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
12/30/1992
RECALLS AND FIELD CORRECTIONS: December 30, 1992
FOODS -- CLASS I
92-53
PRODUCT Zurheide Das Beste frozen desserts:
(a) Lite Vanilla Ice Milk; in half-gallon containers;
(b) Lite Tin Roof Sundae Ice Milk, in half-gallon containers;
(c) Malted Milk Ice Cream, in 5 quart containers.
Recall F-144/146-3.
CODE Date code 218 on ice milk products and 239 on the malted milk
ice cream.
MANUFACTURER Zurheide Ice Cream Company, Inc., Sheboygan, Wisconsin.
RECALLED BY Manufacturer, by telephone October 27, 1992, and November 6,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Wisconsin.
QUANTITY Approximately (a) 1,000 containers; (b) 1,000 containers;
(c) 100 containers were distributed.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT Dromedary Diced Pimientos, in 2 ounce glass jars.
Recall #F-147-3.
CODE 2I16WGA.
MANUFACTURER Specialty Brands, Inc., Woodbury, Georgia.
RECALLED BY Specialty brands, Division of Burns Philip Food, Inc., San
Francisco, California, by memorandum December 7, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Unknown.
QUANTITY 6 cases were distributed.
REASON The product's pH is above 4.6. That creates a remote
possibility for the growth of Clostridium botulinum.
PRODUCT Double Coin brand Pieces and Stem Mushrooms, in 6 pound 5 ounce
cans. Recall #F-158-3.
CODE NBRPC-443 Pieces and Stems Mushrooms.
MANUFACTURER Kenmor Bros., Taipei, Taiwan.
RECALLED BY Pong Chien Trading, Brooklyn, New York, by telephone September
16, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Georgia and Pennsylvania.
QUANTITY 396 cans were distributed; 5,304 cans frozen in recalling firm
warehouse.
REASON Product contaminated with Staphylococcal enterotoxin.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT Vitarroz Canned Shrimp, 4.25 ounces. Recall #F-134-3.
CODE All lots.
MANUFACTURER Sonkla Canning Bangkok, Thailand.
RECALLED BY Vitarroz Corporation, Jersey City, New Jersey, by letter May
18-26, 1992. Firm-initiated recall complete.
DISTRIBUTION New York, Connecticut, New Jersey, Pennsylvania, Massachusetts.
QUANTITY 1,188 cases were distributed; firm estimates none remains on
the market.
REASON Product is decomposed.
PRODUCT Multivitamin oral liquids:
(a) Daily Vitamin Liquid, a sugar free vitamin packaged in 1
pint amber plastic bottles labeled as a Bulk Container, Not for
Household Use, under the following labels:
PBI Daily Vitamin Liquid, Manufactured by Pharmaceutical
Basics, Inc.; Syrvite Daily Vitamins, Manufactured by
Pharmaceutical Basics, Inc., for Major Pharmaceutical Corp.,
Bal-Daylin Liquid, Dist. by J.J. Balan, Inc.,
(b) Multi-Vita Drops, a sugar-free vitamin packaged in 50 ml
plastic bottles with droppers; under the following labels:
Valumed Multi-Vita-Drops Multivitamin Supplement, distributed
by Moore Medical Corp.;
(c) Multi-Vita Drops with Iron, a sugar-free vitamin packaged
in 50 ml plastic bottles with droppers, under the following
labels:
Major Multi-Vita-Drops with Iron Multivitamin Supplement
Infants' Drops, manufactured for Major Pharmaceutical
Corporation, distributor; Direct Formulary Infants'
Multivitamin and Iron Supplement Infants' Drops, Mfd. for Amway
Corporation. Recall #F-140/142-3.
-2-
CODE (a) Product #8469: lot #18786, 18910, 18974, 19042, 19128,
19226, 19295
(b) Product #8614: lot #18983, 19136, 19401
(c) Product #8619: lot #18795, 19166, 19399
MANUFACTURER Pharmaceutical Basics, Inc., Morton Grove, Illinois.
RECALLED BY Manufacturer, by letter November 13, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 20,425 bottles; (b) 8,377 bottles; (c) 18,726 bottles were
distributed.
REASON Product is mislabeled -- does not maintain ascorbic acid
potency throughout expiration period.
PRODUCT Royalty brand Tomato Paste, in 7 pound cans. Recall #F-143-3.
CODE Code 08J1037 is printed on the top of some cans. Codes
08J1109, 08J1183, and 08J1884 are engraved on the bottom of the
can.
MANUFACTURER Deko Food Processing Corporation, Debrecon, Hungary.
RECALLED BY Camerican International, Teaneck, New Jersey, by letter October
15, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, Florida, Virginia, New Jersey, Alabama.
QUANTITY 1,439 cases (6 cans per case) were distributed.
REASON Product contained in swollen cans.
PRODUCT Green Boiled Peanuts in hermetically sealed metal cans, 8
ounces, under Roddenbery's Peanut Patch label and Thrifty Maid
label. Recall #F-159-3.
CODE Lot numbers: 199R2/SBPB, 200R2/SBPB, 203R2/SBPB,
204R2/SBPB, 205R2/SBPB, 205R2/SBPA, 210R2/SBPB, 210R2/SBPA
(Roddenbery label), 204R2/SBPA and 206R2/SBPB (Thrifty Maid
label).
MANUFACTURER W.B. Roddenbery Company, Inc., Cairo, Georgia.
RECALLED BY Manufacturer, by memorandum August 20, 1992, followed by
visit. Firm-initiated recall complete.
DISTRIBUTION Southeastern United States.
QUANTITY Approximately 32,844 cases (24 cans per case) were distributed.
REASON Product is spoiled and contained in leaking and defective cans.
PRODUCT French Style Green Beans, in 8 ounce cans, under the Giant,
Montco, Red & White, Lane Country and Tops labels.
Recall #F-160-3.
CODE GCK71/3328E.
MANUFACTURER Seneca Foods Corporation, Geneva, New York.
RECALLED BY Seneca Foods, Marion, New York, by letter September 30, 1992.
Firm-initiated recall complete.
DISTRIBUTION Missouri, Pennsylvania, Massachusetts, New York, Maryland,
Wisconsin.
-3-
QUANTITY 738 cases (24 cans per case) were distributed; firm estimates
only small quantities remain on the market.
REASON Product is in leaking and defective cans.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Various Rx small volume parenterals for the production of local
or regional anesthesia, single dose 30 ml ampules, 5 units per
carton:
(a) 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Injection
Bupivacaine and Epinephrine Injection, USP, for nerve block,
caudal and epidural anesthesia only;
(b) 0.75% Bupivacaine HCl and Epinephrine 1:200,000 Injection
Bupivacaine and Epinephrine Injection, USP, for epidural and
retrobulbar anesthesia only;
(c) Lidocaine HCl 1% and Epinephrine 1:200,000 Injection
Lidocaine and Epinephrine Injection, USP, for infiltration and
nerve block including epidural and caudal;
(d) Lidocaine HCl 1.5% and Epinephrine 1:200,000 Injection
Lidocaine and Epinephrine Injection, USP, for infiltration and
nerve block including epidural and caudal. Recall #D-078/081-3.
CODE Lot numbers: (a) 64-566-DK; (b) 64-567-DK; (c) 64-541-DK,
62-614-DK, 67-095-DK; (d) 66-492-DK.
MANUFACTURER Abbott Laboratories, Rocky Mount, North Carolina.
RECALLED BY Abbott Laboratories, Abbott Park, Illinois, by letter December
4, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 2,025 ampules; (b) 1,900 ampules; (c) 7,425 ampules;
(d) 2,625 ampules were distributed.
REASON Subpotency of epinephrine ingredient.
PRODUCT Goldline brand Liquid Antacid Genaton, an OTC combination
ingredient drug product, in 12 ounce plastic bottles.
Recall #D-092-3.
CODE Lot numbers: 16-07122 and 16-33521.
MANUFACTURER Custom Packaging Services, Inc. (CPS), West Palm Beach, Florida.
RECALLED BY Manufacturer, by letter November 6, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,088 12-ounce bottles of lot 33521 and 5,081 12-ounce bottles
of lot 07122 were distributed; firm estimates less than 20
percent of product remains on the market.
REASON Bacterial contamination.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Deconsal II, a Rx drug for the temporary relief of nasal
congestion and cough associated with respiratory tract
infections and related conditions, in 500 tablet bottles.
Recall #D-082-3.
-4-
CODE Lot numbers: 2C1710, 2C1712, 2C1713, 2D1717, 2D1725, 2G1731,
2G1732, 2G1733, 2G1734, 2L1744 -- all lots manufactured.
MANUFACTURER Adams Laboratories, Inc., Fort Worth, Texas.
RECALLED BY Manufacturer, by letter December 2, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 15,374 bottles were distributed.
REASON Guaifenesin ingredient does not meet dissolution specifications.
PRODUCT Dyazide, Triamterene 50 mg/Hydrochlorothiazide 25 mg capsules
for oral use, in single unit dose blister packages of 100, in
bottles of 100 and 1,000 capsules, a Rx diuretic
anti-hypertensive. Recall #D-083-3.
CODE All codes with lot number sequences ending in 9E90.
MANUFACTURER Smithkline Beecham Pharmaceuticals, Cidra, Puerto Rico.
RECALLED BY Manufacturer, by letter November 9, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,773,481 units were distributed.
REASON Product does not meet dissolution specifications.
PRODUCT Phenazopyridine HCl Tablets: (a) 100 mg; (b) 200 mg, in
bottles of 100 and 1,000, Rx analgesic for urinary tract
infections, under the following labels: Amide, Rugby, Geneva
Generics, H.L. Moore, ParMed, Schein, UDL, and URL.
Recall #D-084/085-3.
CODE Lot numbers: (a) 91170 EXP 9/93, 91171 EXP 9/93, 91210 EXP
11/93, 91211 EXP 11/93, 91259 EXP 12/93;
(b) 91167 EXP 8/93, 91187 EXP 10/93, 91192 EXP 10/93, 91212 EXP
11/93, 91213 EXP 11/93, 92027 EXP 3/94, 92037 EXP 3/94, 92049
EXP 3/94.
MANUFACTURER Amide Pharmaceuticals, Inc., Little Falls, New Jersey.
RECALLED BY Manufacturer, by letter August 26, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY (a) 8,181,700 tablets; (b) 11,626,100 tablets were distributed;
firm estimates 6.5 million tablets remain on the market.
REASON Product does not meet dissolution specifications.
PRODUCT Various alcohol products in plastic transparent bottles:
(a) Isopropyl Alcohol 70%, 16 fluid ounce and 1 gallon bottles;
(b) Green Isopropyl Alcohol 70%, in 16 fluid ounce and 1 gallon
bottles;
(c) Frescol Ethyl Alcohol 70%, in 16 fluid ounce and 1 gallon
bottles;
(d) Alcoholado Yerba Buena (70% Ethyl Alcohol), in 12 fluid
ounce bottles. Recall #D-086/089-3.
CODE All lots manufactured prior to 10/26/92.
MANUFACTURER Verpas Products, Inc., Carolina, Puerto Rico.
RECALLED BY Manufacturer, by letter November 16, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Puerto Rico.
-5-
QUANTITY Unknown.
REASON Subpotency.
PRODUCT Lindane Lotion, USP 1%, a Rx topical parasiticide for the
treatment of patients infested with scabies, in 16 ounce amber
plastic bottles, under the following labels: PBI, Schein,
Qualitest, Rugby. Recall #D-090-3.
CODE Lot #18828 EXP 2/93.
MANUFACTURER Pharmaceutical Basics, Inc., Morton Grove, Illinois.
RECALLED BY Manufacturer, by telephone, October 23-27, 1993.
Firm-initiated recall complete.
DISTRIBUTION Texas, Ohio, Florida, Alabama, New York, Virginia, Illinois.
QUANTITY 5,987 bottles were distributed; firm estimates none remains on
the market.
REASON Non-homogeneous product.
PRODUCT Capitrol (chloroxine 2%) Shampoo, 4 ounce bottles, a Rx
dandruff shampoo for the treatment of dandruff and seborrheic
dermatitis. Recall #D-091-3.
CODE Lot #685E007 EXP 9/94.
MANUFACTURER Westwood Squibb, Buffalo, New York.
RECALLED BY Manufacturer, by letter December 17, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 11,688 units were distributed.
REASON Product separation.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Posterior Segment System (PSS), accessory to augment series Ten
Thousand Ocutome Primary Console, Model 503. Recall #Z-109-3.
CODE Serial numbers 553 through 764.
MANUFACTURER Alcon Surgical, Inc., Irvine, California.
RECALLED BY Manufacturer, by letter August 18, 1992. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 188 units were distributed.
REASON The transformer may fail which may cause the fuse in the PSS or
the fuse in the Ocutome Console to blow. If the Ocutome's fuse
blows, the entire system shuts down. If the PSS fuse blows,
the fluid/gas system and illumination will not function.
PRODUCT Vitrectomy Cassette, external component of Series Ten Thousand
Ocutome System Console, used for vitreous surgical procedures.
Recall #Z-114-3.
CODE Catalog #1085, lot #92224, sterile lot #M46725.
MANUFACTURER Alcon Surgical, Inc., Irvine, California.
-6-
RECALLED BY Alcon Laboratories, Inc., Fort Worth, Texas, by telephone
October 1, 1992, followed by letter October 6, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 86 cases (6 units per case) were distributed.
REASON The internal cassette silicone tubing (pressure actuation line)
may become disconnected during use.
PRODUCT Acufex Cannulated Screwdrivers:
(a) 7 mm Cannulated Driver with Large Handle, Part No. 013108;
(b) 9 mm Cannulated Driver with Large Handle, Part No. 013109;
(c) 7 mm Cannulated Driver with Small Handle, Part No. 013426;
(d) 9 mm Cannulated Driver with Small Handle, Part No. 013427;
(e) Screw System with Large Handle, Part No. 013470, Kits, may
contain any large handle Lot No. listed above;
(f) Screw System with Small Handle, Part No. 013471, Kits may
contain any small handle Lot No. listed above.
Recall #Z-135/140-3.
CODE (a) Lot Nos. L190, L191, L291, L391, L491;
(b) Lot Nos. L190, L290, L191, L291;
(c) Lot Nos. L189, L190, L290, L390, L490, L191, L291, L391;
(d) Lot Nos. L189, L190, L290, L390, L490, L191, L291, L391;
(e) Part No. 013470, Kits, may contain any large handle Lot No.
listed above;
(f) Part No. 013471, Kits may contain any small handle Lot No.
listed above.
MANUFACTURER Acufex Microsurgical, Inc., Mansfield, Massachusetts.
RECALLED BY Manufacturer, by letter August 10, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 945 units were distributed.
REASON The devices may fail if excessive torque is placed on the tip
of the instrument during surgery.
PRODUCT 3M Red Dot Monitoring Electrodes, Radiolucent with Clear Tape
and Solid Gel, a pre-gelled, disposable, silver/silver chloride
electrode for electro-cardiographic monitoring.
Recall #Z-142-3.
CODE All lots of Catalog #2234.
MANUFACTURER Medical Device Division, 3M Health Care, Hinsdale, Illinois.
RECALLED BY Surgical Division, 3M Health Care, St. Paul, Minnesota, by
letter October 8, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Georgia, Illinois, North Carolina, Kentucky, Minnesota,
Michigan, Canada, The Netherlands, Japan, Switzerland, Italy,
UK.
QUANTITY 174,750 electrodes were distributed; firm estimates 20,000
electrodes remain on the market.
REASON Some of the electrodes failed the defibrillation overload
recovery test of the AAMI Standard for Disposable ECG
electrodes, after accelerated aging at elevated temperatures.
-7-
PRODUCT McGaw HyperFormer System, a volumetric total parenteral
nutrition (TPN) compounder designed primarily for use in
hospital pharmacies to mix nutritional IV hyperalimentation
solutions. Recall #Z-144-3.
CODE Units within the serial number range G1000 through G1403. Only
units distributed with software versions E and E1.
MANUFACTURER McGaw, Inc., Carrollton, Texas.
RECALLED BY Manufacturer, by letter October 28, 1992. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY Approximately 289 units were distributed.
REASON Intermittent relay failure may cause pumps to deliver out of
sequence resulting in nutritional solutions being incorrectly
mixed.
PRODUCT COBE Cell Processing Disposable Set, used with the COBE 2991
Blood Cell Processor to process blood and cellular components.
Recall #Z-163-3.
CODE Catalog #912647-819.
MANUFACTURER COBE BCT, Inc., Lakewood, Colorado.
RECALLED BY Manufacturer, by telephone November 5, 1992 and by letter
November 17, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, New Jersey, New York, Massachusetts, Connecticut,
Maryland, Virginia, Washington, D.C., West Virginia, Texas,
Nebraska, Missouri, Arizona, France, Turkey, Spain, Federal
Republic of Germany.
QUANTITY 2,580 bags/215 cases (12 bags per case) were distributed.
REASON Some of the Processing bags were misassembled along the seam in
such a way as to cause leaks while in use in the COBE 2991
centrifuge.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT Medium Narrow Blade, 18.5 mm x 7.0 mm, Part #2296-3-113, a
cutting accessory for orthopedic bone saw. Recall #Z-152-3.
CODE Lot #92070281.
MANUFACTURER Stryker Corporation, Instruments Division, Kalamazoo, Michigan.
RECALLED BY Manufacturer by letter September 25, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION California, Massachusetts, Oregon, New York, North Carolina.
QUANTITY 9 boxes were distributed.
REASON The individual package label may be missing.
PRODUCT Cross-Cut Fissure Carbide Bur, 2.1 mm, Part #277-10-221.
Recall #Z-153-3.
CODE Lot #92050211.
MANUFACTURER Stryker Corporation, Instruments Division, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter June 26, 1992. Firm-initiated recall
complete.
-8-
DISTRIBUTION Missouri, Tennessee, Texas, California, Washington state.
QUANTITY 84 units were distributed.
REASON The package may contain a 1.6 Cross-Cut Fissure Carbide Bur,
Part #277-10-216 instead of the 2.1 mm Bur, Part #277-10-221
which is what the label indicates.
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II
PRODUCT Pig and Sow Wormer with Tramisol (Levamisole Hydrochloride), in
50 pound bags. Recall #V-007-3.
CODE Lot #41891535.
MANUFACTURER Tennessee Farmers Co-Op, Rockford, Tennessee.
RECALLED BY Manufacturer, by telephone December 3, 1991. Firm-initiated
recall complete.
DISTRIBUTION Tennessee.
QUANTITY 119 bags were distributed.
REASON Subpotency of active ingredient.
PRODUCT (a) Isopropyl Alcohol, a single ingredient non-Rx veterinary
anti-infective in a clear plastic one gallon container;
(b) Propylene Glycol, a single ingredient non-Rx veterinary
pharmaceutic aid in a clear plastic one gallon container;
(c) Mineral Oil, a single ingredient veterinary drug for the
promotion of intestinal evacuation in clear plastic one gallon
containers. Recall #V-008/010-3.
CODE Lot numbers: (a) 2-92 and 63-0; (b) 2-92; (c) 5-92 and 55-92.
MANUFACTURER L & M Pharmaceuticals, Dallas, Texas.
RECALLED BY Manufacturer, by letter July 28, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Texas, Arkansas, Louisiana, Oklahoma.
QUANTITY (a) 104 containers; (b) 55 containers; (c) 110 containers were
distributed.
REASON No expiration dates on labels.
-9-
END OF ENFORCEMENT REPORT FOR DECEMBER 30, 1992. BLANK PAGES MAY
FOLLOW.
###