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
08/11/1993
Recalls and Field Corrections: Foods -- Class II -- 08/11/1993
August 11, 1993
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
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PRODUCT Mead Johnson Nutramigen brand Infant Formula, 20
calories/fluid ounce, in 3 ounce glass nursettes.
Recall #F-480-3.
CODE MME01 expires 1JUL93.
MANUFACTURER Mead Johnson Nutritionals, Evansville, Indiana.
RECALLED BY Manufacturer, by bulletin May 24, 1993, and by visits
completed by June 3, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Canada.
QUANTITY 102,048 bottles were distributed.
REASON The product was contaminated with glass particles.
_______________
PRODUCT Carnation brand (a) Diet Breakfast Products, Chocolate; (b)
Diet Breakfast Product in the following flavors: Chocolate,
Chocolate Malt, Artificial Vanilla, and Artificial
Strawberry, packaged in paper packages with 8 packages per
retail paper carton, Recall #F-557/558-3.
CODE Lot numbers: 2356WW01, 2357WW01, 2358WW01, 2363WW01,
2364WW01, 2365WW01.
MANUFACTURER Nestle Food Company, Waverly, Iowa.
RECALLED BY Manufacturer, by telephone January 21, 1993, followed by
visit. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 3,825 cases; (b) 128 cases were distributed.
REASON Products contain undeclared egg white solids.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
=======================
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PRODUCT Pure Extract Vanilla Golden, in 4, 8, 16, and 32 fluid ounce
bottles and in 1 gallon and 50 gallon containers.
Recall #F-555-3.
CODE All lots.
MANUFACTURER Panamerican de Occidente, S.A. de C.V., Guadalajara,
Jalisco, Mexico.
RECALLED BY Chileros Mexicanos, Inc., (Mi Hacienda Productos), by letter
June 10, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY Undetermined.
REASON Product does not meet the standard of identify for vanilla
extract.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
========================
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PRODUCT Amoxicillin Chewable Tablets, USP, 250 mg, in bottles of
100, Rx antibiotic, under the following labels: Qualitest,
Major, Goldline, Rugby, Biocraft. Recall #D-305-3.
CODE Lot #31144 EXP 11/1/94.
MANUFACTURER Biocraft Laboratories, Inc., Elmwood Park, New Jersey.
RECALLED BY Biocraft Laboratories, Inc., Fair Lawn, New Jersey, by
telephone April 26 & 27, 1993. Firm-initiated recall
complete.
DISTRIBUTION Alabama, California, Florida, Illinois, Kentucky, Michigan,
New York, Rhode Island.
QUANTITY 6,139 bottles were distributed.
REASON Use of unapproved manufacturing procedures.
_______________
PRODUCT Hydrocortisone 1% and Acetic Acid 2% Otic Solution, USP 10
ml bottle, Rx for the treatment of superficial infections of
the external auditory canal, under the following labels:
Genetco, Qualitest, Beta Dermaceuticals, H.L. Moore, Aligen,
Major, C.O., Truxton, IDE, Rugby, Geneva, Goldline, Schein,
Harber, URL, UDL. Recall #D-307-3.
CODE All lot numbers.
MANUFACTURER Thames Pharmacal Company, Inc., Ronkonkoma, New York.
RECALLED BY Manufacturer, by telephone July 19-21, 1993, followed by
letter July 22, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates 15,000 bottles remain on the market.
REASON Subpotency of the acetic acid ingredient.
_______________
PRODUCT Technetium Tc-99m Generator, diagnostic imaging agent.
Recall #D-308-3.
CODE Lot #9249-5F-333.
MANUFACTURER The Dupont Merck Pharmaceutical Company, Radiopharmaceutical
Division, No. Billerica, Massachusetts.
RECALLED BY Manufacturer, by telephone and by letter December 14, 1992.
Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit was distributed.
REASON Non-sterility.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
=======================
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PRODUCT Thiothixene HCL Oral Solution, USP, concentrate, in 30 ml
and 120 ml bottles, used in the management of psychotic
disorders, under the Barre and Goldline labels.
Recall #D-306-3.
CODE Lot 03909 EXP 1/93 and 13461 EXP 9/93.
MANUFACTURER Barre-National, Inc., Baltimore, Maryland.
RECALLED BY Manufacturer, by letter October 29, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 25,948 bottles were distributed.
REASON Product below specification for alcohol content.
_______________
PRODUCT Thiopental Sodium for Injection, 400 mg and 500 mg
strengths, in 20 ml vials, for use as induction anesthetic.
Recall #D-309/310-3.
CODE All lots.
MANUFACTURER International Medication Systems, Ltd., South El Monte,
California.
RECALLED BY Manufacturer, by letter July 6, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 19,149 units of stock #5040 and 544,839 units of stock #5050
were distributed.
REASON Product may form a precipitate after reconstitution.
_______________
PRODUCT Phenazopyridine HCl Tablets, USP, 200 mg under the Rugby
label, under Qualitest and TTC Trinity labels; Pyridiate
Tablets, 200 mg, under the Rugby label, for symptomatic
relief of pain burning, urgency, frequency and other
discomforts arising from irritation of the lower urinary
tract mucosa. Recall #D-311-3.
CODE Lot #D132D.
MANUFACTURER Trinity Technologies Corporation, Roseville, Michigan.
RECALLED BY Manufacturer, by telephone May 28, 1993. Firm-initiated
recall complete.
DISTRIBUTION Alabama, New York.
QUANTITY 600 1,000-tablet bottles were distributed.
REASON Short fill.
_______________
PRODUCT Prop-A-Hist Antihistamine-Decongestant Caplets, in 100
tablet bottles, for symptomatic relief of rhinitis allergic
bronchitis, bronchospasm, hay fever, common cold, sinusitis
and skin allergies. Recall #D-312-3.
CODE Lot #K116C EXP 10/96.
MANUFACTURER Trinity Technologies Corporation, Roseville, Michigan.
RECALLED BY Manufacturer, by telephone December 21, 1992. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1,000 100-tablet bottles were distributed.
REASON Stability data does not support expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
====================
_______________
PRODUCT Platelets. Recall #B-323-3.
CODE Unit #13H68539.
MANUFACTURER American Red Cross, Detroit, Michigan.
RECALLED BY Manufacturer, by telephone, followed by letter July 2, 1991.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly reactive for the
antibody to the Hepatitis C virus (anti-HCV), was
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Plasma. Recall #B-353/354-3.
CODE Unit numbers: (a) 53FC28768, 53FE08252, 53FF06185,
53FH24560, 53FH24562, 53FH24563; (b) 53FF06185.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY Manufacturer, by telephone April 7, 1993, followed by letter
8, 1993. Firm-initiated recall complete.
DISTRIBUTION Maryland, Washington, D.C., Pennsylvania.
QUANTITY (a) 6 units; (b) 1 unit.
REASON Blood products, corresponding to units of Platelets which
were implicated in a case of post-transfusion septicemia
with group B beta hemolytic Streptococcus sp., were
distributed.
_______________
PRODUCT (a) Platelets, Expired; (b) Fresh Frozen Plasma; (c)
Recovered Plasma. Recall #B-356/358-3.
CODE Unit numbers: (a) H30242/1, H31635/1; (b) H22490/2; (c)
H26903/2, H30242/2.
MANUFACTURER Milton S. Hershey Medical Center, Hershey, Pennsylvania.
RECALLED BY Manufacturer, by letter march 23, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Pennsylvania, Maryland.
QUANTITY (a) 2 units; (b) 1 unit; (c) 2 units.
REASON Blood products which tested non-reactive for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1), but,
were collected from a donor who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
===================
_______________
PRODUCT (a) Platelets for Further Manufacture; (b) Recovered Plasma.
Recall #B-351/352-3.
CODE Unit #60J27880.
MANUFACTURER American Red Cross Blood Services, Miami, Florida.
RECALLED BY Manufacturer, by telephone and by fax August 6, 1992. Firm-
initiated recall complete.
DISTRIBUTION Florida, California.
QUANTITY 1 unit of each component.
REASON Blood products, corresponding to a unit of Red Blood Cells
found to be contaminated with Serratia liquefaciens were
distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-355-3.
CODE 53FC28768, 53FE08252, 53FH24560, 53FG24562, 53FH24563.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY Manufacturer, by telephone April 7, 1993, followed by letter
8, 1993. Firm-initiated recall ongoing.
DISTRIBUTION California.
QUANTITY 5 units.
REASON Blood products, corresponding to units of Platelets which
were implicated in a case of post-transfusion septicemia
with group B beta hemolytic Streptococcus sp., were
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
======================
_______________
PRODUCT Amsco Quantum 3080RC and 3080RL Surgical Tables.
Recall #Z-642/643-3.
CODE Tables manufactured during the period of July 21, 1988
through February 17, 1993, distributed during the period of
October 1988 through March 1993. Serial numbers beginning
04-20388-P01 through B4-04893-050.
MANUFACTURER American Sterilizer Company, Montgomery, Alabama.
RECALLED BY Amsco International, Inc., Pittsburgh, Pennsylvania, by
letter July 9, 1993. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 4,265 tables subject to field correction.
REASON Unanticipated movement of the surgical tables due to loss of
hydraulic pressure in the side tilt hydraulic cylinder.
_______________
PRODUCT Lifestyles Latex Condoms: (a) Extra Strength with
Nonoxynol-9, 3 pack; (b) Spermicidally Lubricated with
Nonoxynol-9, 3 pack. Recall #-Z-664/665-3.
CODE Lot numbers: (a) 108060100, 109050700; (b) 108066800,
205038300.
MANUFACTURER Ansell, Inc., Dothan, Alabama.
RECALLED BY Manufacturer, by telephone August 17, 1992, followed by
letter August 20, 1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates none remains on the market.
REASON Devices failed to pass FDA testing for leakage.
_______________
PRODUCT Medtronic 14K Percutaneous Transluminal Coronary Artery
Catheter. Recall #Z-668-3.
CODE Model 14K2040, Lot numbers: 30305C2, 30312E2, 3031B52,
30401A2.
MANUFACTURER Medtronic Interventional Vascular, Inc., San Diego,
California.
RECALLED BY Manufacturer, by letter dated May 11, 1993. Firm-initiated
field correction complete.
DISTRIBUTION Arizona, California, Florida, Illinois, Indiana, Kansas,
Kentucky, Louisiana, Massachusetts, Missouri, Nevada,
Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington
state, West Virginia.
QUANTITY All product has been relabeled and corrected.
REASON The rated burst pressure of 8 atmospheres was erroneously
printed on the retail shelf box. The correct rated pressure
should be labeled as 6 atmospheres.
_______________
PRODUCT EDEC 80 X-Ray Systems. Recall #Z-669-3.
CODE Undetermined.
MANUFACTURER Electromed International U.S.A., Inc., Eastlake, Ohio.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan June 18, 1993. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 143 units were distributed.
REASON The manufacturer failed to provide information and/or
complete accuracy specifications to assemblers and users.
In addition, the manufacturer failed to provide adequate
test instructions to assemblers to asure that the entrance
exposure rate (EER) limits would be met.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
=====================
_______________
PRODUCT Deknatel Teflon Pledget, product #X-4832, a pre-cut soft,
white teflon pad with dimensions of 3/8" x 3/8" x 1/16",
providing suture support and protection of tissue during
cardiovascular surgery. Recall #Z-651-3.
CODE Lot #02894.
MANUFACTURER Deknatel, Inc., Fall River, Massachusetts.
RECALLED BY Manufacturer, by telephone and by letter dated January 29,
1993. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 72 pouches were distributed; firm estimates none remains on
the market.
REASON Incorrect labeling of the primary package, which identified
the pledget sizes 3/8" x 3/16". The pledget dimensions
should read 3/8" x 3/8" x 1/16".
_______________
PRODUCT Action 3 Software, version 3.0, dated 10/15/93 for use in
the Actillume digital computer based monitoring system.
Recall #Z-685-3.
CODE Version 3.0 software.
MANUFACTURER Ambulatory Monitoring, Inc., Ardsley, New York.
RECALLED BY Manufacturer, by letter March 23, 1993. Firm-initiated
field correction ongoing.
DISTRIBUTION Mississippy, New York, California, Massachusetts, Oregon,
Texas, Florida, Georgia, Maine, Maryland, New Mexico, Rhode
Island, Illinois, Minnesota, Norway, Sweden, Canada.
QUANTITY 24 units.
REASON Storage of the data is on an incorrect channel.
MEDICAL DEVICE SAFETY ALERTS
=============================================
_______________
PRODUCT Ambulator, Model A-500 Series, a walker with a seat and
wheels used for individuals who can walk unattended but lack
the endurance to walk. Safety Alert #N-054-3.
CODE None.
MANUFACTURER Anthros Medical Group, Highland, Kansas.
ALERTED BY Manufacturer, by letter April 26, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Minnesota, Pennsylvania, New Jersey, California, Wisconsin,
New York, North Dakota, Kansas.
QUANTITY 165 ambulators of the old design were distributed.
REASON Tipping can occur if not used on a level surface.
_______________
PRODUCT Nellcor N-6000 Ultra-Cap Pulse Oximeter and Capnograph, used
to measure carbon dioxide, oxygen levels, respiratory rate,
and pulse rate. Safety Alert #N-057-3.
CODE All serial numbers.
MANUFACTURER Pryon Corporation, Menomonee Falls, Wisconsin.
ALERTED BY Manufacturer, by letter April 15, 1993.
DISTRIBUTION Nationwide and international.
QUANTITY 437 units were distributed.
REASON Electromagnetic interference (62.5 kHz) from the power
supply of the subject device can cause artifacts and false
readings on certain thoracic impedance pneumography (TIP)
respiratory monitors operating at or near the same
frequency.
MASS SEIZURES:
============================================================
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PRODUCT Prescription and over-the-counter drugs (93-707-651).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the articles' manufacture, processing,
packing, and holding do not conform to and are not operated
and administered in conformity with current good
manufacturing practice requirements.
FIRM Ambix Laboratories, East Rutherford, New Jersey.
FILED July 28, 1993; U.S. District Court for the District
of New Jersey; Civil #93-3340(HLS); FDC #66733.
SEIZED July 29, 1993 - goods valued at approximately $750,000.
_______________
PRODUCT Prescription and over-the-counter drugs (93-661-983).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the articles' manufacture, processing,
packing, and holding do not conform to and are not operated
and administered in conformity with current good
manufacturing practice requirements.
FIRM Pennex Pharmaceuticals, Inc., Morton Grove, Illinois.
FILED July 23, 1993 - Complaint for Forfeiture and Consent Order;
U.S. District Court for the Northern District of Illinois,
Eastern Division; Civ. #93C 4447; FDC #66747.
INJUNCTIONS:
==============================================================
_______________
PRODUCT Trail mix, nut mixes, nuts, seeds (93-669-454).
AGAINST Premier Packing Company, a corporation, and Eugene Cohen,
an individual, Spokane, Washington.
CHARGE The defendants adulterated the food they manufactured in
that it was prepared, packed, or held under insanitary
conditions whereby it may have and did become contaminated
with filth.
FILED July 7, 1993 - Complaint; July 14, 1993 - Consent Decree of
Permanent Injunction; U.S. District Court for the Eastern
District of Washington; Civ. #CS-93-0246-FVS; INJ 1319.
_______________
PRODUCT Ultra-Bright Light Systems (92-587-760).
AGAINST Medic-Light, Inc., a corporation, and Philip C. Hughes, an
individual, Lake Hopatcong, New Jersey.
-8- CHARGES The defendants promoted the Ultra-Bright Light Systems,
through literature and advertisements, as effective for
improving body functioning by minimizing the effects of
"daylight deprivation." The defendants adulterated the
device by not obtaining the required approved premarket
approval application for this class III medical device. The
defendants misbranded the device in that the device was
manufactured in an establishment which lacked the required
registration, the defendants failed to list the device and
failed to notify FDA at least ninety days prior to
introducing the device into interstate commerce as required.
FILED July 7, 1993 - Complaint for Injunction, Consent Decree of
Permanent Injunction; U.S. District Court for the District
of New Jersey; Civ. #93-2906(MTB); INJ 1308.
-9-
END OF ENFORCEMENT REPORT FOR AUGUST 11, 1993. BLANK PAGES MAY
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