CODE
Sell by 10/7.
MANUFACTURER
A to Z Sandwich Company, Inc., Jacksonville, Florida.
RECALLED BY
Manufacturer, by telephone beginning October 6, 1998, followed by
visit, and by press release. Completed recall resulted from
sample analysis by the Department of Defense.
DISTRIBUTION
Florida and Georgia.
QUANTITY
160 sandwiches were distributed.
REASON
Product was contaminated with Listeria monocytogenes.
PRODUCT
Sunbird Snacks Yogurt Raisins, in 6 ounce cellophane packages.
Recall #F-033-9.
CODE
EXP 05 99 231.
MANUFACTURER
Mister Snacks, Inc., Cheektowaga, New York (repacker/responsible
firm).
RECALLED BY
Repacker, by telephone and fax of press release between September
30, 1998 and October 2, 1998, and by letter on October 9, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION
Massachusetts and Connecticut.
QUANTITY
172 cases (12/6 ounce packages) were produced on 8/19/98.
REASON
Some bags of product contain undeclared yogurt peanuts.
PRODUCT
Various Sushi Products: a) California Roll Sushi, 9 ounces, under the Niko Niko and Uwajimaya Seattle, WA labels; b) Seattle/California Combo, 9 ounces, under the Niko Niko and Uwajimaya Seattle, WA labels c) Crab Roll Sushi, 9 ounces, under the Niko Niko label; d) Sushi Variety California Roll, 16 ounces, under Sun Luck label e) Sushi Variety Combination Rolls, 16 ounces under the Sun Luck label. Recall #F-034/038-9.
CODE
All Niko Niko and Sun Luck labeled products with a pull date of
"9/24" or earlier and all Uwajimaya labeled products on the
market at the time of the recall.
MANUFACTURER
Kustom Foods, Seattle, Washington.
RECALLED BY
Manufacturer, by visit, fax, press release, and letter on
September 22, 1998. Firm-initiated recall complete.
DISTRIBUTION
Washington state.
QUANTITY
a) 335 bags; b) 155 bags; c) 73 bags; d) 62 bags; e
Undetermined.
REASON
The products contain undeclared ingredients which can elicit reactions in sensitive individuals: a), b), c), and d) contain undeclared egg whites, pollack, and wheat starch. e) contains undeclared egg whites and wheat starch.
PRODUCT
Vegetarian Chicken Salad, in plastic containers (cups) with lids.
Recall #F-043-9.
CODE
5-9-98.
MANUFACTURER
Nature Boy Foods, Inc., New York, New York.
RECALLED BY
Manufacturer, by letter on May 14, 1998. Completed recall
resulted from sample analysis and follow-up by the New York
Department of Agriculture and Markets.
DISTRIBUTION
New York, Pennsylvania, New Jersey.
QUANTITY
Firm estimates none remains on the market.
REASON
Product contained undeclared egg yolks.
PRODUCT
Orchard House of Fruition Healthy & Nutritious brand dried fruit and nut products: a) Health Mix, in 2 ounce bags; b) Macadamia Bessy, in 2 ounce bags; c) Apricots, in 2.25 ounce bags; d) Dried Apricots and Raw Cashews, in 2 ounce bags. Recall #F-044/047-9.
CODE
All codes.
MANUFACTURER
Unknown.
RECALLED BY
Techsmart Marketing, Inc., Irvington, New Jersey (repacker), by
visits in September 1998, and by press release on September 22,
1998. FDA issued a regional press release on September 21, 1998.
Completed recall resulted from sample analysis by the New York
State Department of Agriculture and Markets.
DISTRIBUTION
New York and New Jersey.
QUANTITY
Undetermined.
REASON
Products contained undeclared sulfites.
PRODUCT
Red Crowned Crane brand Dried Potatoes, in 8 ounce flexible
packages. Recall #F-048-9.
CODE
None.
MANUFACTURER
Zhong Shan Cheng Chang Dried Fruits and Company, Zhong Shan,
China.
RECALLED BY
Yick Cheung Trading Corporation, doing business as Good World
Trading Company, Brooklyn, New York (distributor), by visit on
September 15, 1998. Completed field correction (relabeling)
resulted from sample analysis and follow-up by the New York State
Department of Agriculture and Markets.
DISTRIBUTION
New York.
QUANTITY
2 cases (100 bags per case) were distributed.
REASON
Product contained undeclared sulfites.
CODE
The UPC Code is 27500, the recalled retail packages are
identified with the Pull Dates: "FEB 16" or "FEB 17", followed by
six digit code combinations. The six digit codes preceded by the
Pull Date "FEB 16", are: 1B2720, 2B2720, 1C2730, 2C2730, 3C2730,
4C2730, 5C2730, 6C2730. The six digit codes preceded by the Pull
Date "FEB 17", are: 1C2770, 2C2770, 3C2770, 4C2770, 1A2770,
2A2770, 3A2770, 4A2770, 5A2770, 6A2770, 7A2770, 8A2770, 9A2770,
1B2770, 2B2770, 3B2770, 4B2770, 5B2770, 6B2770, 7B2770, 8B2770,
9B2770, 1C2820, 2C2820, 3C2820, 4C2820, 5C2820, 1A2820, 1B2830,
1C2840, 2C2840, 3C2840, 4C2840, 5C2840, 6C2840, 7C2840, 1A2840,
2A2840. The cookies identified by these codes were manufactured
from 9/29/98 to 10/11/98; and were shipped to distributors from
10/4/98 to 10/13/98.
MANUFACTURER
Ellison Bakery, Fort Wayne, Indiana.
RECALLED BY
Archway Cookies, Inc., Ashland, Ohio, by telephone on October 14,
1998. Firm-initiated recall ongoing.
DISTRIBUTION
21 states east of the Mississippi.
QUANTITY
280 cases (6,720 retail packages) were distributed.
REASON
Product may contain pieces of glass.
PRODUCT
Various Sushi Products: a) Nigri Sushi Combo, 10 ounces, under the Niko Niko label and sold at Uwajimaya stores without a brand name; b) Shrimp Roll Sushi, 9 ounces under the Niko Niko label and Uwajimaya label; c) Real Crab Roll, 12.5 ounces sold only at Uwajimaya stores. Recall #F-039/041-9.
CODE
All Niko Niko products with a pull date of "9/24" or earlier and
all Uwajimaya labeled products on the market at the time of the
recall.
MANUFACTURER
Kustom Foods, Seattle, Washington.
RECALLED BY
Manufacturer, by visit, fax, press release, and letter on
September 22, 1998. Firm-initiated recall complete.
DISTRIBUTION
Washington state.
QUANTITY
a) 95 bags; b) 103 bags; c) 10 bags were distributed.
REASON
a) contains undeclared pollack and wheat starch.
b) and c) contain undeclared eggs. However, "mayonnaise" (the
source of the eggs) is listed on the label. An individual who is
sensitive to eggs is likely to avoid the product based on
"mayonnaise" being listed as an ingredient. Hence, the
probability of serious health consequences is remote for
egg-sensitive individuals.
PRODUCT
a) Metaproterenol Sulfate Inhalation Solution, USP, 0.4%, in 2.5
mL Arm-a-Med Plastic Vials, NDC 0186-4131 -01;
b) Metaproterenol Sulfate Inhalation Solution, USP, 0.6%, in 2.5
mL Arm-a-Med Plastic Vials, NDC 0186-4130-01
c) Sodium Chloride Solution, 0.45% for Respiratory Therapy, 3 mL
Arm-a-Vial Plastic Vials, NDC 0186-4101-01, and in 5 mL
Arm-a-Vial Plastic Vials, NDC 01 86-4101-03;
d) Sodium Chloride Solution, 0.9% for Respiratory Therapy, in 3
mL Arm-a-Vial Plastic Vials, NDC 0 1 86-41 00-01, and in 5 mL
Arm-a-Vial Plastic Vials, NDC 0 1 86-4100-03;
e) Sterile Water for Respiratory Therapy in 3 mL Arm-a-Med
Plastic Vials, NDC 0186-4102-01, and in 5 mL Arm-a-Vial Plastic
Vials, NDC 0 1 86-4102-03. Recall #D-013/017-9.
CODE
Lot numbers: a) P33410 (EXP 10/98) and R33508 (EXP 8/99); b)
P26010 (EXP 10/98) and R26311 (EXP 11/99); c) R65209 (EXP 9/99)
and N62611 (EXP 11/98);
d) P53909 (EXP 9/98), R54107 (EXP 7/99), R54208 (EXP 8/99),
R54308 (EXP 8/99), R54408 (EXP 9/99), R54509 (EXP 9/99), R54609
(EXP 9/99), R54709 (EXP 9/99), R54810 (EXP 10/99), R54910
(EXP 10/99), R55010 (EXP 10/99), R55110 (EXP 10/99), R55311 (EXP
11/99), R55412 (EXP 12/99), R55512 (EXP 12/99), N42309 (EXP
9/98), N42409 (EXP 9/98), N42509 (EXP 9/98), N42610 (EXP
10/98),N42711 (EXP 11/98), N42811 (EXP 11/98), P42902 (EXP 2/99),
P43006 (EXP 6/99), P43210 (EXP 10/99), P43311 (EXP 11/99), R43407
(EXP 7/00), R43507 (EXP 7/00), R43607 (EXP 7/00), R43709 (EXP
9/00) and R43810 (EXP 1 0/00);
e) R76911 (EXP 11/00) and P71809 (EXP 8/99).
MANUFACTURER
Centeon L.L.C. Kankakee, Illinois (contract manufacturer).
RECALLED BY
Astra Pharmaceuticals, L.P., Westborough, Massachusetts, by
letter on April 26, 1998. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Volume of Product in Commerce: NACL 0.9% 5 mL: 49,336 units NACL 0.9% 3 mL: 41,790 units NACL 0.45% 3 mL: 1,939 units NACL 0.45% 5 mL: 967 units Metaproterenol Sulfate 0.6% 2.5 mL: 815 units Metaproterenol Sulfate 0.4% 2.5 mL: 1,390 units Sterile Water for Respiratory Therapy 5 mL: 460 units Sterile Water for Respiratory Therapy 5 mL: 529 units
REASON
Some vials exhibit pin-hole leaks.
PRODUCT
a) Hoechst Marion Roussel Carafate (sucralfate) Suspension
containing 1 g. sucralfate per 10 mL, for oral administration,
packaged in 14-fluid ounce glass bottles, Rx, indicated for the
short-term treatment of active duodenal ulcer, NDC #0088-1700-15;
b) Hoechst Marion Roussel Ditropan (oxybutynin chloride) Syrup
containing 5 mg. oxybutynin chloride per 5 mL., for oral
administration, packaged in 16-fluid ounce glass bottles, Rx,
indicated for the relief of symptoms of bladder instability
associated with voiding in patients with uninhibited neurogenic
or reflex neurogenic bladder, NDC #0088-1373-8.
Recall #D-018/019-9.
CODE
Lot numbers: a) 98062379, EXP 07/08/2000,
98062618, EXP 07/14/2000, 98062619, EXP 07/15/2000,
98062748, EXP 07/21/2000, 98062749, EXP 07/22/2000,
98062752, EXP 08/04/2000, 98062753, EXP 08/05/2000,
98064111, EXP 08/18/2000, 98064112, EXP 08/19/2000,
98066839, EXP 10/13/2000; b) 98063621, EXP 07/31/2000.
MANUFACTURER
Hoechst Marion Roussel, Inc. Kansas City, Missouri.
RECALLED BY
Manufacturer, by letter dated September 18, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
a) 229,528 bottles; b) 9,767 bottles were distributed; firm
estimated that 5 percent of product remained on market at time of
recall initiation.
REASON
Bottle defects and/or glass fragments in the product(s).
CODE
Lot numbers: APF015, BAF048, BDF010, BCF013.
MANUFACTURER
Johnson & Johnson/Merck Consumer Pharmaceutical Company,
Lancaster, Pennsylvania.
RECALLED BY
Johnson & Johnson/Merck Consumer Pharmaceutical Company, Fort
Washington, Pennsylvania, by letter mailed on September 28, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Undetermined.
REASON
Mislabeling - The back label incorrectly declares simethicone as
"0" mg, Not 40 mg.
PRODUCT
3.8 mm Calibrated Twist Drill, Part #1741, used with the Humeral
Nail, orthopedic manual surgical instrument intended to be used
by professional surgeons for the treatment of fractures of the
humerus. Recall #Z-176-9.
CODE
All units with lot numbers 537071 or 537072.
MANUFACTURER
Depuy Ace Medical Company, El Segundo, California.
RECALLED BY
Manufacturer, by telephone beginning on September 3, 1998, and by
letter mailed on September 4, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION
Arizona, Arkansas, California, Colorado, Florida, Illinois,
Kentucky, Louisiana, Michigan, New Jersey, New York, Ohio,
Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, Great
Gritain, Japan.
QUANTITY
129 units were distributed.
REASON
The calibrations on the twist drills are incorrect, resulting in
the potential for selection and use of a screw that is too
long.
PRODUCT
CoaguChek Prothrombin Time (PT) Test Strips, used for qualitative prothrombin time testing in fresh capillary or venous whole blood with the CoaguChek systems: a) CoaguChek Test Strips (professional use), Catalog No. 775; b) CoaguChek Test Strips (professional use), Catalog No. 7740; c) CoaguChek test strips for prothrombin time self-testing, Catalog No. 764, Box Lot No. 602330, Strip Pouch No. 066. Recall #Z-191/193-9.
CODE
a) Lot Nos. 066 through 085; b) Lot Nos. 066 through 085; c) Box Lot No. 602330, Strip Pouch No. 066; Box Lot No. 081, Strip Pouch No. 081; and Box Lot No. 772321, Strip Pouch No. 085.
MANUFACTURER
Roche Diagnostics/Boehringer Mannheim Corporation, Indianapolis,
Indiana.
RECALLED BY
Manufacturer, by telephone , followed by letter September 23,
1998. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
Approximately 2.2 million strips were distributed.
REASON
There can be a positive bias in the results with these devices
due to small pinhole in the pouches.
UPDATE
Recall #Z-122/123-8, Biotrack Protime Reagent Cartridges and
CoaguChek Plus Prothrombin Time (PT) Test Cartridges, which
appeared in the November 11, 1998 Enforcement Report is being
replaced with the following:
PRODUCT
a) 1. Biotrack brand and Coumatrak brand Protime Test Cartridges, Catalog Number 473043 bearing lot numbers beginning with the characters P616. This product does not give acceptable recovery with any lots of Biotrack brand or Coumatrak brand Protime Level 2 Controls, Catalog number 1894220, or any lots of Biotrack brand or Coumatrak brand Protime Combination Control Kits [which contain both Level 1 and Level 2 Controls], Catalog number 473044, and all cartridges are being replace. 2. Biotrack brand and Coumatrak brand Protime Test Cartridges, Catalog Number 473043 bearing lot numbers beginning with the characters P702. This product does not give acceptable recovery with the following lots of Biotrack brand or Coumatrak brand Protime Level 1 Controls, Catalog Number 1894210: PN7041, PN7042, PN7043 and PN7044. 3. Biotrack brand and Coumatrak brand Protime Test Cartridges, Catalog Number 473043 bearing lot numbers beginning with the characters P702. This product does not give acceptable recovery with the following lots of Biotrack brand or Coumatrak brand Protime Combination Control Kits [which contain both Level 1 and Level 2 Controls], Catalog number 473044: CPP639, CPP700 and CPP711. b) 1. CoaguChek Plus Coagulation Monitor PT Test Cartidges, Catalog Number 473707, lots bearing a six digit lot number beginning with P616. This product does not give acceptable recovery with the following lots of CoaguChek Plus Coagulation Monitor Level 2 PT Quality Controls, Catalog Number 1894218: PA7051, PA7053, PA7071, PA7072, PA7073 and any higher lot numbers except for PA8041 {PA8041 is acceptable for use with this product]. 2. CoaguChek Plus Coagulation Monitor PT Test Cartidges, Catalog Number 473707, lots bearing a six digit lot number beginning with P616. This product does not give acceptable recovery with the following lots of CoaguChek Plus Coagulation Monitor PT Quality Control Kits [which contain both Level 1 and Level 2 Controls], Catalog Number 473038: CPP640, CPP641, CPP643, CPP648, CPP701, CPP702, CPP703, CPP706, CPP709 and CPP710. 3. CoaguChek Plus Coagulation Monitor PT Test Cartidges, Catalog Number 473707, lots bearing a six digit lot number beginning with P702. This product does not give acceptable recovery with any lots of CoaguChek Plus Coagulation Monitor Level 1 PT Quality Controls, Catalog Number 1894200, or any lots of CoaguChek Plus Coagulation Monitor PT Quality Control Kits [which contain both Level 1 and Level 2 Controls], Catalog Number 473038, and all catridges are being replaced. PT quality controls are used for performance checks of the Coaguchek Plus, Biotrack, and Coumatrak Protime coagulation systems. PT controls are used to verify the reliability of sample measurement and to indicate possible system performance problems. These controls are available in two levels. Level 1 produces a prothrombin time similar to that of a healthy coumarin-free individual. Level 2, deficient in clotting factors, gives a prolonged prothrombin time similar to a patient taking coumarin therapy. Recall #Z-122/123-9.
CODE
See above.
MANUFACTURER
Boehringer Mannheim Corporation, Fremont, California.
RECALLED BY
Boehringer Mannheim Corporation, Indianapolis, Indiana, by
telephone in November 1997, and by letter dated July 1, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide, Australia, Canada, Chili, Germany, Japan,
Switzerland.
QUANTITY
9,427 boxes of CoaguChek plus and 4,479 boxes of Coumatrak
Protime were distributed since November 20, 1996.
REASON
When used with Protime Controls codes listed above, these
cartridges give results which are out published range.
UPDATE Recall #Z-141/143-8, Anesthesia Gas Sampling Elbow and Anesthesia Circuits (Gibeck, Inc., Indianapolis, Indiana), which appeared in the November 11, 1998 Enforcement Report should read:
REASON:BR Possible occlusion of the gas sampling elbow at the gas sampling port orifice.
CODE
a) Lot No. 068003, EXP October 1999; b) Lot Nos. 07363, 07364, and 07367, EXP July 1999; c) Lot Nos. 070068, Exp January 2000; 080004, and 080004A, both EXP July 2000.
MANUFACTURER
Heraeus Kulzer, GmbH & Company, Dormagen, Germany.
RECALLED BY
Heraeus Kulzer, Inc., South Bend, Indiana, by letters dated March
4 and 23, 1998. Firm-initiated recall complete.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
a) 6,887; b) 9,427 units; c) 5,486 units were distributed.
REASON
Samples from the cited lots failed to produce the desired
hardness, and the product failed to adequately perform as
specified.
PRODUCT
Penile Implant, Dilamezinserter Insert, DMI-12G.
Recall #Z-190-9.
CODE
Lot #2985.
MANUFACTURER
Lone Star Medical Products, Inc., Houston, Texas.
RECALLED BY
Manufacturer, by letter October 2, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
253 units were distributed.
REASON
The device handle may break off during surgery.
END OF ENFORCEMENT REPORT FOR NOVEMBER 18, 1998. BLANK PAGES MAY FOLLOW.