return product destroyed.
QUANTITY Firm estimates none remains 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 vial pieces were found in vials of
Cibasoft Softcolors, Visitint and Cibathins.
MEDICAL DEVICE SAFETY ALERT
PRODUCT (a) Multi-sized Double Lumen Percutaneous Intra-Aortic Balloons
(IABs): 30 cc (8F), 40 cc (9F), 50 cc (10F), 40 cc (10.5F);
(b) Double Lumen IAB for Sheatless: 40 cc (9F S);
(c) Flexi-Cath Lumen Catheter: 9.5F.
Safety Alert #M-057/059-2.
CODE All lot numbers before 3/12/91.
MANUFACTURER Kontron Instruments, Inc., Everett, Massachusetts.
ALERTED BY Manufacturer, by letter May 22, 1992.
DISTRIBUTION Nationwide and international.
QUANTITY 17,407 units were distributed; firm estimated that 2,611 units
remained on the market as of 9/30/91.
REASON The firm's May 22, 1992 letter informs users of a problem with
helium leaks at the bifurcation/metal luer of the device and
provides the user with information including problem
recognition and correction.
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END OF ENFORCEMENT REPORT FOR JULY 1, 1992. BLANK PAGES MAY FOLLOW.
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