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.
January 21, 1998 98-03
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============
PRODUCT Ferrous Fumarate, used for further
manufacture, e.g. chewable children's
multivitamins, pre-natal vitamins, and sports
foods: a) Descote Ferrous Fumarate 60%;
b) Destab Ferrous Fumarate 90S.
Recall #F-222/223-8.
CODE a) PD1312 b) J111-7.
MANUFACTURER a) Particle Dynamics, Inc., St. Louis,
Missouri; b) International Food Processors,
Hayfield, Minnesota.
RECALLED BY Particle Dynamics, Inc., St. Louis, Missouri,
by telephone on June 27, 1997, followed by
letter faxed on July 3, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION New Jersey, Oklahoma, Maryland, New York,
South Carolina, Michigan, California, Utah,
Pennsylvania, Florida, international; b)
California, New Jersey, Texas, North Carolina.
QUANTITY a) 5,690 kilograms; b) 3,150 kilograms were
distributed.
REASON Product contains excessive levels of lead.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Tang San brand Hard Ground Nut Candy, in 8
ounce plastic bags. Recall #F-185-8.
CODE None. Any product which does not specifically
list peanut as an ingredient.
MANUFACTURER Tien Yun Corporation, Taiwan (packer).
RECALLED BY Summit Import Corporation, New York, New York,
by letter dated September 25, 1997. Completed
recall resulted sample analysis and follow-up
by the New York State Department of
Agriculture and Markets.
DISTRIBUTION New York, Illinois, Virginia, Missouri,
Maryland, Florida.
QUANTITY 42 cases (50 bags per case) were distributed.
REASON The product's ingredient statement lists only
"nut", but does not specify what nut is in the
product.
_______________
PRODUCT Seneca Apple Juice in PET containers, 46 and,
64 ounce containers. Recall #F-221-8.
CODE 46 oz. containers "HVMP" production date
8/18/97 - 64 oz. containers "H6MP" production
date 8/28/97 - "JJMP" production date 9/08/97.
MANUFACTURER Seneca Foods Corporation, Prosser, Washington.
RECALLED BY Seneca Foods Corporation, Marion, New York, by
letters faxed and mailed on November 24 and
25, 1997. Firm-initaited recall ongoing.
DISTRIBUTION Washington state, Oregon, Montana, California,
and Costa Rica.
QUANTITY Code H6MV - 6059 cases/8 containers
Code JJMV - 6192 cases/8 containers
Code HVMP - 4833 cases/8 containers
17,084 cases total were
distributed.
REASON The product is unfit for food due to off
flavor.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS
I =============
_______________
PRODUCT Glycyrrhizic Acid (extract) Injection, 8 mg,
30mL vials, Rx. Recall #D-062-8.
CODE All product purchased from April 1, 1996 thru
October 10, 1996.
MANUFACTURER Apothe'Cure, Inc., Dallas, Texas.
RECALLED BY Manufacturer, by letter on November 25, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 257 vials were distributed.
REASON Microbial contamination - Mold in
product-aspergillus versicolor.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Polymyxin B Sulfate, USP, (for Prescription
Compounding), 100 million units per bottle, in
bottles of 10.78 grams. Recall #D-059-8.
CODE Lot #7D6013.
MANUFACTURER Repacked for Coulter Foods.
RECALLED BY Paddock Laboratories, Inc., Minneapolis,
Minnesota, by telephone on December 11 and 12,
1997, followed by letter sent on December 12,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, California, Florida, Maryland,
Michigan, Minnesota, New York, Texas.
QUANTITY 25 bottles were distributed.
REASON Mislabeling - Product potency labeled as 9282
polymyxin B units/mg, but actually contains
7891 units/mg.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-442-8.
CODE Unit #21GJ84638.
MANUFACTURER American Red Cross, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated October 30,
1997. Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to a malarial endemic area.
_______________
PRODUCT Red Blood Cells. Recall #B-447-8.
CODE Unit #W48088.
MANUFACTURER Vector Healthsystems, Inc., Providence, Rhode
Island.
RECALLED BY Manufacturer, by letter dated April 10, 1997.
Firm-initiated recall complete.
DISTRIBUTION Rhode Island.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported travel to an area designated as
endemic for malaria.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT a) Red Blood Cells; b)Platelets.
Recall #B-443/444-8.
CODE Unit #KE71065.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by letter dated October 27,
1997. Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
whose hemoglobin/hematocrit was not
determined.
RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II =========
_______________
PRODUCT Tomoscan AV-#1 CT Scanner, used in CT
Radiography. Recall #Z-238-8.
CODE None.
MANUFACTURER Phillips Medical Systems, Shelton,
Connecticut.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan on January 9, 1998.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 21 units were distributed.
REASON The units are defective under 21 CFR 1003.2 in
that they do not interrupt the exposure when
the tabletop movement stops during a volume
scan mode.
_______________
PRODUCT Model No. A3 Beam Limiting Device (BLD) for
the Versaview Model A3 Dental System, used in
dental radiography. Recall #Z-246-8.
CODE None.
MANUFACTURER J. Morita Corporation, Tustin, California.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan January 9, 1998.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 22 units were distributed.
REASON The units are defective under 21 CFR 1010.3
and 1020.30(e) in that they do not proper
certification and identification labels on the
beam limiting device.
_______________
PRODUCT General Radiographic Film:
a) Kodak INSIGHT Thoracic Imaging Film, 35 x
43 cm, Cat. #828 8201, emulsion #s 431 and 432
b) Kodak INSIGHT VHS Thoracic Imaging Film,
35 x 35 cm, Cat. #832 3669, emulsion # 066;
35 x 43 cm, Cat. #173 1165, emulsion #066.
Recall #Z-276/277-8.
CODE emulsion #066, exp. 6/99
emulsion #431, exp. 6/99
emulsion #432, exp. 8/99.
MANUFACTURER Eastman Kodak Company, Windsor, Colorado.
RECALLED BY Eastman Kodak Company, Health Sciences
Division, Rochester, New York, by letters
dated November 26, 1997, and December 2, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,923 packs were distributed.
REASON The product was finished incorrectly,
resulting in a orientation error during
exposure.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III =========
_______________
PRODUCT CDC Anaerobe Laked Sheep Blood Agar with
Kanamycin and Vancomycin, for in-vitro
diagnostic use. Recall #Z-280-8.
CODE Catalog No. 4321846, Lot Nos. G2RPHK, G3RPKT,
G4RPOF, H1RPSK, H2RPWL, H3RPZZ, H4RRCI, and
H5RRHJ.
MANUFACTURER Becton Dickinson Microbiology Systems,
Cockeysville, Maryland.
RECALLED BY Becton Dickinson Microbiology Systems, Sparks,
Maryland, by letter faxed in August 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 106,440 units were distributed.
REASON Product is contaminated with Cryptococcus
albicus.
_______________
PRODUCT CDC Anaerobe 5% Sheep Blood Agar with
Phenylethyl Alcohol, for in-vitro diagnostic
use. Recall #Z-281-8.
CODE Catalog #4321739, Lot #I1RAIA.
MANUFACTURER Becton Dickinson Microbiology Systems,
Cockeysville, Maryland.
RECALLED BY Becton Dickinson Microbiology Systems, Sparks,
Maryland, by telephone and letter faxed on
September 23, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 8,000 units were distributed; firm estimated
that 2,276 units remained on market at time of
recall initiation, however, the product is now
expired.
REASON Product is contaminated with Enterococcus
faecium.
_______________
PRODUCT Trypticase Soy Agar with 5% sheep Blood (TSA
II), for in-vitro diagnostic use.
Recall #Z-282-8.
CODE Catalog No. 4321261, Lot No. I4RAIS.
MANUFACTURER Becton Dickinson Microbiology Systems,
Cockeysville, Maryland.
RECALLED BY Manufacturer, by letter faxed on September 23,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 11,590 units were distributed. Firm estimated
that 48,768 units remained on market at time
of recall initiation, however, the product is
now expired.
REASON Product is contaminated.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS I =================
_______________
PRODUCT Large Volume Parenterals:
Hypertonic Saline Solution 7.2%
Electrolyte Solution with Dextrose Injection
Calcium Gluconate 23%
Dextrose Sol 50%
Calcium Gluconate Injection 23%
Caldex CMPK Injection
Lactated Ringer Solution Injection
Sterile Water for Injection
Vitamin A & D Injection
Vitamin B, D & B12 Injection
Vitamin B Complex Injection
Vitamin B Complex Fortified Injection.
Recall #V-006-8 and V-010/020-8.
CODE All lots.
MANUFACTURER Sierra Pharmaceuticals, Inc., Mexicali,
Mexico.
RECALLED BY Veterinary Pharmaceuticals, Inc., Hanford,
California, by press release dated January 16,
1998. FDA-requested recall ongoing. See also
FDA press release 98-02, dated January 16,
1998.
DISTRIBUTION California, Missouri.
QUANTITY Undetermined.
REASON Products contaminated with Bacillus
cereus - labeling for these products falsely
states they are sterile; common equipment
manufacturing practices and controls were
used; there is no assurance of sterility and
the products are adulterated.
END OF ENFORCEMENT REPORT FOR JANUARY 21, 1997. BLANK PAGES MAY FOLLOW.
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End of Enforcement Report for
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