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
10/07/1992
RECALLS AND FIELD CORRECTIONS: October 7, 1992
FOODS -- CLASS I
92-41
PRODUCT Royal Baltic brand: (a) Vacuum Packed Smoked Shad, packed
either whole or in slices in clear plastic packages with gold,
black and red paper stick-on label on each package. Whole fish
weighs between 1 and 2 pounds;
(b) Air Packed Shad, packed loose in cardboard boxes with gold,
black and red paper stick-on label affixed to box.
Recall #F-568/569-2.
CODE 211-CJ through 218-CJ appearing on the plastic package or the
cardboard box.
MANUFACTURER Royal Baltic Ltd., Brooklyn, New York.
RECALLED BY Manufacturer, by telephone and by letter September 4, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY Approximately 200 pounds were distributed.
REASON The product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT Canned beans: (a) Campbell Soup brand Hot Chili Beans, in
15-1/2 ounce cans; (b) Ranchero Beans, in 7-3/4 ounce, 15-1/2
ounce and 21 ounce cans. Recall #F-566/567-2.
CODE All lots.
MANUFACTURER Campbell Soup Company, Paris, Texas.
RECALLED BY Campbell Soup Company, Camden, New Jersey, by letter August 31,
1992. Firm-initiated recall complete.
DISTRIBUTION West, southwest, and southeast areas of the United States.
QUANTITY 21,321 cases were distributed.
REASON Product is contaminated with sharp seed pods (sandburrs).
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT Montco brand Sauerkraut, in 8 ounce and 16 ounce cans.
Recall #F-482-2.
CODE All lots with the Montco label.
MANUFACTURER Fleming Foods, Inc., Oklahoma City, Oklahoma (distributor).
RECALLED BY Distributor, by letter July 31, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Delaware, Maryland, New Jersey, Pennsylvania.
QUANTITY Firm estimates that little product remains on the market.
REASON Product is mislabeled as to sodium content.
PRODUCT Kings Pantry brand Pieces and Stems Canned Mushrooms, in 4
ounce cans. Recall F-546-2.
CODE NL 299 1 155 VPS 110, NL 306 1 115 VPS 110, NL 87 2 115 VPS 23.
MANUFACTURER Vervuurt, Horst, Holland (packer).
RECALLED BY C.M.G. Trading, Inc., Short Hills, New Jersey, by letter July
7, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Michigan, New York, Florida.
QUANTITY 3,100 cases (24 cans per case) were distributed.
REASON Containers do not bear an identifying code as required by
regulation.
PRODUCT Mushrooms, stems and pieces, in 68 ounce cans, product of Hong
Kong. Recall #F-565-2.
CODE MPS/CS/2411, MPS/CS/2320, MPS/CS/2429, MPS/CS/2629.
MANUFACTURER Ho Tung Lau Koo Tung Village, Kowloon, Hong Kong.
RECALLED BY Sandler Foods, Virginia Beach, Virginia, by letters distributed
to customers by September 10, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,029 cases were distributed.
REASON Product is contaminated with filth.
-2-
RECALLS AND FIELD CORRECTION: DRUGS -- CLASS II
PRODUCT Chlordiazepoxide HCl Capsules, USP: (a) 10 mg; (b) 25 mg, in
bottles of 100, 500, and 1,000, a Rx drug with anti-anxiety and
sedative actions, under the Pioneer and URL labels.
Recall #D-520/521-2.
CODE Lot numbers and EXP dates: (a) 4011-13 6/92, 4011-14 EXP 11/92,
4011-15 EXP 2/93, 4011-18 EXP 10/93, 4011-19 EXP 11/93,
4011-20 EXP 11/93; (b) 4012-7 9/92, 4012-7A 9/92.
MANUFACTURER Pioneer Pharmaceuticals, Inc., Irvington, New Jersey.
RECALLED BY Manufacturer, by letters of March 27, 1992 and April 13,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Indiana, Maryland, Michigan, Pennsylvania.
QUANTITY Firm estimates (a) 3,037,000 capsules; (b) 453,000 capsules
remain on the market.
REASON Use of unapproved manufacturing procedures.
PRODUCT Indomethacin Capsules, in bottles of 100 and 500, Rx
non-sterodial anti-inflammatory, antipyretic and analgesic,
under the Pioneer, Major and URL labels: (a) 25 mg;
(b) 50 mg. Recall #D-522/523-2.
CODE Lots numbered consecutively (a) 4005-8 through 4005-19;
(b) 4006-9 through 4006-15.
MANUFACTURER Pioneer Pharmaceuticals, Inc., Irvington, New Jersey.
RECALLED BY Manufacturer, by fax April 9, 1992, and by letter April 13,
1992. Firm-initiated recall ongoing.
DISTRIBUTION California, Florida, Illinois, Indiana, Kentucky, Maryland,
Michigan, New York, Pennsylvania.
QUANTITY Firm estimates (a) 2,700,000 capsules; (b) 1,580,000 capsules
remain on the market.
REASON Use of unapproved manufacturing procedure.
PRODUCT Resporal TR Tablets, in bottles of 50, 100 and 1,000, a Rx drug
under Pioneer, Goldline and Rugby labels. Recall #D-524-2.
CODE Lot numbers and EXP dates: 3003-36 12/92, 3003-41 12/92,
3003-45 9/92, 3003-47 11/92, 3003-48 12/92, 3003-52 3/95,
3003-53 3/95, 3003-54 7/95.
MANUFACTURER Pioneer Pharmaceuticals, Irvington, New Jersey.
RECALLED BY Manufacturer, by fax May 6, 1992 and by letter May 8, 1992.
Firm-initiated recall ongoing
DISTRIBUTION Florida, Iowa, Maryland, New Jersey, New York.
QUANTITY Firm estimates 3,465,000 tablets remain on the market.
REASON Use of unapproved manufacturing procedures.
PRODUCT Diphenhydramine HCl Capsules, (a) 25 mg; (b) 50 mg, packaged in
bottles of 100, 500, and 1000, a Rx antihistamine, under the
Pioneer, Goldline, Rugby, and Bioline labels.
Recall #D-005/006-3.
-3-
CODE Lot numbers and EXP dates: (a) 4103-35 5/92, 4013-36 6/92,
4013-37 6/92, 4013-38 7/92, 4013-39 8/92, 4013-40 8/92, 4013-41
8/92, 4013-42 10/92, 4013-43 10/92 4013-44 12/92, 4013-45 1/93;
(b) 4008-39 6/92, 4008-40 6/92, 4008-41 7/92, 4008-42 8/92,
4008-43 8/92, 4008-44 9/92, 4008-45 12/93.
MANUFACTURER Pioneer Pharmaceuticals, Irvington, New Jersey.
RECALLED BY Manufacturer, by telephone May 5, 1992, by fax May 6, 1992, and
by letter May 8, 1992. Firm-initiated recall ongoing.
DISTRIBUTION (a) Florida, Indiana, Tennessee, Puerto Rico; (b) Florida,
Tennessee, Puerto Rico.
QUANTITY Firm estimates (a) 5,418,000 capsules; (b) 2,656,000 capsules
remain on the market.
REASON Use of unapproved manufacturing procedures.
PRODUCT (a) Beclovent Beconase (Beclomethasone Dipropionate, USP)
Inhalation Aerosol Refill, 16.8 grams, 200 metered inhalations,
for use with either the Beclovent Oral Adapter or the Beconase
Nasal Adapter;
(b) Beclovent (Beclomethasone Dipropionate, USP) Inhalation
Aerosol, 6.7 grams, 80 metered inhalations, for oral inhalation
with the beclovent inhalation aerosol adapter;
(c) Beclovent (Beclomethasone Dipropionate, USP) Inhalation
Aerosol, 6.7 grams, 80 metered inhalations, for oral inhalation
with the beclovent inhalation aerosol adapter. This 6.7 gram
Beclovent is a professional sample, not for sale.
Recall #D-009/010-3.
CODE: Lot numbers: (a) Z8262DA and Z8272DA EXP May 1994;
(b) Z4932BA EXP MAY 1994; (c) Z5072BA, Z5082BA AND Z8432DA EXP
JUNE 1994.
MANUFACTURER Glaxo, Inc., Zebulon, North Carolina.
RECALLED BY Manufacturer, by electronic mail September 1, 1992, and by
letters of September 15 and 17, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 61,793 cans were distributed.
REASON Subpotency.
UPDATE Adenocard (adenosine) 3 mg/ml, Recall #D-398-2, manufactured by
Lyphomed, Division of Fujisawa USA, Inc., which appeared in the
June 24, 1992 Enforcement Report has been extended to include
lot numbers 320340 and 320460.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Full Value and Health Mart brands of Isopropyl Rubbing Alcohol,
70%, 16 fluid ounces. Recall #D-001-3.
CODE Lot numbers: 126011 and 220631.
MANUFACTURER Cumberland-Swan, Inc., Smyrna, Tennessee.
-4-
RECALLED BY Manufacturer, by telephone August 26, 1992, by electronic mail
August 28, 1992, and by letter September 1, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Arkansas, Colorado, Florida, Illinois, Louisiana, Missouri,
Ohio, Oklahoma, Texas, Wisconsin.
QUANTITY 4,804 cases of lot 216001 and 295 cases of lot 220631,
12 bottles per case were distributed.
REASON Label fails to bear indications, ingredients and caution
statements.
PRODUCT Norwich Aspirin, 325 mg, 100 coated tablets in plastic bottle.
Recall #D-002-3.
CODE Lot #206777 EXP APR 97.
MANUFACTURER Procter & Gamble Pharmaceuticals, Inc., Norwich, New York.
RECALLED BY Chattem, Inc., Chattanooga, Tennessee, by letter September 22,
1992, to be followed by visit or telephone. Firm-initiated
recall ongoing.
DISTRIBUTION California, Colorado, Connecticut, Florida, Georgia, Minnesota,
New Jersey, New York, North Carolina, North Dakota, Ohio,
Oklahoma, Pennsylvania, Texas, Virginia, Washington state, West
Virginia, Indiana, Kentucky, Massachusetts.
QUANTITY Approximately 1,400 dozen bottles were distributed beginning on
8/26/92.
REASON Incorrect wording in caution statement.
PRODUCT (a) MHL Decongestant Pseuodephedrine Hydrochloride Tablets, in
36 and 100 tablet bottles; (b) MHL Decongestant Plus
Pseudoephedrine HCl, 60 mg Chlorpheniramine Maleate, 4 mg, in
36 and 100 tablet bottles. Recall #D-003/004-2.
CODE (a) 8480 11 94; (b) 8510 12 94.
MANUFACTURER Magno-Humphries, Inc., Tigard, Oregon.
RECALLED BY Manufacturer, by letter April 24, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Oregon, Washington state.
QUANTITY (a) 2,096 36-count bottles and 7,930 100-count bottles; (b) 372
36-count bottles and 1,002 100-count bottles were distributed.
REASON Presence of a foreign tablet in each product, identified as
bisacodyl and biotin.
PRODUCT Brioschi for upset stomach, powder/granules packaged in 8-1/2
ounce bottles and 12 x 6 gm foil packs. Recall #D-007-3.
CODE Returned packages coded: Lot #92021 EXP 1/97, unopened cases
coded 92021.
MANUFACTURER Brioschi, Inc., Fairlawn, New Jersey.
RECALLED BY Manufacturer, by visit on or about June 23, 1992 and by fax
June 26, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
-5-
QUANTITY 8,820 (8-1/2 ounce bottles), and 1,944 (12 x 6 gm foil packs)
were distributed; firm estimates 2,600 8-1/2 ounce bottles and
200 foil packs remain on the market.
REASON Presence of trace quantities of sulfides.
PRODUCT Fentanyl Citrate, USP, 5 cc Carpuject prefilled syringe, a Rx
analgesic. Recall #D-008-3.
CODE M500JA EXP July 1993.
MANUFACTURER Sanofi Winthrop Pharmaceuticals, McPherson, Kansas.
RECALLED BY Sterling Winthrop, New York, New York, by letter dated
September 8, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,266 boxes each containing 10 syringes were distributed.
REASON Some units were found to malfunction not permitting penetration
of the rubber stopper.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT Reagent Red Blood Cells. Recall #B-447-2.
CODE Unit #101430.
MANUFACTURER Tennessee Blood Services Corporation, Memphis, Tennessee.
RECALLED BY Manufacturer, by telephone November 4, 1991. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Unit repeatably reactive for the antibody to the human
immunodeficiency virus (anti-HIV-1) was distributed for further
manufacturing.
PRODUCT (a) Red Blood Cells; (b) Red Blood Cells, Expired;
(c) Platelets; (d) Cryoprecipitated AHF;
(e) Fresh Frozen Plasma; (f) Recovered Plasma.
Recall #B-451/456-2.
CODE Unit numbers: (a) 1062661, 1068816, 1071299, 1074477, 1165307,
1366581, 1471329, 1476075, 1560489, 1658055, 1661143, 1664604,
1667029, 2461281, 5066051, 5072053, 5764322, 5771184, 5771678,
6070200, 6070802, 6071421, 6170545, 9060332, 9062558, 9161292,
9363715, 9370802, 9460968, 9464866, 9661416;
(b) 1065224, 1662128;
(c) 1062661, 1471329, 1661143, 1664604, 1667029, 1688055,
5771184, 5771678, 9062558, 9161292, 9363715;
(d) 1476075, 5072053;
(e) 1661143, 1664604, 1667029, 1071299, 1071299 (Pedi),
7760426, 7763193, 7764104, 9062558, 9161292, 9363715;
(f) 1062661, 1068816, 1074477, 1165307, 1471329, 1476075,
1560489, 1563312, 1662128, 1688055, 2461281, 5764322, 5771184,
5771678, 6070200, 6070802, 6071421, 6170545, 9060332, 9370802,
9460968, 9464866, 9661416.
MANUFACTURER Oklahoma Blood Institute, Oklahoma City, Oklahoma.
RECALLED BY Manufacturer, by letters dated between March 14, 1991, and July
8, 1992. Firm-initiated recall ongoing.
-6-
DISTRIBUTION Arkansas, Florida, New Jersey, New York, Oklahoma,
Pennsylvania, Texas.
QUANTITY (a) 31 units; (b) 2 units; (c) 11 units; (d) 2 units;
(e) 11 units; (f) 23 units.
REASON Blood products, which tested negative for the antibody to human
immunodeficiency virus type 1 (anti-HIV-1), but were collected
from donors who previously tested repeatedly reactive for
anti-HIV-1, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT Red Blood Cells. Recall #B-333-2.
CODE Unit numbers: 0448518, 0449101.
MANUFACTURER Coffee Memorial Blood Center, Amarillo, Texas.
RECALLED BY Manufacturer, by telephone December 29, 1991. Firm-initiated
recall complete.
DISTRIBUTION Indiana, Texas.
QUANTITY 2 units.
REASON Blood products labeled with incorrect expiration dates were
distributed for transfusion.
PRODUCT Source Plasma. Recall #B-448-2.
CODE Unit numbers: FO1114-094, F001301-094, F001262-094,
F001505-094.
MANUFACTURER Premier BioResources, Inc., Fort Worth, Texas.
RECALLED BY Manufacturer, by letters dated July 8 and 10, 1992.
Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 4 units.
REASON Unlicensed blood products were shipped in interstate commerce.
PRODUCT Red Blood Cells. Recall #B-449-2.
CODE Unit #1769128.
MANUFACTURER Greater New York Blood Program, New York, New York.
RECALLED BY Consignee notified firm and returned unit on or about July 11,
1991. Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit.
REASON Blood product labeled with incorrect expiration date was
distributed for transfusion.
PRODUCT Red Blood Cells. Recall #B-450-2.
CODE Unit #1125698.
MANUFACTURER Manatee Community Blood Center, Inc., Bradenton, Florida.
RECALLED BY Consignee notified firm and returned the unit as instructed on
July 30, 1991. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit.
REASON Blood product labeled with an incorrect expiration date was
distributed.
-7-
MEDICAL DEVICE MANDATORY RECALLS:
PRODUCT Life Pulse High Frequency Jet Ventilator, an infant ventilating
system used with critically ill infants suffering from hyaline
membrane disease and who are failing on conventional
ventilation. Recall #Z-1307-2.
CODE All codes.
MANUFACTURER Bunnell Inc., Salt Lake City, Utah.
RECALLED BY Manufacturer per 518(e) amended order of 9-8-92. Units are to
be retrofitted and replaced. FDA-ordered recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 267 units were distributed as of November 1991.
REASON Mandatory 518(e) recall. Among the more significant of the
numerous defects are: High intermittent pressures and high
peak pressure; pinch valve malfunctions; humidification
component failures and numerous software failures.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Hemaflex Absorbable Collagen Hemostat 5 cm x 8 cm.
Recall #Z-1308-2.
CODE Lot #19111D EXP 12/94.
MANUFACTURER Bioplex Medical, Vaals, Holland
RECALLED BY Bioplex Corporation, Montvale, New Jersey, by telephone June
26, 1992, followed by letter July 2, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Massachusetts.
QUANTITY 75 boxes (10 units per box) were distributed.
REASON The outer Tyvek pouch may not be sealed at the bottom.
PRODUCT Exactech Blood Glucose Strips, used to monitor the blood sugar
level of diabetics. Recall #Z-1310-2.
CODE All lot numbers from and including 14232 through 14394, and lot
14665.
MANUFACTURER Medisense Contract Manufacturing, Inc., United Kingdom.
RECALLED BY Medisense, Inc., Cambridge, Massachusetts, by letter April
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 325,000 packages of mixed package sizes of 25
strips, 50 strips and 100 strips were distributed.
REASON The device may provide lower than actual glucose values at low
glucose concentration levels.
PRODUCT Flo-Gard 8200 Volumetric Infusion Pump, a positive-displacement
infusion pump which uses cassette administration sets to
deliver a variety of fluids, including blood, over a wide range
of infusion rates. Recall #Z-1311-2.
CODE Product code 2M8023. All serial numbers ending in "S".
MANUFACTURER Baxter Healthcare Corporation, I.V. Systems Division, Savage,
Maryland.
-8-
RECALLED BY Baxter Healthcare Corporation, I.V. Systems Division, Round
Lake, Illinois, by letter August 17, 1992. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 76 units were distributed.
REASON A software error causes a program error to occur if a certain
sequence is used, which could lead to incorrect infusion rates
or volume to be infused to the patient.
PRODUCT Vascular Punch Blade in Tyvek Pouch, intended for use with the
Deknatel Reusable Precision Vascular Punch, for creating an
opening(s) in the wall of the aorta or other selected vessels
to prepare a site for anastomosis, as in bypass surgery.
Recall #Z-1312-2.
CODE Catalog #ARB-091, lot numbers: 01471, 01471A, 02397A, 02558P.
MANUFACTURER Goosen Enterprises, Inc., Oviedo, Florida.
RECALLED BY Deknatel, Inc., Fall River, Massachusetts, by letter June 1,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 396 pieces were distributed.
REASON 4.4 mm blades were found in pouches labeled 2.7 mm punch blades.
PRODUCT Mobile "E" Stand for N20/02 "E" Cylinders, Stock #2045, a
portable stand designed as a mounting system for supplying
oxygen (02) and nitrous oxide (N20) packaged in "E" size gas
cylinders to a N20/02 flowmeter. Recall #Z-1313-2.
CODE Serial #E-5547 to E-5571.
MANUFACTURER Porter Instrument Company, Inc., Hatfield, Pennsylvania.
RECALLED BY Manufacturer, by letter June 10, 1992. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 24 units were distributed; firm estimates no recalled product
with the defect remain on the market.
REASON A nitrous oxide yoke was fitted in a place where an oxygen yoke
should have been. This defect could result in the patient
receiving 100 percent nitrous oxide instead of a nitrous
oxide/oxygen mixture.
PRODUCT LifeStyles Nuda Plus with Spermicide Ultra-Thin Condoms,
packaged in boxes of 3, 12 and 3 shrink-wrapped boxes of 12.
Recall #Z-1314-2.
CODE Lot #6118189F2 EXP 4/93.
MANUFACTURER Ansell, Inc., Dothan, Alabama.
RECALLED BY Manufacturer, by letter June 19, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,726.88 gross were distributed.
REASON Complaints of breakage during use.
-9-
PRODUCT Endoscopic Surgical Instruments with Ratchets:
(a) Endoscopy Mayo Hegar Needle Holder, 33 cm, Straight Insert
Jaws;
(b) Endoscopy Crile-Wood Needle Holder, 33 cm, Curved Insert
Jaws;
(c) Endoscopy Allis Tissue Forceps, 33 cm;
(d) Endoscopy Babcock Tissue Forceps, 33 cm;
(e) Endoscopy Crile Grasping Forceps, 33 cm, Straight;
(f) Endoscopy Crile Grasping Forceps, 33 cm Light Curve;
(g) Endoscopy Mixter Grasping Forceps, 33 cm Strong Curve.
Recall #Z-1315/1321-2.
CODE Catalog numbers: (a) 114705; (b) 114740; (c) 114712;
(d) 114713; (e) 114730; (f) 114631l (g) 114732.
MANUFACTURER Edward Weck & Company, Research Triangle Park, North Carolina.
RECALLED BY Manufacturer, by letters of June 4, 1992 and July 6, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,657 units were distributed.
REASON Devices may experience premature breakage at the jaw or handle
joint.
RECALLS AND FIELD CORRECTION: DEVICES -- CLASS III
PRODUCT Ophthalmic Trephine Blade, Catalog #9715, used to prepare both
donor and recipient corneas for implantation. Recall #Z-1309-2.
CODE Lot #1G1471.
MANUFACTURER Edward Weck & Company, Inc., Research Triangle Park, North
Carolina.
RECALLED BY Manufacturer, by telephone April 11 and 13, 1992, followed by
letter April 14, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Colombia, South Africa.
QUANTITY 398 blades were distributed.
REASON The outside label card indicates 8.5 mm blade while the package
may contain a 7.5 mm blade.
PRODUCT "STD" Contact Lenses, all sizes and powers. Recall #Z-1327-2.
CODE Lot #1221670.
MANUFACTURER Ciba Vision Corporation, Atlanta, Georgia.
RECALLED BY Manufacturer, by letter September 6, 1991. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 1,348 lenses were distributed; firm estimates 69 units remain
on the market.
REASON Lenses do not have a minus (-) designation in front of the
dioptric power.
-10-
PRODUCT In vitro Diagnostic Kits:
(a) AFT System 1 Kit, Catalog #879020;
(b) AFT System I ASMA, Catalog #879017;
(c) Anti-Human IgG Conjugate (Fluorescein Labeled), product
code 20523. Recall #Z-1328/1330-2.
CODE Lot numbers: (a) M92018, M92016; (b) M92017; (c) 205024.
MANUFACTURER Immco Diagnostics, Buffalo, New York.
RECALLED BY Manufacturer, by letters of August 11 and 12, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Maryland, New Jersey.
QUANTITY (a) 134 kits; (b) 150 kits; (c) 2 bulk plasma packs (1805 ml
and 1802 ml) were distributed.
REASON Products were manufactured with microbially-contaminated
deionized water which could lead to erroneous testing results.
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II
PRODUCT Pig Starter: (a) #20 CSP, in 50 pound multi-layered paper
bags; (b) #10, in 50 pound multi-layered paper bags, a
medicated feed for reduction of incidence of cervical abcesses
and treatment of bacterial swine enteritis.
Recall #V-051/052-2.
CODE Lot numbers: (a) FJ852, FJ1662, FJ2192, GJ562, GJ1642, HJ72;
(b) FJ2482, GJ2212.
MANUFACTURER Farmland Industries, Inc., Centralia, Missouri.
RECALLED BY Manufacturer, by telephone followed by letter August 4, 1992.
Firm-initiated recall complete.
DISTRIBUTION Missouri, Illinois.
QUANTITY (a) 3,463 50-pound bags; (b) 727 50-pound bags were
distributed; firm estimates none remains on the market.
REASON Products manufactured with twice the concentration of
chlortetracycline/sulfathiazole/penicillin as required.
SEIZURES:
PRODUCT Oxygen, USP (92-613-677).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the products' processing, packing, and
holding do not conform to and are not operated and
administered in conformity with current good manufacturing
practice requirements.
FIRM Oxygen Support Systems, Inc., Riverside, New Jersey.
FILED June 29, 1992; U.S. District Court for the District of New
Jersey; Civil #92-2698, FDC #66427.
SEIZED July 7, 1992 - goods valued at approximately $4,000.
-11-
PRODUCT Akne-Mycin (erythromycin) ointment (92-544-652).
CHARGE Adulterated - The product purports to be and is represented
as a drug, the name of which is recognized in an official
compendium, and its strength differs from the standard set
forth in such compendium.
FIRM Stiefel Laboratories, Inc., Oak Hill, New York.
FILED June 16, 1992; U.S. District Court for the Northern
District of New York; Civil #92-CV-771CGC, FDC #66453.
SEIZED June 23, 1992 - goods valued at approximately $5,780.
PRODUCT Cholesterol free pasta (92-635-153).
CHARGE Misbranded - All of the products bear a nutritional claim
that they are cholesterol free, and fail to provide complete
nutritional information as required. All of the products
lack words, statements, and other information required
(i.e., the ingredients statement and location of the
manufacturer) because they are not prominently placed
thereon with such conspicuousness as to render them likely
to be read by the ordinary individual under customary
conditions of purchase, since the letters are less than 1/16
inch in height. Some of the products are foods for which a
standard of identity has been established (angel hair,
fettuccine, and linguine), and their labels fail to bear the
name of the food specified in the regulation. All of the
products are fabricated from two or more ingredients and
their labels fail to list the ingredients in descending
order of predominance.
FIRM Chin Family Foods, Inc., trading and doing business as
International Noodle Company, Philadelphia, Pennsylvania.
FILED August 2, 1992; U.S District Court for the Eastern
District of Pennsylvania; Civil #92-4521, FDC #66471.
SEIZED August 3, 1992 - goods valued at approximately
$645.
PRODUCT "Irish Style" Oatmeal (92-613-410).
CHARGE Misbranded - The product label falsely represents and
suggests that the article is a "high fiber cereal," low in
calories, and contains no cholesterol. The product label
fails to include the street address of the distributor;
the net quantity of contents does not appear on the package
in conspicuous type in distinct contrast with other matter
on the package, and the statement of net quantity of
contents on the package does not contain letters or numerals
in a type size established by regulation in relationship to
the area of the principal display panel of the package.
FIRM I. Epstein and Sons, Inc., Irvington, New Jersey.
FILED June 4, 1992; U.S. District Court for the District of New
Jersey; Civil #92-2350, FDC #66435.
SEIZED June 17, 1992 - goods valued at approximately $800.
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PRODUCT Lemon strips (92-664-531).
CHARGE Adulterated - The product contains cyclamate salt, an unsafe
food additive, in that there is no regulation in effect
describing the conditions under which it may be safely used.
In addition, the product contains saccharin salt, a food
additive which is unsafe because its use is not in
conformance with the regulation which prescribes the
conditions under which it may be safely used.
Misbranded - The product is misbranded because: it is
offered for sale under the name of another food since it is
contained in cases labeled as soup mix base; the label fails
to bear the common or usual name of the food; it is
fabricated from two or more ingredients and its label fails
to declare the presence of saccharin or cyclamate; and, the
product contains saccharin and the label fails to bear the
required saccharin warning statement.
FIRM Wing Coffee Company, Ltd., Honolulu, Hawaii.
FILED July 23, 1992; U.S. District Court for the District
of Hawaii; Civil #92-00477, FDC #66464.
SEIZED July 27, 1992 - goods valued at approximately $1,450.
PRODUCT Canned mushroom pieces and stems (90-611-987/8).
CHARGE Adulterated - The product is unfit for food because it is
contained in rusted, swollen, and leaking cans.
FIRM Commercial Warehousing Co., Philadelphia, Pennsylvania.
FILED September 22, 1992; U.S. District Court for the Eastern
District of Pennsylvania; Civil #92-CV-5491, FDC #66484.
SEIZED September 28, 1992 - goods valued at approximately $2,785.
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END OF ENFORCEMENT REPORT FOR OCTOBER 7, 1992. BLANK PAGES MAY
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