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
05/05/1993
Recalls and Field Corrections: Foods -- Class III -- 05/05/1993
May 5, 1993 93-18
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
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PRODUCT Kelp Natural Iodine Tablets, packaged in white
opaque plastic bottles of 250. Recall #F-310-3.
CODE 2952 12-94.
MANUFACTURER Contract Pharmacal Corporation, Hauppauge, New
York.
RECALLED BY Quanterron, Inc., Burnsville, Minnesota, by
telephone March 31, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Alabama, Indiana, South Carolina, Texas, Wisconsin.
QUANTITY 132 bottles (11 one-dozen trays) were distributed.
REASON Product is mislabeled - contains 100 tablets in
packages labeled 250 tablets.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
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PRODUCT Peritrate SA (Pentaerythritol Tetranitrate)
Sustained Action Tablets, in bottles of 100
indicated for the relief of angina pectoris. Recall
#D-245-3.
CODE Lot numbers: 16101VA, 07751VA, 07751VB.
MANUFACTURER Warner Lambert, Inc., Vega Baja, Puerto Rico.
RECALLED BY Parke Davis, Division of Warner Lambert Company,
Morris Plains, New Jersey, by letter April 12, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 38,968 units were distributed.
REASON Lot 16101VA does not meet disintegration
specifications.
Lots 07751VA & 07751VB do not meet dissolution
specifications.
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PRODUCT Cytotec (Misoprostol) Tablets, 200 mcg, in unit
dose bottles of 60 and 100, in cartons of 100 unit
dose tablets, and in physician sample packs of 12,
a Rx oral tablet indicated for the prevention
of NSAID-induced gastric ulcers.
Recall #D-246-3.
CODE Lot numbers: 3A382, 3B383, 3B383A, 3B384, 3B386.
MANUFACTURER G.D. Searle & Company, Gaguas, Puerto Rico.
RECALLED BY G.D. Searle & Company, Skokie, Illinois, by letter
April 22, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 39,276 physician samples, 368 unit dose cartons,
21,621 bottles of 100 and 6,128 bottles of 60 were
distributed; firm estimates 60 percent of the
product remains on the market.
REASON Presence of Pseudomonas bacteria.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________
PRODUCT Air-Tite Disposable Syringes, Sterile, 5 ml (cc)
for human and veterinary use, Needle size "21GX1"
(.80x25 mm) for human and veterinary use.
Recall #Z-490-3.
CODE Lot numbers: 90K10, 910412, 91A10.
MANUFACTURER Mesawa Medical Industry Company, Inc., Tokyo,
Japan.
RECALLED BY Air-Tite of Virginia, Inc., Virginia Beach,
Virginia, by letter January 20, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 230,000 pieces were distributed; firm estimates
9,700 pieces remain on the market.
REASON The syringes may leak.
_______________
PRODUCT Sterile Argyle Yankauer Suction Tube with High
Capacity Tip. Recall #Z-491-3.
CODE Lot #445358.
MANUFACTURER Sherwood Medical, Argyle, New York.
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RECALLED BY Sherwood Medical Company, St. Louis, Missouri, by
letter
March 11, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Tennessee, Missouri, Arkansas, Texas, Florida.
QUANTITY 3,200 units were distributed.
The packages may contain microscopic holes which
may compromise their sterility.
_______________
PRODUCT Circulator Boot System, a pneumatic compression
boot system that is used externally on the leg to
augment distal blood flow. Recall #Z-498-3.
CODE All serial numbers.
MANUFACTURER Circulator Boot Corporation, Ardmore, Pennsylvania.
RECALLED BY Manufacturer, by letter July 31, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, Virginia, Massachusetts, Illinois,
Tennessee, New York, Florida, New Jersey, Oklahoma,
Maryland, Missouri, Georgia, California, North
Carolina, Alabama, Washington, D.C., Canada, Saudi
Arabia.
QUANTITY 75 units were distributed.
REASON Movement of the plastic against cloth garments is
cloth garments is capable of generating static
electricity, which may obscure the electro-
cardiographic signal, making it difficult for the
monitor to appropriately time boot compressions.
_______________
PRODUCT Imed Gemini Volumetric Infusion Pump and
Controller:
(a)Model PC-1; (b) PC-2. Recall #Z-504/505-3.
CODE All units manufactured prior to 9/92.
MANUFACTURER IMED Corporation, San Diego, California.
RECALLED BY Manufacturer, by product information February 3,
1993. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide except North Dakota, Rhode Island,
Wyoming, international
QUANTITY Approximately 62,000 units were distributed.
REASON These devices are subject to pumping mechanism
failures which may cause uncontrolled excessive
fluid delivery.
_______________
PRODUCT Aerochamber Flowsignal with Large Mask, Part
#80510,
a nebulizer used to deliver liquids in aerosol form
to patients for breathing. Recall #Z-506-3.
CODE Lot #M7552.
MANUFACTURER Monaghan Medical Corporation, Plattsburgh, New York.
RECALLED BY Manufacturer, by letter January 8, 1993.
Firm-initiated recall ongoing.
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DISTRIBUTION Nationwide.
QUANTITY 209 cases (10 units per case) were distributed.
REASON Stress cracks were found near the "gate" of the
molded adapter where the mask is mated to the body
of the aerochamber, which could result insignificant
leakage of medication from the unit or simply
malfunction of the unit if it cracks completely.
_______________
PRODUCT Cidex Formula 7* Long-Life Activated Dialdehyde
Solution, in 1 gallon containers, a cold
sterilizing solution. Recall
#Z-508-3.
CODE Reorder Code 2750, lot #2802BL.
MANUFACTURER Packaging Corporation of America, Los Angeles,
California.
RECALLED BY Manufacturer, by letter February 17, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Alabama, Arkansas, Arizona, Colorado, Florida,
Georgia, Kansas, Louisiana, Missouri, Mississippi,
North Carolina, New Mexico, Oklahoma, South
Carolina, Tennessee, Texas, Utah.
QUANTITY 208 gallons were distributed.
REASON Foreign material was introduced into some of the
solution. It is evident as small whitish,
wax-like particles.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________
PRODUCT Colottrac CWB Controls (Citrated Whole Blood
Controls), a lyophilized, citrated whole blood
sample which can be used to verify the performance
of the Automated Coagulation Timer and the
applicable test cartridges. Recall #Z-488-3.
CODE Lot #407311-200.
MANUFACTURER Medtronic HemoTec, Inc., Englewood, Colorado.
RECALLED BY Manufacturer, by telephone February 5, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION New York, Indiana, Texas, Louisiana, California,
Tennessee, Arizona, Colorado, Illinois, South
Carolina, New Mexico, Florida, Oregon, Kentucky,
Pennsylvania, Montana, Canada.
QUANTITY 1,035 controls were distributed.
REASON The controls will produce results which are outside
the clotting time ranges printed on the package
insert for each cartridge type.
_______________
PRODUCT Goldenberg Incus Prosthesis, 4.2 mm long, 1.15 mm
cannulation, hydroxylapatite/plastic-pore, an
implantable inner ear prosthesis. Recall #Z-489-3.
-4-
CODE Lot #3B23766, packaged date 7/92.
MANUFACTURER Smith & Nephew Richards, Inc., Medical Specialties
Division, Bartlett, Tennessee.
RECALLED BY Smith & Nephew Richards, Inc., Memphis, Tennessee,
by issuing inner-office memorandum "stock alert"
dated November 12, 1992. Firm-initiated recall
complete.
DISTRIBUTION Nationwide, Canada, France, Germany, England,
Holland.
QUANTITY 25 units were distributed.
REASON The immediate package container was mislabeled as a
Shea Porp prosthesis.
_______________
PRODUCT Novalens (Rosilfocon A) Rigid Gas Permeable Contact
Lenses and Lens Buttons used in the manufacture of
Novalens. Recall #Z-492/493-3.
CODE Lenses with identification number ending with 147
through 176 and buttons manufactured from June 26,
1992 through January 15, 1993.
MANUFACTURER Ocutec Corporation, Morrisville, North Carolina.
RECALLED BY Manufacturer, by letter March 18, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 11,757 buttons were used in making contact lenses
distributed by Ocutec Corporation.
REASON Products were distributed without an approved
supplement to their premarket approval for the
manufacturing site.
_______________
PRODUCT Baxter S/P Caraway Capillary Tubes, Heparinized,
350 Microliter Volume, used for micro blood sample
collection. Recall #Z-503-3.
CODE Lot 562 EXP 3/31/95.
MANUFACTURER Chase Instruments Corporation, Rockwood, Tennessee.
RECALLED BY Manufacturer, by telephone March 26, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION California, Georgia, Illinois, Louisiana, Maryland,
North Carolina, Ohio, Texas.
QUANTITY 36 cases (100 tubes per package, 6 packages per
case) were distributed; firm estimates none remains
on the market.
REASON The pH of heparin solution that is applied to the
inner surface of the tubes was found to be out of
established pH limits, due to contaminated water.
_______________
PRODUCT Tryptic Soy Agar (Rodac) Contact Plate. Recall
#Z-507-3.
CODE Product #C6050, lot #7869 EXP 3/10/93.
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MANUFACTURER Micro Diagnostics, Inc., Lombard, Illinois.
RECALLED BY Manufacturer, by telephone December 15, 1992. Firm-
initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 33 cartons (10 plates per carton) were distributed.
Firm estimates that none of the product remains on
the market.
REASON The plates had trace contamination due to poor
aspetic technique during manufacture.
UPDATE Nellcor N-1000 Pulse Oximeter/ECG Monitor Manual.
Recall #Z-476-3, which appeared in the April 28,
1993
Enforcement Report should read:
Manufacturer: Nellcor, Inc., Chula Vista,
California.
Recalled by: Nellcor, Inc., Hayward, California, by
letter December 23, 1991.
SEIZURES
_______________
Product: Canned plum tomatoes (92-643-324).
Charges: Adulterated - The article is unfit for food because
it is contained in swollen cans which show evidence
of detinning and the presence of hydrogen gas.
Misbranded - The article package form and its label
fails to bear an accurate statement of quantity of
contents in terms of weight.
Firm: DiNucci Foods, Inc., Perth Amboy, New Jersey.
Filed: February 18, 1993; U.S. District Court for
the District of New Jersey; Civ. #93-693;
FDC #66664.
Seized: March 11, 1993 - goods valued at approximately
$12,000.
_______________
Product: Various microassay test kits and accompanying
labeling (92-594-961/70).
Charge: Adulterated - The articles are class III medical
devices which do not have the required approved
premarket approval applications.
Firm: Diamedix Corporation, Miami, Florida.
Filed: March 24, 1993; U.S. District Court for the Southern
District of Florida; Civ.#93-0574-
CIV-UNGARO-BENAGES; FDC #66465.
Seized: April 6, 1993 - goods valued at approximately $4
million.
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END OF ENFORCEMENT REPORT FOR MAY 5, 1993. BLANK PAGES MAY FOLLOW.
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