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
01/13/1993
Recalls and Field Corrections: Drugs -- Class II -- 01/13/1993
January 13, 1993 93-2
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Lortab 7.5/500 Tablets CIII (7.5 mg hydrocodone bitartrate and
500 mg acetaminophen). RecallD-093-3.
CO 920409D EXP 4/94.
MANUFACTURER Mikart, Inc., Atlanta, Georgia.
RECALLED BY Whitby Pharmaceuticals, Inc., Richmond, Virginia (responsible
firm), by letter December 4, 1992. Firm-initiated recall
ongoing
DISTRIBUTION Nationwide.
QUANTITY 4,696 100-tablet unit dose packages (each containing 4
25-tablet packages) were distributed.
REASON A carton labeled as 5 mg Lortab contained correctly labeled
labeled unit dose 7.5 mg.
PRODUCT Medical Oxygen Cylinders, USP, in D, E and F (F same as C)
sized metal cylinders. RecallD-099-3.
CODE LotA02 C344, EXP 12/97.
MANUFACTURER Mountain Airgas Medical Division, Salt Lake City, Utah.
RECALLED BY Manufacturer, by telephone December 23, 1992, followed by
letter. Firm-initiated recall ongoing.
DISTRIBUTION Utah.
QUANTITY 149 cylinders were distributed; firm estimates that 40% of the
lot may still remain on market.
REASON One cylinder contained trace quantities of chlorine.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Lasix (furosemide) Oral Solution, 60 ml, in brown glass bottle
10 mg/ml, a Rx diuretic used in treatment of edema.
RecallD-094-3.
CODE Lot0630011 EXP 4/94.
MANUFACTURER Hoechst-Roussel Pharmaceuticals, Inc., Somerville, New Jersey.
RECALLED BY Manufacturer, by letter dated April 27, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 28,225 bottles were distributed. Firm estimates none remains
on the market.
REASON Presence of cardboard particles.
PRODUCT Ventolin (Albuterol, USP), Inhalation Aerosol, 6.8 g, 80
metered inhalations, a professional sample for use with the
blue Ventolin Inhalation Aerosol Actuator. RecallD-095-3.
CODE Lot numbers: Z31572KS EXP 11/94, Z31582KS EXP 12/94.
MANUFACTURER Glaxo, Inc., Zebulon, North Carolina.
RECALLED BY Manufacturer, by letter November 24, 1992. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 87,503 cans of lot Z31572KS and 87,452 cans of lot Z31582KS
were distributed.
REASON Some units were packaged with a Beclovent actuator.
PRODUCT Cortisone Acetate, 25 mg, packaged under the following labels:
Richlyn, in bottles of 100; Rugby, in bottles of 100 and 500;
and URL, in bottles of 100. RecallD-096-3.
CODE Lot 44783 packaged under Richlyn, Rugby and URL labels and lot
44784 packaged only under the Rugby label.
MANUFACTURER Richlyn Laboratories, Inc., Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by letter September 28, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION New York, Florida, New Jersey, Connecticut, Illinois,
California, Ohio, Pennsylvania, Georgia.
QUANTITY 448,300 tablets of lot 44783 and 468,500 tablets of lot 44784
were distributed; firm estimates that very little of this
product remains on market.
REASON Some tablets are debossed with an incorrect NDC number.
PRODUCT Ibuprofen 200 mg, in 1000 tablet containers, an analgesic
drug. RecallD-097-3.
CODE LotJ03292 EXP 8/95.
-2-
MANUFACTURER Interpharm, Inc., Plainview, New York.
RECALLED BY Manufacturer, by telephone and letter November 17, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Texas, Ohio.
QUANTITY 200 bottles were distributed.
REASON Label declares an incorrect lot number.
PRODUCT Ibuprofen, 600 mg, in 500 tablet bottles, an analgesic drug.
RecallD-098-3.
CODE LotA00291 EXP 12/93.
MANUFACTURER Interpharm, Inc., Plainview, New York.
RECALLED BY Manufacturer, by telephone November 17, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 989 bottles were distributed.
REASON Product exceeds ANDA specifications for degradation product.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT (a) Red Blood Cells; (b) Plasma. RecallB-050/051-3.
CODE Unit numbers 20GG42606, 20GG42610.
MANUFACTURER American Red Cross, Boise, Idaho.
RECALLED BY Manufacturer, by telephone September 14, 1992 and by letter
dated September 16, 1992. Firm-initiated recall complete.
DISTRIBUTION Idaho, California.
QUANTITY 2 units of each component.
REASON Blood products which tested initially reactive for the
hepatitis B surface antigen (HBsAg) were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT (a) Red Blood Cells; (b) Plasma. RecallB-052/053-3.
CODE Unit numbers: (a) 20GG42605, 20GG42607, 20GG42608, 20GG42609,
20GG42611, 20GG42613, 20GG42614, 20GG42619;
(b) 20GG42605, 20GG42607, 20GG42608, 20GG42609, 20GG42613,
20GG42614, 20GG42619;
MANUFACTURER American Red Cross, Boise, Idaho.
RECALLED BY Manufacturer, by telephone September 14, 1992 and by letter
dated September 16, 1992. Firm-initiated recall complete.
DISTRIBUTION Idaho, California.
QUANTITY (a) 8 units; (b) 7 units.
REASON Blood products which tested initially reactive for the
hepatitis B surface antigen (HBsAg) were distributed.
PRODUCT (a) Whole Blood; (b) Recovered Plasma. RecallB-102/103-3.
CODE Unit numbers: (a) 1150827; (b) 1148318.
MANUFACTURER Houchin Community Blood Bank, Bakersfield, California.
-3-
RECALLED BY Manufacturer, (a) by telephone July 21, 1992; (b) by letter
dated September 17, 1992. Firm-initiated recall complete.
DISTRIBUTION (a) California; (b) Delaware.
QUANTITY 1 unit of each component.
REASON Blood products labeled with the incorrect expiration date, or
collected from an augologous donor who did not meet the
criteria for homologous donation, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Dermabrader Centrifugal Chuck, Part1360-4, used to "sand or
plane" the elevated surface of the skin in order to minimize
the effects of a scar or blemish. RecallZ-178-3.
CODE All lots produced in April 1992.
MANUFACTURER Stryker Corporation, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter September 23, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Ecuador, The Netherlands, United Kingdom.
QUANTITY 10 units were distributed.
REASON The device may not be packaged with the correct warning insert.
PRODUCT Lorad M-III Breast Imaging System -- Mammography system device,
a radiological device intended for diagnostic breast imaging.
RecallZ-179-3.
CODE All M-III units manufactured before 9/23/91.
MANUFACTURER Lorad Medical Systems, Danbury, Connecticut.
RECALLED BY Manufacturer, by sending field modification instruction (FMI)
during the period of mid September 1991, to mid October 1991,
to all dealer home offices which purchased and M-III unit which
was manufactured before 9/23/91. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide, Canada, Australia, Sweden.
QUANTITY 137 units were distributed.
REASON The breast compression device continues to drive downward after
failure of a device fuse.
PRODUCT Atrium - Water Seal, Chest Drainage Unit, (multiple purpose
system), a sterile, Rx medical device intended to help drain
fluids and air from the pleural cavity or mediastinum during or
after thoracic surgery. RecallZ-185-3.
CODE Model2060-000, lot260283-000.
MANUFACTURER Atrium Medical Corporation, Hollis, New York.
RECALLED BY Manufacturer, by letter October 28, 1992. Firm-initiated
recall complete.
DISTRIBUTION South Carolina, Kentucky, Minnesota.
QUANTITY 132 units were distributed.
REASON Some units were assembled with a body with two openings for
patient drain tubes instead of one.
-4-
PRODUCT Transcutaneous Electrical Nerve Stimulators (TENS devices),
promoted for auriculotherapy:
(a) Stim Flex Model 400; (b) Stem Flex Model 200;
(c) Stem Flex Model 80. RecallZ-187/189-3.
CODE All serial numbers.
MANUFACTURER Electro Medical, Inc., Tulsa, Oklahoma.
RECALLED BY Manufacturer, by letter October 28, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 950 units were distributed.
REASON Products are prescription devices which were distributed
without prescription legends. Models 200 and 400 are
preamendment devices. Model 80 is being distributed without
premarket approval authority.
PRODUCT CM5000 Airway Pressure Monitor, also referred to as CM5000 APM,
intended to monitor pressurized breathing circuits as in lung
ventilator systems. RecallZ-190-3.
CODE LotL959, serial numbers: 5060, 5195, 5426, 6280, 7268, 7354,
7273-7282, 7284-7292.
MANUFACTURER Canadian Monaghan, Ltd., London, Ontario Canada.
RECALLED BY Monaghan Medical Corporation, Plattsburgh, New York, by
telephone June 3, 1992, followed by letter. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania, Ohio, New York, Massachusetts, North Carolina.
QUANTITY 20 units were distributed; firm estimates none remains on
market.
REASON Incorrect wiring may cause the remote alarm not to function.
PRODUCT Ritter Examination Tables: (a) Model 98; (b) Model 99.
RecallZ-196/197-3.
CODE Serial numbers: CN1000 through CN1399.
MANUFACTURER Midmark Corporation, Versailles, Ohio.
RECALLED BY Manufacturer, by letter August 31, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 400 tables were distributed; 374 of the tables are still in use.
REASON Table may not be able to safely support a heavy patient.
UPDATE McGaw Hyperformer System, RecallZ-144-3, which appeared in
the December 30, 1992, Enforcement Report should read:
CODE: Units within the serial number range G1000 through
G1403. Only units with software versions E and EC1 are
involved in the recall.
-5-
MEDICAL DEVICE SAFETY ALERTS:
PRODUCT ACS Spectrum Coronary Dilatation catheters:
(a) Catalog No. 10070-107, 1.5 mm diameter;
(b) Catalog No. 10071-107, 2.0 mm diameter;