FDA

Enforcement Report

July 8, 1998                                     
98-27


RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS
II

 

PRODUCT

Kellogg's Rice Krispies Treats Cereal, in 14.8 ounce boxes, a
cold cereal product.  Recall #F-528-8.

CODE

Boxes bearing a "Better If Used Before" date code of "Sep
17,1998RC" on boxtop.

MANUFACTURER

Roskam Baking Company, Kentwood, Michigan.

RECALLED BY

Kellogg USA, Battle Creek, Michigan, by telephone or visit
beginning on April 7, 1998.  Firm-initiated recall complete.

DISTRIBUTION

Nationwide.

QUANTITY

48,942 cartons were distributed.

REASON

Product contains undeclared whole oats, whole grain wheat,
almonds and nonfat dry milk.



PRODUCT

Assorted Mini-Quiches and Cheese Blintzes:
a) Country French Style Quiche (flavored with bacon, less
than 2%), Net Wt 0.8 oz., 100 - 0.8 oz. pieces, Hof Foods, Inc.,
Goshen, NY (item #HF183C)
b) Combination Quiche 50s (20 mushroom, 15 spinach, 15
smoked salmon), Net Wt. 48 oz. (3 lbs.), Barney's Foods, Inc.,
Goshen, NY (item #BS370)
c) Assorted Mini Quiches (country french, Monterey,
spinach), Net Wt. 80 oz. (5 lbs.), Town and Country, Goshen, NY
(item #TC176C) and Four Seasons brand, packed exclusively for
International Market Brands, Inc., Cleveland, Ohio (item #FS176C)
d) 40 Cocktail Quiches (country french style Wilton Foods
Inc., Goshen, NY (item #WD132), Net Wt. 30 oz. (1 lb. 14 oz.).
e) Cheese Blintzes with four different packaging
configurations as follows:  (1) Imperial brand, Sysco
Corporation, Houston, Texas (item #2287639), 144, 2.2 oz., Crepe
Blintz Cheese, Net Wt. 19.5 lbs; (2) Sysco brand, Sysco
Corporation, Houston, Texas (item #2287555), 128, 3 oz., Crepe
Cheese Blintz, Net Wt. 24 lbs; (3) Four Seasons Brand, packed
exclusively for International Market Brands, Inc., Cleveland,
Ohio (item #IB510FS), 12 Cheese Blintzes, Net Wt. 26 oz.,(1 lb.,
10 oz.); (4) Wilton Foods Inc., Goshen, NY (item #IB510), 12
cheese blintzes, Net Wt. 26 oz., (1 lb., 10 oz.).  
Recall #F-530/534-8.

CODE

Assorted mini quiches lot #s 29D8, 22D8, 23D8, 0224 & 0304 and
cheese blintzes lot #s 23D8 & 0234.

MANUFACTURER

Wilton Foods, Inc., Goshen, New York.

RECALLED BY

Manufacturer, by letter faxed and mailed on May 1, 1998, and by
telephone on May 4, 1998.  Firm-initiated recall ongoing.

DISTRIBUTION

California, Connecticut, Florida, Illinois, Maryland,
Massachusetts, Missouri, New Jersey, New York, Pennsylvania.

QUANTITY

232 cases of assorted mini quiches and 659 cases of cheese
blintzes were distributed.

REASON

Products were manufactured using an ingredient, liquid
pasteurized eggs, which was found contaminated with
salmonella.



PRODUCT

Spartan brand Blackeye Peas, dry, in 16 ounce bags.  
Recall #F-535-8.

CODE

9SEP98L.

MANUFACTURER

Arrow Industries, Carrollton, Texas.

RECALLED BY

Spartan Stores, Inc., Grand Rapids, Michigan, by letter on
December 18, 1997, and by publishing a notice in the weekly store
bulletin.  Firm-initiated recall complete.

DISTRIBUTION

Indiana, Michigan, Ohio.

QUANTITY

1,272 16-ounce bags were distributed.

REASON

Product contains a lindane pesticide residue greater than FDA's
0.5 ppm action level.



PRODUCT

Special Rye Hamburger and Wiener Buns, wrapped in clear
cellophane wrapper, net weight 1 pound, under the Irene's Bakery
label.  Recall #F-536-8.

CODE

None.

MANUFACTURER

Irene's Health Bakery, Inc., Garretsville, Ohio.

RECALLED BY

Manufacturer, by telephone on June 12 and 15, 1998, followed by
letter mailed on June 15, 1998.  Firm-initiated recall
ongoing.

DISTRIBUTION

Ohio, West Virginia, Indiana, Illinois.

QUANTITY

205 1-pound packages were distributed.

REASON

Product contains undeclared wheat flour.



RECALLS AND FIELD CORRECTIONS:  DRUGS
-- CLASS II

PRODUCT

Norethin 1/35E Oral Contraceptive Tablets, 28 days (Norethindrone
img/Ethinyl estradiol 35 mcg), packaged in 6 dispensers/box.  
NDC #54092-0071-28.  Recall #D-186-8.

CODE

Lot #4J001 EXP 07097.

MANUFACTURER

Searle & Company, Caguas, Puerto Rico.

RECALLED BY

McKesson Drug Company, Landover, Maryland, by telephone on June 1
and 2, 1998.  Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide.

QUANTITY

Undetermined.

REASON

Product was distributed after expiration date.



RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS
III

PRODUCT

Phenylthistine DH Elixir (Pseudoephedrine Hydrochloride 30
mg/Codeine Phosphate 10 mg/Chlorpheniramine Maleate 2 mg), in 4
and 16 fluid ounce amber colored plastic bottles, Rx, under the
Qualitest and Vintage brand labels.  NDC #0254-9359-53 & 
NDC 0603-1520-54 (4 oz.) NDC #0254-9359-58 & NDC #0603-1520-58
(16 oz.).  Recall #D-164-8.

CODE

Lot numbers:  013J6C, 013J6A, 013J6D, 013J6B.

MANUFACTURER

Vintage Pharmaceuticals, Inc., Huntsville, Alabama.

RECALLED BY

Manufacturer, by letter dated May 7, 1998, followed by telephone. 
Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide.

QUANTITY

4,001 (4 oz.) and 4,224 (16 oz) bottles under the Qualitest
label; 2,140 (4 oz.) and 1,932 (16-oz.) bottles under the Vintage
label were distributed.

REASON

Subpotency - Codeine Phosphate (12 month stability testing).



PRODUCT

a) Hydrocortisone Cream, USP 1%, in one pound jars; b)
Hydrocortisone Cream, USP, 2.5%, in 1 pound jars, Rx topical
corticosteroid.  Recall #D-180/181-8.

CODE

Lot numbers:  a) 6K733; b) 6H495.

MANUFACTURER

NMC Laboratories, Glendale, New York.

RECALLED BY

Alpharma U.S. Pharmaceuticals Division, Lincolnton, North
Carolina, by letter dated April 3, 1998.  Firm-initiated recall
ongoing.

DISTRIBUTION

Nationwide.

QUANTITY

Approximately 5,930 units were distributed; firm estimates that
less than 200 units of Hydrocortisone Cream USP 1% and 2.5%
remain on the market.

REASON

Superpotent (12 & 18 month stability).
 


PRODUCT

Adult Low Strength Enteric Aspirin Tablets, 81 mg, OTC, in 120
and 500 tablet bottles, under the following labels:  Fay's,
Goldline, Medicine Shoppe, Leader, and Fedco.  Recall
#D-187-8.

CODE

Fay's - Lot No. 6102858, 6103635, 7016164
Goldline - Lot No. 6102662, 6114047
Medicine Shoppe - Lot No. 6103519, 6114327, 6114424
Leader - Lot No. 6103654; Fedco - Lot No. 6103658.

MANUFACTURER

Granutec, Inc., Wilson, North Carolina.

RECALLED BY

Manufacturer, by telephone on May 20, 1998, and by letters mailed
and faxed on May 22, 1998.  Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide.

QUANTITY

82,104 120-count bottles and 4,326 500-count bottles were
distributed.

REASON

Lack of assurance product will meet potency throughout labeled
expiration date (assay/free salicylic acid).



PRODUCT

Aspirin Tablets, 325 mg, in 100, 250, 500 tablet bottles; under
the  Family Pharmacy and Equate brand labels.  Recall
#D-188-8.

CODE

Equate - Lot No. 7062265, 7062266, 7062267, 7062268, 7062269
Family Pharmacy - Lot No. 7072695, 7072692.

MANUFACTURER

Time Caps, Inc., Farmingdale, New York (contract
manufacturer).

RECALLED BY

Granutec Inc., Wilson, North Carolina, by letters faxed and
mailed on May 27, 1998.  Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide.

QUANTITY

101,910 100-count bottles, 5,886 500-count bottles and 46,596
250-count bottles were distributed.

REASON

Failure to meet dissolution specifications.



PRODUCT

Ascorbic Acid Injection, USP, 500 mg/2mL, in amber glass ampules,
Rx, intended for intramuscular, intravenous or subcutaneous
administration, under the Schein label.  NDC #0364-2361-42.
Recall #D-189-8.

CODE

Lot numbers:  96J570 EXP 8/98 and 96L790 EXP 10/98.

MANUFACTURER

Steris Laboratories, Inc., Phoenix, Arizona.

RECALLED BY

Manufacturer, by letter on June 12, 1998.  Firm-initiated recall
ongoing.

DISTRIBUTION

Nationwide.

QUANTITY

143,750 bottles of lot 96J570 and 139,975 bottles of lot 96L790
were distributed.

REASON

Inconsistent physical appearance (color specification).



PRODUCT

Laura Lynn Ultra Concentrated Dishwashing Detergent and
Anti-Bacterial Hand Soap (Tricolsan), packaged in 28 fluid ounce
bottles, intended for residential use only, and is not for
medical use.  Recall #D-190-8.

CODE

All lot codes.

MANUFACTURER

Huish Detergents, Inc., Bowling Green, Kentucky.

RECALLED BY

Manufacturer, by telephone on June 8, 1998, followed by verbal
communication and letter mailed on June 10, 1998.  Firm-initiated
recall ongoing.

DISTRIBUTION

Nationwide.

QUANTITY

701 cases (8,412 bottles) were distributed.

REASON

Misbranding - Product fails to declare active ingredient.



RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS
II
 

PRODUCT

Fresh Frozen Plasma.  Recall #B-837-8.

CODE

Unit numbers:  49G69000 and 49G69008.

MANUFACTURER

American Red Cross Blood Services, Harlingen, Texas.

RECALLED BY

American Red Cross Blood Services, Tulsa, Oklahoma, by telephone
on December 22, 1997, and by letter dated December 23, 1997. 
Firm-initiated recall complete.

DISTRIBUTION

Texas.

QUANTITY

2 units were distributed.

REASON

Blood products were labeled with an extended expiration date.



PRODUCT

a) Red Blood Cells; b) Recovered Plasma.  Recall #B-844/845-8.

CODE

Unit #29FE95393.

MANUFACTURER

American Red Cross Blood Services, Norfolk, Virginia.

RECALLED BY

Manufacturer, by letter dated April 1, 1998.  Firm-initiated
recall complete.

DISTRIBUTION

Virginia.

QUANTITY

1 unit of each component was distributed.

REASON

Blood product was collected from a donor with a history of
cancer.



PRODUCT

a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma.
Recall #B-1177/1179-8.

CODE

Unit #42W90702.

MANUFACTURER

American Red Cross Blood Services, Cleveland, Ohio.

RECALLED BY

Manufacturer, by letter dated March 10, 1998.  Firm-initiated
recall complete.

DISTRIBUTION

Ohio.

QUANTITY

1 unit of each component was distributed.

REASON

Blood products were collected from a donor taking the drug
Purinethol for Crohn's disease.



PRODUCT

Red Blood Cells.  Recall #B-1256-8.

CODE

Unit #5067485.

MANUFACTURER

LifeSource, Glenview, Illinois.

RECALLED BY

Manufacturer, by telephone on March 13, 1998.  Firm-initiated
recall complete.

DISTRIBUTION

Illinois.

QUANTITY

1 unit was distributed.

REASON

Blood product was collected from a donor whose donor history
screening was incomplete.




PRODUCT

a) Red Blood Cells; b) Platelets.  Recall #B-1281/1282-8.

CODE

Unit #4S5475.

MANUFACTURER

Puget Sound Blood Center & Program, Seattle, Washington.

RECALLED BY

Manufacturer, by letter dated February 18, 1998, and by telephone
on June 3, 1998.  Firm-initiated recall complete.

DISTRIBUTION

Washington state.

QUANTITY

1 unit of each component was distributed.

REASON

Blood products were not quarantined after receiving post donation
information regarding close contact with a person with chronic
Hepatitis C.



PRODUCT

Platelets.  Recall #B-1283-8.

CODE

Unit #06FG8317.

MANUFACTURER

American Red Cross, Los Angeles, California.

RECALLED BY

Manufacturer, by telephone on January 20, 1998, and by letter
dated January 23, 1998.  Firm-initiated recall complete.

DISTRIBUTION

California.

QUANTITY

1 unit was distributed.

REASON

Platelets were prepared from a unit collected from a donor who
had taken aspirin within 72 hours of donation.



PRODUCT

a) Red Blood Cells; b) Fresh Frozen Plasma.  
Recall #B-1284/1285-8.

CODE

Unit #06LX24529.

MANUFACTURER

American Red Cross, Los Angeles, California.

RECALLED BY

Manufacturer, by letter dated October 21, 1997.  Firm-initiated
recall complete.

DISTRIBUTION

California.

QUANTITY

1 unit of each component was distributed.

REASON

Blood products were collected from a donor taking the drug
Famvir.



PRODUCT

Red Blood Cells.  Recall #B-1286-8.

CODE

Unit #06GN03214.

MANUFACTURER

American Red Cross, Los Angeles, California.

RECALLED BY

Manufacturer, by letters dated November 24, 1997, and December
24, 1997.  Firm-initiated recall complete.

DISTRIBUTION

California.

QUANTITY

1 unit was distributed.

REASON

Blood product was collected from a donor taking the drug
Methotrexate.




PRODUCT

Red Blood Cells.  Recall #B-1287-8.

CODE

Unit #06LC38302.

MANUFACTURER

American Red Cross, Los Angeles, California.

RECALLED BY

Manufacturer, by telephone on November 3, 1997.  Firm-initiated
recall complete.

DISTRIBUTION

California.

QUANTITY

1 unit was distributed.

REASON

Blood product was collected from a donor who had no hemoglobin
check recorded during screening.



PRODUCT

a) Red Blood Cells; b) Cryopredipitated AHF; c) Recovered Plasma;
d) Platelets, For Use In Manufacturing Noninjectable Products. 
Recall #B-1288/1291-8.

CODE

Unit numbers:  a) 06GK35392, 06GH29245; b) 06GK35392; c)
06GK35392, 06GH29245; d) 06GH29245.

MANUFACTURER

American Red Cross, Los Angeles, California.

RECALLED BY

Manufacturer, by letters dated December 3, 1997, and January 5,
1998.  Firm-initiated recall complete.

DISTRIBUTION

California, Massachusetts, Switzerland.

QUANTITY

a) 2 units; b) 1 unit; c) 2 units; d) 1 unit was distributed.

REASON

Blood products, collected from a donor with a history of
cancer.



PRODUCT

Source Plasma.  Recall #B-1297-8.

CODE

Unit numbers:  LP77433, LP77229, LP77022, LP76823, LP76598.

MANUFACTURER

Interstate Blood Bank, Inc. of Missouri, St. Louis, Missouri.

RECALLED BY

Manufacturer, by letter dated July 2, 1997.  Firm-initiated
recall complete.

DISTRIBUTION

New Jersey and Germany.

QUANTITY

5 units were distributed.

REASON

Failure to quarantine blood products after discovering 
that the donor had enlarged lymph nodes.



RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS
III
 

PRODUCT

a) Red Blood Cells; b) Recovered Plasma.  Recall
#B-1164/1165-8.

CODE

Unit #32KH62641.

MANUFACTURER

American Red Cross Blood Services, Madison, Wisconsin.

RECALLED BY

Manufacturer, by letters dated March 4 and 11, 1998. 
Firm-initiated recall complete.

DISTRIBUTION

Maryland and Switzerland.

QUANTITY

1 unit of each component was distributed.

REASON

Blood products were collected from a donor whose health history
screening was not adequately performed.



UPDATE

American Red Cross Blood Services, St. Louis, Missouri, recall of
Red Blood Cells, Recall #B-1224-8, which appeared in the June 24,
1998 Enforcement Report is a Class III recall.



RECALLS AND FIELD CORRECTIONS: 
DEVICES -- CLASS II

PRODUCT

Shampaine Series 5100 Surgical Tables, designed for use in major
surgical suites, ambulatory theaters and medical operatories
where accurate patient positioning is critical:
a) Model 5100B (Battery/Electrical operated);
b) Model 5100E (Electrical operated only).  Recall
#Z-636/637-8.

CODE

Shampaine 5100 B:  RN9508001/RN9508003; RN9508005/RN9508010;
RN9509001/RN9509015; RN9510001/RN9510023; RN9511001/RN9511020;
RN9512001/RN9512020; RN9601001/RN9601013; RN9602001/RN9602019;
RN9605001/RN9605018; RN9606001/RN9606015; RN9608001/RN9608012;
RN9609001/RN9609015; RN9610001/RN9610020; RN9611001/RN9611016;
RN9612001/RN9612002; RN9612004/RN9612007; RN9612009;
RN9612011/RN9612012; RN9612014; RN9701003/RN9701012;
RN9701018/RN9701027; RN9702001/RN9702014; RN9702019/RN9702024;
RN9703001/RN9703014; RN9703018/RN9703020; RN9704001/RN9704022;
RN9704028/RN9704033; RN9705001/RN9705011; RN9705015/RN9705018;
RN9705022/RN9705031; RN9707001/RN9707017; RN9707020;
RN9708013/RN9708025; RN9709018/RN9709037; RN9710009/RN9710033;
RN9711009/RN9711030; RN9712010/RN9712027; RN9801009/RN9801013;
RN9802009/RN9802028; RN9803001/RN9803020
Shampaine 5100 E:  RP9602001; RP9612010; RP9612013;
RP9703015/RP9703017; RP9705012/RP9705014; RP9707018, RP9707019;
RP9709038/RP9709040.

MANUFACTURER

Gettinge/Castle, Inc., N. Charleston, South Carolina.

RECALLED BY

Manufacturer, by letter on or about March 27, 1998. 
Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide and international.

QUANTITY

a) 473 units; b) 14 units were distributed.

REASON

In certain situations the current software may allow the patients
head to momentarily travel below level.



PRODUCT

a) PDS-II Violet Monofilament Suture, 27 inch, size 0, for
general closure, packaged in a 5-up primary foil strip (sold
separately); b) E-Pack Procedure Kits (containing PDS-II Suture
package).  Recall #Z-638/639-8.

CODE

Suture packages:  Product Code Z-340, Lot KP9255  
E-Pack Procedure Kits:  Product codes  2767E, 3475E, 4489E,
4620E, 4739E, 4764E, 4917E, 4959E, 4990E, 5071E, 5072E,
5087E, 5235E, 5270E, 5363E, 5375E, 5384E, 5385E, 5487E,
E801, E966.

MANUFACTURER

Ethicon, Inc., San Angelo, Texas.

RECALLED BY

Ethicon, Inc., Somerville, New Jersey, by letter on June 10,
1998.  Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide and Canada.

QUANTITY

3,076 sutures (11,080 distributed in 5-up strips and 1,996
distributed  in E-PACK procedure kits.

REASON

The primary foil package seals were defective, thereby
compromising the sterility of the device.



PRODUCT

Abiomed Bi-Ventricular Support System.  The device provides
ventricular assist and restores hemodynamics in patients
suffering severe cardiac dysfunction:

a) Abiomed BVS 5000 Bi-Ventricular Support System -   Standard
Flow, Serial Nos. 1199-1339 (not including 1238), 1341, and 1343; 
b) Abiomed BVS 5000I Bi-Ventricular Support System - Increased
Flow, Serial Nos. 1500-1542, not including 1526, 1528, 1529,
1537.  Recall #Z-640/641-8.

CODE

a) Serial Nos. 1199-1339 (not including 1238), 1341, and 1343; 
b) Serial Nos. 1500-1542, not including 1526, 1528, 1529,
1537.

MANUFACTURER

Abiomed, Inc., Danvers, Massachusetts.

RECALLED BY

Manufacturer, by letter faxed on May 4, 1998, and by overnight
mail on May 7, 1998.  Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide and international.

QUANTITY

181 consols were distributed.

REASON

Some consoles have problems with the AC/DC converter.  When there 
is a failure of this component, the console will not operate on
normal AC mains power.  However, the console will switch over
automatically to internal battery operation, allowing a period of
time to obtain a backup console.



RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS
III

PRODUCT

ESA Metexchange Reagents Kit for Blood Lead Analysis.
Recall #Z-048-8.

CODE

Catalog #45-0010, Lot #A9803-06.

MANUFACTURER

ESA, Inc., Chelmsford, Massachusetts.

RECALLED BY

Manufacturer, by telephone on May 27, 1998.  Firm-initiated
recall ongoing.

DISTRIBUTION

California, Florida, Georgia, Kansas, Illinois, Louisiana,
Massachusetts, Minnesota, Missouri, Ohio, Nebraska, New
Hampshire, New York.

QUANTITY

181 kits were distributed.

REASON

The incorrect lead value was assigned to the Lo Calibrator.



END OF ENFORCEMENT REPORT FOR JULY 10, 1998.  BLANK PAGES MAY
FOLLOW.


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