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.
Enforcement
07/23/1991
Enforcement Report for week of July 24, 1991
July 24, 1991
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
Product: Earthenware dinner platters:
(a) Round Deep Platter;
(b) Octagonal Platter;
(c) Round, Shallow Platter (Blue Rim);
(d) Round, Shallow Platter (Green Rim).
Recall #F-486/489-1.
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Code: (a) Style #91011;
(b) Style #91014;
(c) Style #91012;
(d) Style #91013.
Manufacturer: I.M.A. Ceramiche Artistiche, Italy.
Recalled by: Macy's California Inc., San Francisco, California, by
removing platters from retail shelves on November 19, 1990
and by placing signs in retail stores on February 1, 1991
instructing consumers to return the round deep platter and
the octagonal platter. Firm-initiated recall ongoing.
Distribution: California.
Quantity: 22 platters were distributed.
Reason: Products contains excessive leachable lead.
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Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Mountain water in 16 ounce containers:
(a) Sunrise Mountain Water; (b) Greene Mountain Spring
Water. Recall #F-484/485-1.
Code: (a) EXP date of AUG 27; (b) EXP dates of MAY 19,
JUNE 24 and AUG 27.
Manufacturer: Arcadia Dairy Farms, Inc., Arden, North Carolina.
Recalled by: Manufacturer, by telephone in late April 1991.
Firm-initiated recall ongoing.
Distribution: (a) South Carolina, Alabama, North Carolina, Tennessee;
(b) Tennessee.
Quantity: (a) 275 cases (25 containers/case); (b) 843 cases
(25 containers/case) were distributed; firm estimates
none remains on the market.
Reason: Product contains yeast.
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Product: Vitamin B-1 Tablets, 100 mg, in 100 tablet bottles.
Recall #F-490-1.
Code: Lot #87A91219 EXP 11/92.
Manufacturer: Nutro Laboratories, Inc., South Plainfield, New Jersey.
Recalled by: Goldline Laboratories, Fort Lauderdale, Florida, by
telephone May 10, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 5,000 bottles were distributed; firm estimates none
remains on the market.
Reason: Vitamin B-6 Tablets mixed in with Thiamine (Vitamin
B-1) Tablets.
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Medihaler Ergotamine with Oral Adapter (aerosol drug
dispenser for migraine headaches), ergotamine tartrate
9.0 mg/ml in a dispenser holding 2.5 ml. Recall #D-494-1.
Code: Lot 901346.
Manufacturer: 3M Pharmaceuticals, Northridge, California.
Recalled by: 3M Pharmaceuticals (formerly 3M Riker), St. Paul, Minnesota,
by letter June 21, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and Australia.
Quantity: 24,060 vials were distributed.
Reason: Increased frequency of adverse reactions.
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Product: (a) Extendryl Jr. Capsules T.D., and in 100-capsule and
1,000-capsule bottles;
(b) Extendryl Sr. Capsules, in 100-capsule and 1,000-
capsule bottles, an Rx antihistaminic-decongestant.
Recall #D-496/497-1.
Code: All lots.
Manufacturer: Fleming & Company, Fenton, Missouri (repacker/responsible
firm).
Recalled by: Manufacturer, by letter June 5, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: (a) 37,994,000 capsules; (b) 48,086,000 capsules were
distributed; firm estimates 4,000 bottles (both sizes and
strengths) remain on the market.
Reason: Products do not meet potency specifications.
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Product: S.P.T. Thyroid Capsules (a) 1 gr; (b) 2 gr; (c) 3 gr;
(d) 5 gr strengths, packaged in bottles containing 100
and 1,000 gel-caps, 12 or 24 bottles per case, an
Rx product. Recall #D-498/501-1.
Code: All lots.
Manufacturer: Fleming & Company, Inc., Fenton, Missouri (repacker/
responsible firm).
Recalled by: Manufacturer, by letter June 5, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
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Quantity: (a) 1,948,414; (b) 1,435,981; (c) 1,587,586; (d) 450,700
capsules were distributed; firm estimates 300 bottles
remain on the market.
Reason: Products do not meet potency specifications.
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Product: Mebaral, Mephobarbital Tablets, USP, 100 mg (1 1/2 grains),
in 250-tablet bottles, an Rx drug used as an anticonvulsant
in the treatment of chronic epilepsy. Recall #D-502-1.
Code: Lot numbers 615BE, 649BK, 641CE, 610CN, 655DC, 610BH,
688CC, 652CH, 638DA, 649DD.
Manufacturer: Winthrop Pharmaceuticals, Renssaler, New York.
Recalled by: Sterling Drug, Inc., New York, New York, by letter
April 29, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 3,456 units (615BE), 5,772 units (649BK), 8,640 units
(641CE), 8,580 units (610CN), 8,196 units (652CH),
8,117 units (688CC), 8,556 units (655DC), 8,023 units
(638DA), 8,052 units (649DD) were distributed; firm
estimates very few of the bottles remain on the market.
Reason: Product fails dissolution specifications.
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Product: Rugby brand Amitriptyline HCl Tablets, 75 mg, in
100 and 500-tablet bottles, an Rx antidepressant.
Recall #D-505-1.
Code: Lot numbers: 008NC052, 010NC055, 011NC015, 011NC016,
011NC020, 011NC039, 012NC040.
Manufacturer: Chelsea Laboratories, Inc., Monroe, North Carolina.
Recalled by: Manufacturer, by letter May 16, 1991. Firm-initiated
recall ongoing.
Distribution: Unknown.
Quantity: 19,822 bottles of 100 and 2,015 bottles of 500
were distributed.
Reason: Incorrect quantities of two inactive ingredients.
----
Product: Barr Laboratories brand Ibuprofen Tablets, 200 mg,
oral OTC analgesic, packaged in bulk only, repackaged
under the following labels: Safeway, Pharmacist formula
label, and Vitafresh. Recall #D-506-1.
Code: Lot #1BD0154.
Manufacturer: Barr Laboratories, Northvale, New Jersey.
Recalled by: Barr Laboratories, Inc., Pomona, New York, by
telephone June 4, 1991, followed by letter
June 4 and 5, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 4,844,082 tablets were distributed.
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Reason: A bottle of Ibuprofen tablets contained a foreign
tablet identified as a Barr furosemide 40 mg tablet.
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Product: Prochlorperazine Maleate Tablets, USP, 5 mg, unit
dose packaged 10 tablets per card, 10 cards per
box, an Rx oral medication for the treatment of severe
nausea and vomiting, and manifestations of psychotic
disorders. Recall #D-507-1.
Code: Item 71905, Lot #0P047 EXP 4/92, #OS130 EXP 9/92.
Manufacturer: Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by: UDL Laboratories, Inc., Rockford, Illinois, by letter
June 25, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 8,508 unit dose cartons were distributed; firm estimates
35 percent remains on the market.
Reason: Lack of assurance of bioequivalency.
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Product: Platelets, Pheresis. Recall #B-254-1.
Code: Unit numbers: 3308952, 3308953, 3308954.
Manufacturer: Central Indiana Regional Blood Center, Inc., Indianapolis,
Indiana.
Recalled by: Consignee discovered labeling error March 14, 1991, and
returned two units to manufacturer for relabeling. One
unit was corrected by manufacturer. Recall complete.
Distribution: Indiana.
Quantity: 3 units.
Reason: Blood products labeled with incorrect expiration dates
were distributed.
----
Product: Recovered Plasma. Recall #B-307-1.
Code: Unit #26630.
Manufacturer: LaGuardia Hospital, Forrest Hills, New York.
Recalled by: Manufacturer, by telephone and by letter
November 14, 1990. Firm-initiated recall ongoing.
Distribution: New York.
Quantity: 1 unit.
Reason: Blood product that tested repeatably reactive for
hepatitis B surface antigen (HBsAg) was distributed.
----
Product: Recovered Plasma. Recall #B-348-1.
Code: Unit numbers: 90-09813, 90-09962, 90-10419, 90-10635,
90-10639, 91-11995.
Manufacturer: St. Luke's Hospital of New Bedford, Inc.,
New Bedford, Massachusetts.
-5-
Recalled by: Manufacturer, by telephone and letter May 30, 1991.
Firm-initiated recall ongoing.
Distribution: Pennsylvania, Massachusetts.
Quantity: 6 units.
Reason: Blood products that tested repeatably reactive for
hepatitis B surface antigen (HBsAg) were distributed.
----
Class III -
Product: Senokot Syrup (standardized extract of Senna Fruit), in
8 ounce bottles, an oral OTC syrup indicated for relief
of constipation. Recall #495-1.
Code: Lot #OAV.
Manufacturer: P.F. Laboratories, Inc., Totowa, New Jersey.
Recalled by: The Purdue Frederick Company, Norwalk, Connecticut,
by letter June 7, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 4,500 bottles were distributed.
Reason: Labels on some bottles do not remain affixed to the bottle.
----
Product: OTC Neo-Synephrine, mild formula, 1/4% Nasal Decongestant
Spray, 1/2 fluid ounces (15 ml), intranasal administration,
1/2 fluid ounce white plastic bottle, used as a
decongestant for the relief of nasal congestion and upper
respiratory allergies. Recall #D-503-1.
Code: Lot #B325fl.
Manufacturer: Glenbrook Laboratories, Division of Sterling Drug Inc.,
Sterling Pharmaceuticals Inc., Barcelonetta, Puerto Rico.
Recalled by: Sterling Drug, New York, New York, by letter May 17, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates 43,000 units were distributed.
Reason: Product discoloration.
----
Product: Fisons brand Intal Nebulizer Solution (cromolyn sodium
inhalation (USP), 2 ml ampules, for inhalation use only,
in boxes of 60 and 120, used in the management of patients
with bronchial asthma. Recall #D-504-1.
Code: Lot numbers: HN4064B EXP 1/95, HN4065B EXP 1/95,
HN4066B EXP 1/95, HN4068B EXP 1/95, HN4072B EXP 1/95,
through HN4081B EXP 1/95, HN4085B EXP 2/95,
HN4086B EXP 2/95, HN4087B EXP 2/95, HN4090B EXP 2/95,
HN4091B EXP 2/95.
Manufacturer: Laboratories Fisons SA, LeTrait, France.
Recalled by: Fisons Corporation, Rochester, New York, by letter
June 25, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
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Quantity: 32,268 boxes of 60 ampules and 6,232 boxes of 120
ampules were distributed.
Reason: Unauthorized modification of the synthesis process of the
raw material used to produce active ingredient.
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Product: (a) Red Blood Cells; (b) Platelets, Pheresis.
Recall #B-255/256-1.
Code: Unit numbers: (a) 11F61210; (b) 11FG10027.
Manufacturer: American Red Cross Blood Services, St. Louis, Missouri.
Recalled by: Manufacturer, by telephone August 24, 1990.
Firm-initiated recall complete.
Distribution: Missouri.
Quantity: 1 unit of each component.
Reason: Blood products, which were improperly tested for
antibody to the human T-lymphotropic virus type I
(anti-HTLV-1), were distributed for transfusion.
----
Product: Plasma. Recall #B-285-1.
Code: Unit numbers: LR16375 and LR16421.
Manufacturer: St. Anthony's Hospital, Inc., Leon E. Reilly Memorial
Blood Bank, St. Petersburg, Florida.
Recalled by: Consignee notified firm of labeling error by
telephone March 9, 1990. Confirmation letter sent
November 9, 1990. Recall complete.
Distribution: Virginia.
Reason: Blood products labeled with incorrect expiration dates
were distributed.
----
Product: Red Blood Cells. Recall #B-295-1.
Code: 53L00979.
Manufacturer: American Red Cross, Greater Chesapeake and Potomac
Region, Baltimore, Maryland.
Recalled by: Manufacturer, by telephone October 5, 1990, and
by letter February 5, 1991. Firm-initiated recall
complete.
Distribution: Maryland.
Quantity: 1 unit.
Reason: Blood product collected from a donor who previously
tested repeatably reactive to the human immuno-
deficiency virus type 1 (anti-HIV-1), was distributed.
----
Product: Red Blood Cells. Recall #B-346-1.
Code: Unit #41LX09786.
Manufacturer: American Red Cross Blood Services, Montgomery, Alabama.
-7-
Recalled by: Consignee returned product to firm for relabeling
September 25, 1990. Recall complete.
Distribution: Alabama.
Quantity: 1 unit.
Reason: Blood product labeled with incorrect expiration date
was distributed.
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DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: ACS Coronary Infusion catheters, flexible plastic devices
used for the infusion of solutions into the coronary
arteries:
(a) Coronary Infusion Catheter Kit (without side holes),
Catalog #16004;
(b) Coronary Infusion Catheter (with side holes),
Catalog #16005.
Recall #Z-763/764-1.
Code: All lot numbers.
Manufacturer: Advanced Cardiovascular Systems, Inc., Temecula, California.
Recalled by: Manufacturer, by letters of December 22, 1989 and
January 17, 1990. Firm-initiated recall complete.
Distribution: Nationwide and international.
Quantity: Firm estimates none remains on the market.
Reason: Over an extended period of time, these catheters may
become brittle and fracture.
----
Product: 7-AT Aerosol Treatment and Sputum Induction Chamber,
for the administration of aerosol drugs and
induction of patient sputum from tuberculosis and AIDS
patients. Recall #Z-827-1.
Code: Serial numbers 9001-9051 and 9101-9111.
Manufacturer: J.H. Emerson, Cambridge, Massachusetts.
Recalled by: Manufacturer, by letter April 19, 1991. Firm-initiated
field correction ongoing.
Distribution: Nationwide.
Quantity: 62 units were distributed.
Reason: The device may leak contaminated air.
----
Product: Ambulance Cots, Model 29M. Recall #Z-829-1.
Code: Serial numbers ranging from L-81569 to L-130048.
Manufacturer: Ferno Washington, Wilmington, Ohio.
-8-
Recalled by: Manufacturer, by letter May 2, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 1,800 units were distributed.
Reason: The plunger pin assembiles in this product could
malfunction.
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Product: "Hi-Torque Standard" Coronary Dilatation Catheter
Guidewire, 0.018, a steerable guidewire with a
shapable radiopaque tip. Recall #Z-833-1.
Code: Catalog #22218M, lot #0020851.
Manufacturer: Advanced Cardiovascular Systems, Inc., Temecula,
California.
Recalled by: Manufacturer, by letter March 27, 1990. Firm-initiated
recall complete.
Distribution: Ohio, Florida, Illinois, Pennsylvania, Alaska, Missouri,
New York, Norway, Japan.
Quantity: 125 units were distributed; firm estimates none remains
on the market.
Reason: Possible mislabeling on the inner pouch of the product.
Some products have been labeled as Catalog #22318M-014
Hi-Torque Standard Guidewire on the inner pouch.
----
Product: Infant Warming Systems (a) Model 3300; (b) Model 5000.
Recall #Z-838/839-1.
Code: AANT00596 through 01009 and AANU00001 through 00170.
Manufacturer: Ohmeda Critical Care-Maryland, Division of BOC Health
Care, Columbia, Maryland.
Recalled by: Manufacturer, by letter April 24, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 583 units were distributed.
Reason: The hydraulic tilt mechanism may malfunction and cause
the bed to move slowly from the horizontal or selected
tilt position to the maximum tilt position of 10 degrees
without user activation of the tilt mechanism. Defect
may cause patient injury as result of a fall.
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NOTE: Recall numbers Z-763/764-1, Fetal Bovine Serum, which
appeared originally in the June 19, 1991 and corrected in
the July 17, 1991 Enforcement report has been recinded.
It has been determined that the product was illegally
imported only under USDA import regulations. The product
does not violate FDA regulations, and is therefore being
reclassified as a market withdrawal. The above numbers
have been reassigned.
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Class III -
Product: Temperature Probe, Esophageal/Rectal, #9 FR, a sterile
single-use Rx device, packaged 50 units per case.
Recall #Z-828-1.
Code: Catalog #2403, lot #M391910.
Manufacturer: Electromedics, Inc., Englewood, Colorado.
Recalled by: Manufacturer, by letter May 31, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, New Zealand, England.
Quantity: 4,000 units were distributed.
Reason: Product description is incorrect.
----
Product: Hi-Torque Floppy Guidewire, .010, with Microglide
Coating, a steerable guidewire with a shapable, radiopaque
tip. Recall #Z-846-1.
Code: Catalog #25002M-010, lot #1010752.
Manufacturer: Advance Cardiovascular Systems, Inc., Temecula,
California.
Recalled by: Manufacturer, by voice mail March 5, 1991 and
by FAX March 4, 1991. Firm-initiated recall complete.
Distribution: Nationwide, Australia, England, Spain.
Quantity: 33 5 packs were distributed; firm estimates none
remains on the market.
Reason: The outer five-pack box is mislabeled as containing an
"Extendable" guidewire.
----
Product: Hi-Torque Floppy II Guidewire with Pre-Shaped Tip,
a steerable guidewire with a radiopaque, shapable
distal tip. Recall #Z-847-1.
Code: Catalog #22339MJ-903, lot #1020751.
Manufacturer: Advanced Cardiovascular Systems, Inc., Temecula, California.
Recalled by: Manufacturer, by telephone March 8, 1991. Firm-initiated
recall complete.
Distribution: Ohio, Minnesota.
Quantity: 9 5-pack boxes were distributed; firm estimates
none remains on the market.
Reason: The letter "J", which signifies the wire is pre-shaped,
was left off the catalog number on the box label only.
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VETERINARY PRODUCTS
NONE
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Medical Device Safety Alerts:
Product: Symbios Universal A-V Telemetric Pacemakers, dual-
chamber implantable pulse generators:
(a) Model 7005; (b) Model 7005C; (c) Model 7006;
(d) Model 7008. Safety Alert #M-029/032-1.
Code: All serial numbers.
Manufacturer: Medtronic, Inc., Minneapolis, Minnesota;
Med Rel, Inc., Humacao, Puerto Rico.
Alerted by: Medtronic, Inc., Minneapolis, Minnesota, by letter
dated June 14, 1991.
Distribution: Nationwide and international.
Quantity: 18,335 units.
Reason: A performance anomaly occurs that involves the potential for
permanent loss of the ability to interrogate the
pacemaker or receive programming confirmation, and a
subsequent temporary loss of output.
----
Seizure Actions Filed:
Product: Communidyne Computerized Hearing Test Machine (81-577-369).
Charge: Misbranded - Firm failed to submit premarket notification.
Also labeling of article fails to provide adequate
directions for use for purposes for which the device
is intended. Labeling is false and misleading
because it represents and suggests that the device is
effective in diagnosing loss of hearing.
Firm: Communidyne Inc., Northbrook, Illinois.
Filed: July 9, 1991 - U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #91C4239,
FDC #66184.
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