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
02/16/1994
Recalls and Field Corrections: Foods -- Class II -- 02/16/1994
February 16, 1994 94-7
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Preserved Vegetable (cabbage), 1 pound 5 ounces, a condiment
used by the Chinese American community. Recall #F-530-3.
CODE None.
MANUFACTURER United Asian Foods Company, Ltd., (importer), Vernon,
California.
RECALLED BY Manufacturer, by visit April 8, 1993. Firm-initiated recall
complete.
DISTRIBUTION California.
QUANTITY 150 cases (18 jars per case).
REASON Product is contaminated with lead.
_______________
PRODUCT Various cheeses:
1. Monterey Jack Cheese, bulk
2. Colby Cheese, bulk
3. Co-Jack (Monterey Jack and Colby Cheese combined)
4. Cheese, bulk
5. Cheddar Cheese, bulk
6. Natural Monterey Jack Cheese
7. Natural Colby Cheese
8. Longhorn Style Colby Cheese
9. Monterey Jack Cheese
10. Midget Longhorn Style Colby Cheese
11. Natural Midget Longhorn Style Colby Cheese
12. Natural Mild Colby Cheese
13. Natural Brick Cheese
14. Colby Cheese
15. Longhorn Style Mild Colby Cheese
16. Brick Cheese. Recall #F-252/266-4.
CODE Bulk cheese in 640 pound blocks:
Monterey Jack Cheese, production dates 12-4-93, 12-6-93,
12-11-93, 12-13-93 and 12-18-93
Colby Cheese, production dates 12/2/93, 12-3-93, 12-8-93,
12-9-93, 12-10-93, 12-14-93, 12-15-93, 12-16-93, 12-17-93,
12-22-93, and 12-24-93
Co-Jack (Monterey Jack Cheese and Colby Cheese combined
together), production dates 12-14-93 and 12-26-93
Cheddar Cheese, production dates 12-7-93 and 12-14-93 Each
640 pound block of cheese is labeled by a tag which
identifies the type of cheese, plant number, 27-355, date of
production, and the vat number.
Retail packages of cheese:
Cheese products distributed by Associated Milk Producers,
Inc., Portage, WI:
State Brand Natural Monterey Jack Cheese, Net Wt. 5 pounds,
Sell-by May 28, 94
State Brand Natural Colby Cheese, Net Wt. 5 Lbs., Sell by
May 21, 94
Wisconsin State Brand Longhorn Style Colby Cheese, Net Wight
15 ounces, Sell by May 27, 94
Wisconsin State Brand Monterey Jack Cheese, Net Wt. 32
ounces, Sell by May 27, 94
Wisconsin State Brand Midget Longhorn Style Colby Cheese,
Net Wt. 32 ounces, Sell by May 23, 94
Wisconsin Quality Longhorn Style Colby Cheese, Net Weight 15
ounces, Sell by May 27, 94
Cheese products distributed by Topco Assoc. Inc., Skokie,
IL:
Food Club 100% Natural Longhorn Style Colby Cheese, Net Wt.
8 ounces, Sell by May 27, 94
Food Club 100% Natural Midget Longhorn Style Colby, Net Wt.
12 ounces, Sell by June 3, 94
Food Club Colby, Net Wt. 30 ounces, Sell by May 20, 94 and
May 22, 94
Food Club Colby, Net Wt. 15 ounces, Sell by May 20, 94
Cheese products distributed by Meijer, Inc., Grand Rapids,
MI:
Meijer 100% Natural Longhorn Style Colby, Net Wt. 10 ounces,
Sell by May 27, 94
Meijer 100% Natural Midget Longhorn Style Colby, Net Wt. 12
ounces, Sell by May 27, 94
Meijer Colby Cheese, Net Wt 15 ounces, Sell by May 20, 94,
May 27, 94, and May 29, 94
Cheese distributed by American Seaway Foods, Inc.,
Cleveland, OH:
Seaway Longhorn Style Colby Cheese 100% Natural, Net Wt. 8
ounces, Sell by May 27, 94
-2- Cheese distributed by Schnuck Markets, Inc., Bridgeton, MO:
Schnucks Natural Colby Cheese, Net Wt. 13 ounces, Sell by
May 27, 94
Cheese products distributed by Shurfine-Central Corp.,
Northlake, IL:
Shur-fresh Natural Monterey Jack Cheese, Net Wt. 8 ounces,
Sell by May 30, 94
Shur-fresh Natural Colby Cheese, Net Wt. 8 ounces, Sell by
May 22, 94
Shur-fresh Natural Mild Colby cheese, Net Wt. 12 ounces,
Sell by May 21, 94
Shur-fresh Natural Colby Cheese, Net Wt. 15 ounces, Sell by
May 22, 94, May 29, 94 and May 30, 94
Shur-fresh Natural Midget Longhorn Style Colby Cheese, Net
St. 16 ounces, Sell by May 22, 94
Shur-fresh Natural Brick Cheese, Net Wt. 15 ounces, Sell by
May 29, 94
Shur-fresh Natural Longhorn Style Colby Cheese, Net Wt. 15
ounces, Sell by May 21, 94 and May 30, 94
Shur-fresh Natural Colby Cheese, Net Wt. 15 ounces, Sell by
May 20, 94
Shur-fresh Natural Longhorn Style Colby Cheese, Net Wt. 32
ounces, Sell by May 22, 94
Cheese products distributed by Boomsma's, Portage, WI:
Boomsma's Longhorn Style Colby Cheese, Net Wt. 15 ounces,
Sell by May 23, 94
Boomsma's Colby Cheese, Net Wt 15 ounces, Sell by May 27, 94
Boomsma's Colby Cheese, Net Wt. 10 ounces, Sell by May 27,
94 and Jun 5, 94
Boomsma's Monterey Jack cheese, Net Wt. 10 ounces, Sell by
Jun 4, 94
Boomsma's Colby Cheese, Net Wt. 5 Lb., Sell by May 21, 94
Boomsma's Longhorn Style Colby Cheese, Net Wt. 1 Lb., Sell
by May 20, 94
Cheese products distributed by Bar-S Foods Co., Phoenix, AZ:
Bar S Monterey Jack Cheese, Net Wt. 16 ounces, Sell by May
30, 94
Bar S Monterey Jack Cheese, Net Wt. 32 ounces, Sell by Jun
3, 94
Bar S Natural Colby Cheese, Net Wt. 15 ounces, Sell by May
22, 94
Bar S Longhorn Style Natural Colby Cheese, Net Wt. 15
ounces, Sell by May 22, 94
Bar S Longhorn Style Natural Colby Cheese, Net Wt. 30
ounces, Sell by May 23, 94
Cheese products distributed by Aldi, Inc., Batavia, IL:
Happy Farms Longhorn Style Mild Colby Cheese, Net St. 10
ounces, Sell by May 23, 94
Happy Farm's Midget Longhorn Style Colby Cheese, Net St. 16
ounces, Sell by May 20, 94 and Sell by May 22, 94
-3- Cheese products distributed by Wisconsin's Finest, Inc.,
Plano, TX:
Wisconsin's Finest Monterey Jack Cheese, Net St. 10 Lbs.,
Sell by May 28. 94
Wisconsin's Finest Colby Cheese, Net Wt. 16 ounces, Sell by
Aug 27, 94 Wisconsin's Finest Monterey Jack Cheese, Net Wt.
16 ounces, Sell by Aug 27, 94
Cheese products distributed by Dutch Farms, Portage, WI:
Dutch Farms Colby Cheese, Net Wt. 8 ounces, Sell by May 22,
94
Dutch Farms Colby Cheese, Net Wt. 15 ounces, Sell by May 21,
94, May 27, 94 and May 30. 94
Dutch Farms Colby Cheese, Net Wt. 20 ounces, Sell by May 23,
94 and May 30, 94
Dutch Farms Monterey Jack Cheese, Net Wt. 8 ounces, Sell by
May 29, 94
Dutch Farms Monterey Jack Cheese, Net Wt. 15 ounces, Sell by
May 29. 94 and Jun 28, 94
Dutch Farms Brick Cheese, Net Wt 15 ounces, Sell by Jun 28,
94
Cheese products distributed by I & K Dist., Delphos, OH:
Voder's Colby, Net Wt. 8 ounces, Sell by May 22, 94
Voder's Colby Cheese, Net Wt 15 ounces, Sell by May 27, 94
Voder's Colby Cheese, Net Wt 20 ounces, Sell by May 23, 94
and May 30, 94
Voder's Monterey Jack, Net Wt. 15 ounces, Sell by Jun 28, 94
Cheese products distributed by Innovative Sales,
Minneapolis, MN:
Wisconsin Select Midget Longhorn Style Colby Cheese, Net Wt.
16 ounces, Sell by May 22, 94
Wisconsin Select Colby Cheese, Net Wt 15 ounces, Sell by May
20, 94
Wisconsin Select Colby Longhorn Cheese, Net Wt. 15 ounces,
Sell by May 30, 94
Wisconsin Select Monterey Jack Cheese, Net Wt. 15 ounces,
Sell by May 29, 94
Cheese products distributed by Armour Food Companies, Dist.,
Monroe, WI:
Miss Wisconsin Armour Longhorn Style Colby Cheese, Net 15
ounces, Sell by May 30, 94
Miss Wisconsin Armour Colby Cheese, Net Wt. 15 ounces, Sell
by May 30, 94
Cheese distributed by Appleton Cheese Co., Monroe, WI:
Monterey Jack Cheese, Net Wt. 15 ounces, Sell by May 29, 94
Cheese distributed by Star Market Co., Cambridge, MA:
Star Colby Cheese, Net Wt 15 ounces, Sell by May 27, 94
Cheese distributed by Stater Bros. Markets, Colton, CA:
Stater Bros. Monterey Jack Cheese, Net St. 9 ounces, Sell by
May 30, 94
MANUFACTURER Associated Milk Producers, Inc., Rochester, Minnesota
(bulk).
-4- RECALLED BY Associated Milk Producers, Inc., New Ulm, Minnesota,
telephone January 7, 1994 (640 pound blocks) and by letters
dated January 11, 1994 (retail packages). Firm-initiated
recall ongoing.
DISTRIBUTION Minnesota, Indiana, Wisconsin, Missouri, Arizona,
California, Colorado, Illinois, Massachusetts, Pennsylvania,
Texas.
QUANTITY Approximately 1,500 640-pound blocks and 123,440 pounds of
retail packaged cheese were distributed.
REASON Products are contaminated with pieces of metal.
_______________
PRODUCT Yoder's Horseradish in 4.5 ounce, 8 ounce, and 16 ounce
glass bottles. Recall #F-267-4.
CODE All products made after May 23, 1993, with pull dates of NOV
23 through May 23.
MANUFACTURER I & K Distributors, Inc., Delphos, Ohio.
RECALLED BY Manufacturer, by letter November 29, 1993. Firm-initiated
recall complete.
DISTRIBUTION Ohio, Michigan, Illinois, Kentucky, Pennsylvania, Indiana.
QUANTITY 1,471 cases (4.5 ounce jars); 6,766 cases (8 ounce jars);
1,238 cases 16 ounce jars were distributed; firm estimates
798 of 4.5 ounce 3,462 of 8 ounce and 498 jars of 16 ounce
product remains on the market.
REASON Product contains undeclared sodium bisulfite.
_______________
PRODUCT Celebrate party Sugars, colored sugar crystals, in 10 ounce,
8.5 ounce, and 4 ounce bags/bottles. Recall #F-270-4.
CODE None.
MANUFACTURER C & H Sugar Company, Crockett, California.
RECALLED BY Select Origins, Inc., Yaphank, New York, by telephone
beginning December 17, 1993, followed by letter December 27,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 275 dozen bottles were distributed; firm
estimates none remains on the market.
REASON Product contains undeclared FD&C Yellow No. 5.
_______________
PRODUCT Various cheeses:
1. Colby Cheese, Hunk
2. Medium Pinconning Cheese
3. Sharp Pinconning Cheese
4. Sharp Frankenmuth Cheese
5. Natural Co-Jack Cheese Longhorn Style
6. Natural Monterey Jack Cheese
7. Natural Colby Cheese
8. Natural Colby Cheese Longhorn Style
9. Natural Colby Longhorn Style Cheese, sliced
10. Fullmoon Longhorn Style Colby Cheese
11. Natural Fancy Shredded Monterey Jack Cheese
-5- 12. Natural Sliced Muenster Cheese
13. Slab Cut Longhorn Style Colby Cheese
14. Variety Pack (Natural Sliced Mild Cheddar,
Monterey Jack, Colby and Swiss) Cheese
15. Natural Shredded Monterey Jack Cheese
16. Monterey Jack Cheese
17. Brick Cheese
18. Shredded Monterey Jack Cheese
19. Fullmoon Colby Cheese. Recall #F-271/289-4.
CODE Cheese Products distributed by Kroger Co., Cincinnati, OH:
Kroger Colby Cheese Hunk, Net Wt. 24 ounces, Sell by MAY 29
94R
Kroger Medium Pinconning Cheese, Net Wt. 15 ounces, Sell by
MAY 22 94R and MAY 30 94R
Kroger Sharp Pinconning Cheese, Net Wt. 15 ounces, Sell by
MAY 30 94R
Kroger Sharp Frankenmuth Cheese, Net Wt. 15 ounces, Sell by
MAY 30 94R
Kroger Natural Co-Jack Cheese Longhorn Style, Net Wt. 13
ounces, Sell by MAY 22 94R, MAY 23 94R, MAY 30 94R, JUN 3
94R, JUN 4 94R, and JUN 5 94R
Kroger Natural Monterey Jack Cheese, Net Wt. 12 ounces, Sell
by JUN 3 94R
Kroger Natural Colby Cheese, Net Wt. 32 ounces, Sell by MAY
30 94R and JUN 4 94R
Kroger Natural Colby Cheese Longhorn Style, Net Wt. 13
ounces, Sell by JUN 4 94R
Kroger Natural Monterey Jack Cheese, Net Wt. 32 ounces, Sell
by MAY 29 94R, JUN 3 94R, and JUN 4 94R
Kroger Natural Colby Longhorn Style Cheese, Net Wt. 10
ounces, Sell by MAY 30 94R
Kroger Natural Colby Longhorn Style Cheese Sliced, Net Wt.
10 ounces, Sell by MAY 28 94R
Kroger Fullmoon Longhorn Style Colby Cheese, Net Wt. 12
ounces, Sell by MAY 23 94R, MAY 30 94R, JUN 3 94R and JUN 6
94R
Kroger Natural Fancy Shredded Monterey Jack Cheese, Net Wt.
6 ounces, Sell by MAY 29 94R and JUN 4 94R
Kroger Natural Sliced Muenster Cheese, Net Wt. 8 ounces,
Sell by JUN 5 94R
Kroger Natural Colby Longhorn Style Cheese, Net Wt. 16
ounces, Sell by MAY 29 94R
Kroger Slab Cut Longhorn Style Colby Cheese, Net Wt. 14
ounces, Sell by JUN 3 94R
Kroger Variety Pack Natural Sliced Mild Cheddar, Monterey
Jack, Colby, and Swiss Cheese, Net Wt. 13 ounces, Sell by
MAY 27 94R, MAY 28 94R and JUN 3 94R
Kroger Natural Shredded Monterey Jack Cheese, Net Wt. 8
ounces, Sell by JUN 3 94R
Kroger Natural Colby Cheese, Net Wt. 32 ounces, Sell by JUN
5 94R
Kroger Natural Colby Cheese, random weights varying from 9
-6- to 32 ounces, Sell by 05 30 94, 05 31 94, and 06 03 94
Cheese distributed by Pace Dairy Foods Co., Cincinnati, OH:
Borden Monterey Jack Cheese, Net Wt. 12 ounces, Sell by JUN
5 94 and AUG 5 94
Cheese Products distributed by Dillon's Stores, Hutchinson,
KS 67501:
Dillons Longhorn Style Colby Cheese, Net Wt. 10 ounces, Sell
by MAY 15 94 and JUN 5 94R
Dillons Colby Cheese, Net Wt. 8 ounces, Sell by JUN 5 94R
Cheese Products distributed by Topco Assoc. Inc., Skokie,
IL:
Food Club Longhorn Style Colby Cheese, Net Wt. 15 ounces,
Sell by May 30 94R
Food Club Colby Cheese, Net Wt. 15 ounces, Sell by MAY 28
94R Cheese Products distributed by IGA, Inc. Chicago, IL:
IGA Longhorn Style Colby Cheese, Net Wt. 13 ounces, Sell by
5-27-94, 5-30-94, and 5-31-94
IGA Brick Cheese, Net Wt. 13 ounces, Sell by 5-29-94
IGA Colby Longhorn Style Cheese, Net Wt. 16 ounces, Sell by
5-29-94
Cheese Products distributed by Fry's Food Stores of Arizona,
Inc., Phoenix, AZ
Fry's Longhorn Style Colby Cheese, Net Wt. 16 ounces, Sell
by MAY 30 94R
Fry's Monterey Jack Cheese, Net Wt. 8 ounces, Sell by JUN 3
94R Fry's Longhorn Style Colby Cheese, Net Wt. 8 ounces,
Sell by MAY 30 94R
Fry's Colby Cheese, Net Wt. 24 ounces, Sell by MAY 27 94R
and MAY 29 94R
Fry's Natural Longhorn Style Colby Cheese, Net Wt. 13
ounces, Sell by MAY 27 94R and MAY 30 94
Fry's Natural Monterey Jack Cheese, Net Wt. 15 ounces, Sell
by MAY 29 94R
Cheese Products distributed by Fleming Companies, Inc.,
Oklahoma City, OK
True Value Monterey Jack Natural Cheese, Net Wt. 13 ounces,
Sell by 6-3-94
True Value Colby Cheese Hunk, Net Wt. 24 ounces, Sell by
5-27-94 and 5-29-94
True Value Longhorn Colby Natural Cheese, Net Wt. 13 ounces,
Sell by 5-30-94 and 6-4-94
True Value Longhorn Style Colby Natural Cheese, Net Wt. 22
ounces, Sell by 6-6-94
True Value Colby Longhorn Style Natural Cheese, Net Wt. 10
ounces, Sell by 5-27-94 and 5-28-94
True Value Colby Longhorn Style Natural Cheese, Net Wt. 16
ounces, Sell by 5-30-94
Cheese Products distributed by King Soopers, Inc., Denver,
CO:
King Soopers Longhorn Style Colby Cheese, Net Wt. 10 ounces,
Sell by JUN 4 94
-7- King Soopers Monterey Jack Cheese, Net Wt. 15 ounces, Sell
by JUN 3 94R
King Soopers Longhorn Style Colby Cheese, Net Wt. 15 ounces,
Sell by MAY 30 94R
King Soopers Longhorn Style Colby Cheese, Net Wt. 8 ounces,
Sell by MAY 27 94R
King Soopers Colby Cheese, Net Wt. 24 ounces, Sell by MAY 23
94R, MAY 29 94R, and JUN 3 94R
King Soopers Shredded Monterey Jack Cheese, Net Wt. 8
ounces, Sell by MAY 30 94R and JUN 3 94R
Cheese products distributed by Sunfresh Inc., West Seneca,
NY:
National Longhorn Style Colby Cheese, Net Wt. 13 ounces,
Sell by 6-4-94
National Brick Cheese, Net Wt. 15 ounces, Sell by 6-3-94
National Monterey Jack Cheese, Net Wt. 8 ounces, Sell by
6-3-94
National Longhorn Style Colby Cheese, Net Wt. 20 ounces,
Sell by 5-30-94 and 6/3/94
National Monterey Jack Natural Shredded Cheese, Net Wt. 6
ounces, Sell by 6-5-94
Cheese distributed by Certified Grocers Midwest, Inc.,
Hodgkins, IL:
Countrys Delight Natural Colby Cheese, Net Wt. 13 ounces,
Sell by 5-31-94
Countrys Delight Natural Longhorn Colby Cheese, Net Wt. 20
Lbs., Sell by 5-31-94
Countrys Delight Natural Sliced Colby Cheese, Net Wt. 20
Lbs., Sell by 5-31-94
Countrys Delight Natural Colby Cheese, Net Wt. 8 ounces,
Sell by 6-03-94
Distributed by the Red Food Stores, Inc., Chattanooga, TN:
Red Food Natural Longhorn Style Colby Cheese, Net Wt. 20
ounces, Sell by 6-03-94
Red Food Natural Longhorn Style Colby Cheese, Net Wt. 15
ounces, Sell by 5-31-94
Red Food Natural Colby Cheese, Net Wt. 32 ounces, Sell by
5-31-94
Distributed by RV Foods Inc., Pensacola, FL:
Real Value Fullmoon Colby Cheese, Net Wt. 22 ounces, Sell by
6-03-94
MANUFACTURER Associated Milk Producers, Inc., Rochester, Minnesota.
RECALLED BY Pace Dairy Foods, Rochester, Minnesota, by letter January 7,
10, 12, and 14, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 121,024 pounds were distributed.
REASON Products are contaminated with pieces of metal.
-8- RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Lemon Pudding in #10 size cans, under the following labels:
Kitchen Green, Autocrat, Clark Blue Label, Coastal Blue,
Code Red, Comsourace, Davis Blue, First Choice, Food
Service, Foxriver Yellow, Frosty Acres, GFS Gold, Globe,
Golbon Green, J P Blue, Keith Red, Kraft Premier, Lasco,
Lone Star, Lucky Boy, MBM/Thank You, Monarach Blue, Nifda,
Nugget Black, Parade, Plee-Zing, Pocahontas, Red & White,
Reinhart, Sysco Classic, Thank You, Thank You (Canadian
Print), Tidewater, White Swan Red. Recall #F-268-4.
CODE Two Line code embossed in can ends: 81212/12463,
81212/52463, 81212/12873, 81212/52873, 81212/62873,
81212/12923, 81212/52923, 81212/13193, 81212/53193.
MANUFACTURER Comstock Michigan Fruit Division, Fennville, Michigan.
RECALLED BY Comstock Michigan Fruit, a division of Curtice Burns Foods,
Inc., Rochester, New York, by Fax December 9, 1993, followed
by telephone. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 14,827 cases (6 cans per case) were distributed; firm
estimates 3,500 cases remain on market.
REASON Product is contaminated with Monascus mold.
_______________
PRODUCT Ben & Jerry's Vanilla Ice Cream, in 1 quart containers.
Recall #F-269-4.
CODE Expiration dates: 9/16/94, 9/17/94, 9/24/94, 10/19/94.
MANUFACTURER Ben & Jerry's Homemade, Inc., Waterbury, Vermont.
RECALLED BY Manufacturer, by telephone November 30, 1993, followed by
letter dated December 1, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION California, Minnesota, New Hampshire.
QUANTITY 27,990 quart containers were distributed.
REASON Product contains undeclared sugar.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
==========================
_______________
PRODUCT Albuterol Sulfate Inhalation Solution, 0.5%, packaged in
0.25 ml and 0.5 ml plastic unit dose tubes, Rx
bronchodilator. Recall #D-108-4.
CODE All lots.
MANUFACTURER Copley Pharmaceutical, Inc., Canton, Massachusetts.
RECALLED BY Xactdose, Inc., South Beloit, Illinois (repacker), by
telephone January 6 and 7, 1994, by letter dated January 7,
1994, and by press release January 7, 1994. Firm-initiated
recall ongoing. See also FDA talk paper T94-5, January 7,
1994.
DISTRIBUTION California, Pennsylvania, Illinois, Alabama, Indiana,
Wisconsin, New Jersey, Oklahoma, Ohio, Florida.
QUANTITY 1,230 cases of 0.5 ml tubes and 318 cases of 0.25 ml tubes
were distributed; firm estimates 25 percent of the product
remains on the market.
-9- REASON Product was repacked from solution manufactured by Copley
Pharmaceutical. All lots are under recall after finding the
presence of Pseudomonas bacteria in some lots.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Hydrochlorothiazide Tablets, 25 mg, a diuretic used in the
treatment of hypertension, in bottles of 100.
Recall #D-122-4.
CODE Lot numbers: 18901 EXP 1/95 (repacked on 12/3/93); 18908
EXP 2/95 (repacked on 12/6/93).
MANUFACTURER Unisource, Inc., (repacker), doing business as Omega
Laboratories, Inc., Mobile, Alabama.
RECALLED BY Manufacturer, by telephone January 26, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION North Carolina, California, Delaware.
QUANTITY 181 bottles were distributed.
REASON Some repacked bottles labeled Hydrochlorothiazide Tablets,
25 mg, contained Hydroxyzine HCl Tablets, 25 mg.
_______________
PRODUCT Novolin L-Lente Human Insulin Zinc Suspension (Recombinant
DNA origin), 100 units/ml, 10 ml pial, for use as injection.
Recall #D-125-4.
CODE Lot #2D54092 EXP 4/95.
MANUFACTURER Novo Nordisk A/S, Bagsvaerd, Denmark.
RECALLED BY Novo Nordisk Pharmaceuticals, Inc., Princeton, New Jersey,
by letter dated October 15, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 111,600 vials were distributed; firm estimates fewer than
5,000 vials remain on the market.
REASON Some vials demonstrated clumping of suspension.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Senna-Tab Tablets (Natural Vegetable Laxative) Standardized
Senna Concentrate, a nonprescription product.
Recall #D-123-4
CODE Lot #208113 EXP 9/94.
MANUFACTURER Able Laboratories, Inc. S. Plainfield, New Jersey.
RECALLED BY Manufacturer, by letter dated October 29, 1993. Firm-
initiated recall complete.
DISTRIBUTION New York, Illinois, Nebraska, Ohio, Canada.
QUANTITY 2,440,000 tablets were distributed; firm estimates 1,500,000
tablets remain on the market.
REASON Subpotency.
-10- _______________
PRODUCT Rite-Aid brand Aspirin, regular strength aspirin with
antacid for pain relief, in bottles of 100, nonprescription.
Recall #D-124-4.
CODE Lot numbers: 109150 EXP 9/93, 209001A EXP 3/4, 210167A EXP
10/94.
MANUFACTURER Able Laboratories, Inc., S. Plainfield, New Jersey.
RECALLED BY Manufacturer, by letter dated September 13, 1993, followed
by fax and telephone. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 4,338 bottles were distributed.
REASON Subpotency.
_______________
PRODUCT Transderm Scop (scopolamine 1.5 mg) Transdermal Therapeutic
System, Rx product for the prevention of nausea and vomiting
associated with motion sickness in adults. Recall #D-126-4.
CODE Lot numbers: 1M009951 EXP 3/94, 1M009952 EXP 5/94, 1M010415
EXP 5/95, 1M010511 EXP 12/95, 1M010564 EXP 1/96, 1M010547
EXP 12/94, 1M010549 EXP 3/96.
MANUFACTURER Ciba-Geigy Pharmaceuticals Division, Summit, New Jersey.
RECALLED BY Ciba consumer Pharmaceuticals, Woodbridge, New Jersey, by
letter dated December 1, 1993. Firm-initiated recall
complete.
DISTRIBUTION Lots 1M009951, 1M009952, 1M010415, 1M010511, 1M010564
(distributed nationwide) Lots 1M010547, 1M010549 were
distributed to Germany and Scandinavia respectively).
QUANTITY 467,334 cartons (4 discs per carton) were distributed; firm
estimate 69,369 cartons remain on the market.
REASON Presence of ingredient crystal formation which may result in
subpotency.
_______________
PRODUCT Sinubid Extended Release Tablets, in bottles of 30, Rx oral
analgesic/decongestant/antihistamine for symptomatic relief
of sinusitis. Recall #D-127-4.
CODE Lot #1084126, 1126052, 1262080, 1277029.
MANUFACTURER Parke-Davis Division, Warner-Lambert Company, Morris Plains,
New Jersey.
RECALLED BY Allscrips Pharmaceuticals, Inc., Vernon Hills, Illinois
(repacker), by letter December 7, 1992, and February 26,
1993. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 94 bottles were distributed.
REASON Product does not meet dissolution specifications through
expiration date.
_______________
PRODUCT Clorpactin WCS-90 Bactericide, Virucide, Fungicide and
Sporicide, in packages consisting of 5 2-gm glass bottles,
nonprescription, used to irrigate infected wounds. Recall
#D-12804.
-11- CODE Lot #WC 2190A EXP 2/96.
MANUFACTURER Guardian Labs., Division United of Gardian Inc., Hauppauge,
New York.
RECALLED BY Manufacturer, by letter January 20, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,129 units were distributed; firm estimates none remains on
the market.
REASON Some units declare an incorrect expiration date of 2/92
instead of 2/96.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Platelet Concentrate. Recall #B-133-4.
CODE Unit #479184.
MANUFACTURER Community Blood Center (CBC), Dayton, Ohio.
RECALLED BY Manufacturer, by telephone March 28, 1993. Firm-initiated
recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit.
REASON Unlicensed blood product was distributed interstate.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT I.V. Administration Sets with Control-A-Flo Regulator
Component:
(a) Product Code 2C7590, Baxter Control-A-Flo
Regulator Extension Set with Injection Site, 46 cm (18")
Long;
(b) Product Code 2C7591, Baxter Control-A-Flo
Regulator Extension Set with Injection Site and Luer Lock
Adapter, 46 cm (18") Long;
(c) Product Code 2C7592, Baxter Basic Solution Set with
Control-A-Flo Regulator, Injection Site and Luer Lock
Adapter, 60 Drops/ml, 2.5 m (100") Long;
(d) Product Code 2C7593, Baxter Continu-Flo Solution Set
with Control-A-Flo Regulator, 2 Injection Sites and Luer
Lock Adapter, 60 Drops/ml, 2.5 m (100") Long;
(e) Product Code 2C7594, Baxter Basic Solution Set with
Control-A-Flo Regulator, 2 Injection Sites and Luer Lock
Adapter, 10 Drops/ml, 2.5 m (100") Long;
(f) Product Code 2C7595, Baxter Continu-Flo Solution Set
with Control-A-Flo Regulator, 2 Injection Sites and Luer
Lock, 10 Drops/ml, 2.5 m (100") Long;
(g) Product Code 1C8172, Baxter Basic Solution Set with
Control-A-Flo Regulator and Luer Lock Adapter, 60 Drops/ml,
2.2 m (86") Long;
(h) Product Code 1C8317, Baxter Continue-Flo Solution Set
with Control-A-lo Regulator, 2 Injection Sites and Luer Lock
Adapter, 10 Drops/ml, 2.5 m (97") Long;
-12- (i) Product Code 1C8331, Baxter Continue-Flo Solution Set
with Control-A-Flo Regulator, 3 Injection Sites and Luer
Lock Adapter, 10 Drops/ml, 2.6 m (104") Long;
(j) Product Code 1C8349, Baxter Basic Solution Set with
Control-A-Flo Regulator, Check Valve and Luer Lock Adapter,
60 Drops/ml, 2.4 m (93") Long;
(k) Product Code 1C8354, Baxter InterLink System Basic
Solution Set with Control-A-Flo Regulator, Injection Site
and Luer Lock Adapter, 60 Drops/ml, 2.2 m (87") Long;
(l) Product Code 2C6890, Baxter InterLink System Extension
Set with Control-A-Flo Regulator and Injection Site, 46 cm
(18") Long;
(m) Product Code 2C6891, Baxter InterLink System
Extension Set with Control-A-Flo Regulator, Injection Site
and Luer Lock Adapters, 46 cm (18") Long;
(n) Product Code 2C6895, Baxter InterLink System
Continu-Flo Solution Set with Control-A-Flo Regulator, 2
Injection Sites and Luer Lock Adapter, 10 Drops/ml, 2.5 m
(100") Long. Recall #Z-790-803-3.
CODE All lots.
MANUFACTURER Baxter Healthcare Corporation, Cleveland, Mississippi; and
Baxter Healthcare Corporation, Aibonito, Puerto Rico.
RECALLED BY Baxter Healthcare Corporation, Round Lake, Illinois, by
letters dated August 10, 1993 and September 2, 1993. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 2,331,604 sets were distributed.
REASON A possible fold in the diaphragm within the Control-A-Flo
Regulator resulting in unexplained "free-flow" incidents.
_______________
PRODUCT Night Vision Image Intensifiers, Model T3C-2 and Model T3C-
3, used for viewing objects and persons in subdued lighting.
Recall #Z-210/211-4.
CODE Models T3C-2 and T3C-3.
MANUFACTURER Beach Trading Corporation, Virginia Beach, Virginia.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan December 15, 1993. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 235 units.
REASON Products emitted x-radiation that is unnecessary to the
accomplishment of the purpose of the product and creates a
risk of injury to users.
-13-
END OF ENFORCEMENT REPORT FOR FEBRUARY 16, 1994. BLANK PAGES MAY
FOLLOW.
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