FDA

Enforcement Report

RECALLS AND FIELD CORRECTIONS: CLASS I

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.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

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.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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).

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

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.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

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.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

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.