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
07/22/1992
RECALLS AND FIELD CORRECTIONS: July 22, 1992
FOODS - CLASS I
92-30
PRODUCT Butter and Butterine (60% butter and 40% margarine), various
brands, various weights in portion control sizes in 5 gm
weights, cups in 5 gm portions, continentals (foil wrapped
pieces), in 7-1/2 to 10 gm portions, and reddies (cardboard
bottom/paper hat) in 5 gm portions and two bulk sizes of
butter, 10 pound or 68 pound:
(a) Butter Continentals;
(b) Butter Readies;
(c) Butter Cups;
(d) Whipped Butter Cups;
(e) Unsalted Butter Continentals;
(f) Butterine Readies;
(g) Butterine Continentals;
(h) Butterine Patties;
(i) AA Butter Bulk;
(j) AA Unsalted Butter Bulk;
(k) A Butter Bulk;
(l) Unsalted Butter Bulk;
(m) Butterine Bulk. Recall #F-398/410-2.
Brand names of portion control sizes are as follows:
a. Gilt Edge 47 Cut Continentals
b. Gilt Edge 59 Cut Continentals
c. Margate 47 Cut Continentals
d. Margate 108 Cut Reddies
e. Margate 90 Cut Reddies
f. Margate 90 Ct. Cups
g. Margate 90 Ct. Whip Cups
h. Meadow Gold 90 Cut Reddies
i. Mortenson's 90 Cut Reddies
j. Oak Farms 47 Cut Continentals
k. SS Pierce 59 Cut Continentals
l. Portion Pac 90 Cut Reddies
m. Portion Pac 108 Cut Reddies
n. Portion Pac 72 Ct. Cups
o. Portion Pac 90 Ct. Cups
p. Portion Pac 47 Cut Continentals
q. Portion Pac Unsalted 47 Cut Continentals
r. Portion Pac 59 Cut Continentals
s. Portion Pac 60/40 Cut Reddies
t. Portion Pac 60/40 59 Cut Continentals
u. Portion Pac 60/40 90 Cut Patties
v. SYSCO 47 Cut Continentals
w. SYSCO 59 Cut Continentals
x. Velda Farms 47 Cut Continentals
Bulk descriptions are as follows:
a. 10# AA Bulk
b. 10# AA Unsalted Bulk
c. 10# WIS AA Unsalted Bulk
d. 68# WIS A Bulk
e. 68# WIS AA Bulk
f. 68# WIS AA Unsalted Bulk
g. 68# AA Bulk
h. 68# Margate AA Bulk
i. 68# Margate Unsalted Bulk
j. 68# 60/40 Butterine Bulk
k. 68# Food Service Bulk
CODE All bulk butter manufactured on 1/24-30/92 and 3/18-23/92
(codes 92024 through 92030 and 92078 through 92083. All butter
chips, butter portions and butterine portions made from the
bulk churned on 1/24-30/92 and 3/18-23/92 were recalled.
MANUFACTURER Zander's Creamery, Inc., Cross Plains, Wisconsin.
RECALLED BY Manufacturer, by letters dated March 14, 24, March 27, 1992,
April 14 and 15, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Arizona, California, Florida, Illinois, Maryland,
Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New
Jersey, Ohio, Wisconsin.
QUANTITY Firm estimates that little remains on the market due to rapid
consumption.
REASON Products are contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
PRODUCT Imported (Ecuador) Fresh Headed and Gutted Tuna Fish.
Recall #F-331-2.
CODE Uncoded.
-2-
MANUFACTURER Chamega S.A., Guayaquil, Ecuador.
RECALLED BY E.D.E. International, Inc., Miami, Florida, by letter May 7,
1992. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1,963 pounds were distributed.
REASON Product contains excessive levels of histamine.
PRODUCT Tree Ripe brand Lemonade in 16 ounce cardboard cartons.
Recall #F-421-2.
CODE Sell By 5-25Al, 6-10A1, 6-17A1.
MANUFACTURER Tuscan Dairy Farms, Inc., Union, New Jersey.
RECALLED BY Manufacturer, by letter May 14, 1992. Firm-initiated recall
complete.
DISTRIBUTION Northeastern United States.
QUANTITY 160 cases (42 units per case) were distributed; firm estimates
none remains on the market.
REASON Product contains undeclared FD&C Yellow No. 5.
PRODUCT La Cena Pineapple Syrup, in 24 ounce glass bottles.
Recall #F-422-2.
CODE None.
MANUFACTURER Halcon Baker, Inc., Caguas, Puerto Rico.
RECALLED BY La Cena Fine Foods, Ltd., Saddle Brook, New Jersey, by
telephone on or about September 19, 1991. Firm-initiated
recall ongoing.
DISTRIBUTION New York, New Jersey, Pennsylvania, Massachusetts, Connecticut.
QUANTITY 7,068 bottles were distributed.
REASON Product contains undeclared FD&C Yellow No. 5.
UPDATE Classification for Recall #F-371/392-2, various frozen baked
goods or frozen products used as ingredients in the manufacture
of baked goods, manufactured by Rich Products Corporation,
Buffalo, New York has been changed from Class III to Class II.
This action appeared in the July 15, 1992 Enforcement Report.
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
PRODUCT Herdez brand Mexican Green Sauce, in 7 ounce metal cans, used
as a dip, in tacos, enchiladas, eggs and meats, etc.
Recall #F-395-2.
CODE All lots with codes beginning with K12 through K18.
MANUFACTURER Herdez, S.A. De C.V., Mexico, D.E.
RECALLED BY Festin Food Corporation, Carlsbad, California, by letter April
28, 1992. Firm-initiated recall ongoing.
-3-
DISTRIBUTION Arizona, Arkansas, California, Colorado, Florida, Georgia,
Hawaii, Idaho, Iowa, Illinois, Indiana, Louisiana, Minnesota,
North Carolina, Nevada, New York, Oregon, Texas, Utah,
Virginia, Washington state.
QUANTITY 109,559 cases were distributed. On May 15, 1992 firm estimated
that 500 cases remained on the market.
REASON Product is contained in swollen cans.
PRODUCT Spaghetti Sauce in 6 pound and 10 ounce metal cans, under the
following labels: Cento Spaghetti Sauce, Monarch Spaghetti
Sauce, Nugget Spaghetti Sauce; Nugget Nutri Gold Spaghetti
Sauce No Salt or Sugar Added. Recall #F-396/397-2.
CODE Product codes: 1153 CM12, 1153 C18M, 1153 C19M.
MANUFACTURER DiLullo and Son, Westville, New Jersey, by telephone October 21
& 24, 1991, followed by letter December 27, 1991.
Firm-initiated recall ongoing.
DISTRIBUTION Connecticut, New Jersey, Pennsylvania.
QUANTITY 240 cases were distributed; firm estimated that 29 cases
remained on market at time of recall initiation.
REASON Product is contained in swollen and exploding cans.
PRODUCT Hi-C Fruit Drinks in 46 ounce cans:
(a) Boppin Berry; (b) Cherry; (c) Double Fruit Cooler;
(d) Ecto Cooler; (e) Fruit Juice; (f) Fruity Bubble Gum;
(g) Grape Drink; (h) Hula Cooler Drink; (i) Hula Punch;
(j) Orange Drink; (k) Peach; (l) Wild Berry Drink.
Recall #F-423/434-2.
CODE All lots manufactured from May 25, 1992 through June 5, 1992.
MANUFACTURER Coca-Cola Foods, Hightstown, New Jersey.
RECALLED BY Coca-Cola Foods, Houston, Texas, by visit June 19, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Connecticut, New Jersey, New York, Pennsylvania.
QUANTITY 4,287,800 cases (12 units per case) were distributed.
REASON Product has defective can seams.
RECALLS AND FIELD CORRECTIONS: COSMETICS - CLASS III
PRODUCT So White & Lite Ultra Frosting & Highlighting Bleach, in 1 and
2 pound boxes. Recall #F-226-2.
CODE All lots.
MANUFACTURER Hair Systems, Inc., Englishtown, New Jersey.
RECALLED BY Matrix Essentials, Inc., Solon, Ohio, by telephone and Fax May
5, 1992, followed by letter May 6, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada, United Kingdom, Italy, Australia.
QUANTITY 6,636 1-pound boxes and 13,224 2-pound boxes were distributed.
REASON Heat from product reaction damages the hair and skin.
-4-
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
PRODUCT (a) Magnesium-ATP in glass vials, l00 micromoles/cc, l0 ml
vials, and all other sizes, an injectable product;
(b) Unlabeled clear glass vials containing hydrocortisone
sodium succinate in 30 mg and l0 ml sizes. Includes all sizes
and lot numbers. (Lyophilized product to be reconstituted for
injection). Recall #D-411/412-2.
CODE All lot numbers.
MANUFACTURER For Your Health, Inc., Kent, Washington.
RECALLED BY Manufacturer, by letters dated July 7 or 8, 1992. FDA
requested recall ongoing. (See Press release P92-18, June 19,
1992.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Non-sterility.
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
PRODUCT Various injectable products, lyophilized products to be
reconstituted for injection and Vitamin A & C eyedrops:
(a) Chromium liquid in glass vials, l00 mcg/ml, 100 ml vials,
to include all other sizes and lot numbers. (injectable
product);
(b) Copper liquid in glass vials, 2 mg/ml, l00 ml vials, to
include all other sizes and lot numbers. (injectable product);
(c) Manganese liquid in glass vials, l00 mcg/ml, l00 ml vials,
to include all other sizes and lot numbers. (injectable
product);
(d) Molybdenum in glass vials, l00 mcg/ml, l00 ml vials, to
include all other sizes and lot numbers. (injectable product);
(e) Selenium liquid in glass vials, 200 mcg/ml, l00 ml vials,
to include all other sizes and lot numbers. (injectable
product);
(f) Vanadium liquid in glass vials, 200 mcg/ml, l00 ml vials,
to include all other sizes and lot numbers. (injectable
product);
(g) Zinc liquid in glass vials, l0 mcg/ml, l00 ml vials, to
include all other sizes and lot numbers. (injectable product);
(h) Trace Mineral in glass vials, l00 ml, to include all other
sizes and lot numbers. (injectable product);
(i) Vitamin A & C eyedrops, Liquid (possibly yellow in color)
in plastic eyedrop bottles. The bottles include all sizes and
all lot numbers;
(j) Saline Solution in l00 ml glass vials possibly labeled
"Normal Saline 0.9% NaCl" followed by a batch number. Product
includes all sizes and all lot numbers. (injectable product);
(k) Glutathione in glass vials possibly labeled in part,
"Glutathione 600mg/vial" followed by a lot number and an EXP
-5-
date. Product includes all sizes and lot numbers.
(Lyophilized product to be reconstituted for injection).
Recall #D-413/423-2.
CODE All lot numbers.
MANUFACTURER For Your Health, Inc., Kent, Washington.
RECALLED BY Manufacturer, by letters dated July 7 or 8, 1992. FDA
requested recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Lack of assurance of sterility.
PRODUCT (a) Acetaminophen, 80 mg per 1/2 teaspoon, labeled Children's
Non-aspirin Elixir, Cherry Flavored in 4 fluid ounce bottles
under the following labels: Mediguard, Spectrum, Life Line,
Bi-Mart, Valco, Scolari's, IGA, Basha's, Erickson's, Med-Plus,
Source, Hy-Top;
(b) Acetaminophen, 80 mg per 1/2 teaspoon, labeled Children's
Non-aspirin Elixir, Grape Flavored, in 4 fluid ounce bottles
under the following labels: Mediguard, Med-Plus, Hy-Top;
(c) Acetaminophen, 80 mg per 0.8 ml, labeled Infants
Non-aspirin Drops, Fruit Flavored in 1/2 fluid ounce bottles,
with droppers, under the following labels: Mediguard,
Life-Line, Bi-Mart, Scolari's, Hy-Top. Recall #D-424/425-2.
CODE (a) All lots shipped between October 1, 1991 through February
26, 1992. All products specifically identified with product
number 8351-810-## for Acetaminophen, 80 mg per 1/2 teaspoon,
cherry flavored. "##" designates brand type as follows:
- 01 Mediguard - 16 Basha's
- 02 Spectrum - 31 Erickson's
- 03 Life-Line Pharmaceutical - 44 Med-Plus
- 05 Bi-Mart - 55 Source
- 06 Valco - 60 Mediguard
- 07 Scolari's - 73 Hy-Top
- 13 IGA
(b) All lots shipped between October 1, 1991 through February
26, 1992. All products specifically identified with product
number 8360-810-## for Acetaminophen, 80 mg per 1/2 teaspoon,
grape flavored. "##" designates brand type as follows:
-01 Mediguard
-44 Med-Plus
-73 Hy-Top
(c) All lots shipped between October 1, 1991 through February
26, 1992. All products specifically identified with product
number 7180-802- for Acetaminophen, 80 mg per 0.8 ml, fruit
flavored, "##" designates brand type as follows:
- 01 Mediguard - 07 Scolari's
- 03 Life-Line Pharmaceuticals - 73 Hy-Top
- 05 Bi-Mart.
MANUFACTURER Life-Line Nutritional Products, Inc, Hayward, California.
RECALLED BY Manufacturer, by telephone between February 28, 1992 to March
2, 1992 with a follow letter March 6, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
-6-
QUANTITY (a) 7,216 units; (b) 3,312 units; (c) 18,672 units were
distributed.
REASON (a&b) Markings on dosage cups not totally compatible with label
dosage instruction.
(c) Labeling provides dosage information not in accordance with
Regulation.21.
PRODUCT Tobramycin Sulfate Injection USP: (a) 10 mg/ml, 2 ml multiple
dose vial shipped as 25-2 ml vial shelf packs.
(b) 40 mg/ml, 2 ml multiple dose vial shipped as 25-2 ml vial
shelf packs.
(c) 40 mg/ml, 30 ml multiple dose vial shipped as individual 30
ml vials.
(d) 40 mg/ml, 2ml syringe shipped as 25-2 ml syringe shelf
packs, injectable prescription sterile solutions for
intramuscular or intravenous use as an antibiotic.
Recall #D-426/427-2.
CODES Lot numbers: (a) 022304 EXP 8/93;
(b) 022302 EXP 8/93; (c) 022162 EXP 8/93; (d) 022024 EXP 8/93.
MANUFACTURER Elkins-Sinn, Inc., subsidiary of A. H. Robins Company, Cherry
Hill, New Jersey.
RECALLED BY Manufacturer, by letter June 16, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 12,550 2-ml vials manufactured and shipped as 502 25-unit
shelf packs, firm estimates 645 2-ml vials remain on the market.
(b) 129,800 2-ml units shipped as 5,192 25-2 ml vials shelf
packs; firm estimates 13,560 2-ml vials remain on the market.
(c) 14,650 2-ml syringe units shipped as 586 25 2-ml syringe
shelf packs; firm estimates 1395 2 ml-syringes remain on the
market.
(d) 8,820 30-ml units packaged individually were distributed;
firm estimates 593 30-ml vials remain on the market.
REASON Products distributed prior to process validation.
PRODUCT Zantac (ranitidine hydrochloride) injection, 50 mg, 25 mg/ml,
in 2 ml single dose, syringe, Recall #D-428-2.
CODE Lot #lGl375, EXP Nov l992.
MANUFACTURER Survival Technology Inc. (Manufacturer), Bethesda, Maryland.
RECALLED BY Glaxo, Inc., Zebulon, North Carolina (own label distributor),
by telephone July 1, 1992, followed by letter July 9, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 8,487 cartons were distributed; firm estimates 7,827 cartons
remain on the market.
REASON Several unit cartons of Zantac contained 2 ml syringes of
Toradol.
-7-
PRODUCT Oral Morphine Solution, 10 mg/5 ml, in 120 ml bottles, a Rx and
DEA Schedule II controlled substance for relief of moderate to
severe pain. Recall #D-430-2.
CODE Lot #WAO.
MANUFACTURER P.F. Laboratories, Totowa, New Jersey.
RECALLED BY The Purdue Frederick Company, Inc., Norwalk, Connecticut, by
telephone June 18-19, 1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 3,600 bottles were distributed.
REASON A bottle of 10 mg/5 ml strength was labeled as 20 mg/5 ml
strength.
UPDATES Various injectable drug products, manufactured by Lyphomed,
Division of Fujisawa USA, Inc., Recall #D-365/371-2, which
originally appeared in the June 10, 1992 Enforcement Report and
as an update in the July 2, 1992 Enforcement Report, has been
extended a second time as follows: Sodium Chloride Injection,
USP, 0.9% has been extended to include lot numbers 320073 EXP
1/94 and 311312 EXP 12/93.
Various injectable drug products, manufactured by Lyphomed,
Division of Fujisawa USA, Inc., Recall #D-401/403-2, which
appeared in the July 2, 1992 Enforcement Report has been
extended as follows: Gentamicin Sulfate Injection, USP
(Pediatric), has been extended to include lot #320049 EXP 1/94.
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
PRODUCT Theo-Organidin Elixir, a Brochodilator Mucolytic-Expectorant
available by prescription, a clear amber liquid, in 1 pint
bottles. Recall #D-429-2.
CODE All codes on product's immediate label or bottle or on 16 ounce
bottles. Lot #2A6003B, LB-051E8-05 (LABEL Code).
MANUFACTURER Denver Chemical Inc., Subsidiary of CW Inc., Humacao, Puerto
Rico
Recalled by Carter Wallace, Cranbury, New Jersey, by telephone May 12 and
14, 1992, followed by letter May 18, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION New Jersey, Illinois, Nevada, Georgia, Puerto Rico.
QUANTITY 3,244 bottles were distributed.
REASON Label error - label declares tablespoon as 5 ml instead of
15 ml.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated AHF;
(d) Fresh Frozen Plasma; (e) Recovered Plasma.
Recall #B-334/338-2.
-8-
CODE Unit numbers: (a) 1811569, 4469193, 4509310, 5185597, 5826321,
5828515, 7107214, 7238501, 7274641, 7395125, 7396738, 7451251,
7488335
(b) 4509310, 5828515, 7238501, 7395125;
(c) 4509310, 5828515, 7274641, 7396738;
(d) 7395125, 7451251, 7488335;
(e) 1811569, 4469193, 4509310, 5185597, 5826321, 5828515,
7107214, 7238501, 7274641, 7396738.
MANUFACTURER J. K. and Susie L. Wadley Research Institute and Blood Bank
Dallas, Texas.
RECALLED BY Manufacturer, by letters dated July 23, 1991, October 25, 1991,
December 12 and 30, 1991, January 29, 1992, February 18, 1992,
March 23, 1992, April 21, 1992, and May 22, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Texas, Florida, California, New Jersey.
QUANTITY (a) 13 units; (b) 4 units; (c) 4 units; (d) 3 units;
(e) 10 units were distributed.
REASON Blood products, which either had the identical unit number as
another product of the same type, or tested negative for all
required viral markers, but were collected from donors who 1)
previously tested repeatedly reactive for the antibody to human
immunodeficiency virus type 1 (anti-HIV-1); 2) participated in
high risk behavior; 3) reported receiving a blood transfusion;
4) reported a history of hepatitis; or 5) received treatment
for rabies, were distributed.
PRODUCT Recovered Plasma. Recall #B-340-2.
CODE Unit #24-08576.
MANUFACTURER Huron Regional Medical Center, Huron, South Dakota.
RECALLED BY Manufacturer, by telephone February 14, 1992, followed by
letter February 25, 1992. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit.
REASON Recovered Plasma, which tested repeatedly reactive for the
antibody to the hepatitis C virus (anti-HCV) and which was
distributed for further manufacture into non-injectable
products, was not labeled as reactive for anti-HCV.
PRODUCT Red Blood Cells. Recall #B-341-2.
CODE Unit #LM37104.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Milwaukee,
Wisconsin.
RECALLED BY Manufacturer, by visit April 16, 1991. Firm-initiated recall
complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit.
REASON Blood product, which tested negative for the antibody to human
immunodeficiency virus type 1 (anti-HIV-1), but was collected
from a donor who previously tested repeatedly reactive for
anti-HIV-1, was distributed.
-9-
PRODUCT Red Blood Cells. Recall #B-342-2.
CODE Unit numbers: 40FE94047, 40FZ02611.
MANUFACTURER American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY Manufacturer, by telephone February 12, 1992, followed by
letter March 6, 1992. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 2 units.
REASON Blood products, improperly tested for the antibody to human
immunodeficiency virus type 1 (anti-HIV-1), were distributed.
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma.
Recall #B-346/348-2.
CODE Unit #56919.
MANUFACTURER Metropolitan Washington Blood Banks, Inc., Sliver Spring,
Maryland.
RECALLED BY Manufacturer, by letter February 26, 1992. Firm-initiated
recall complete.
DISTRIBUTION Washington, D.C.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor who previously tested
repeatedly reactive for the antibody to the human
immunodeficiency virus type 1 (anti-HIV-1), were distributed.
PRODUCT Platelets. Recall #B-353-2.
CODE Unit #MU25703.
MANUFACTURER East Texas Blood Center, Inc., Nacogdoches, Texas.
RECALLED BY Manufacturer, by telephone June 27, 1990. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, which tested positive for rapid plasma reagin
(RPR/syphillis), was distributed.
PRODUCT Platelets. Recall #B-354-2.
CODE Unit #49FF01374.
MANUFACTURER American Red Cross Blood Services, Wichita Falls, Texas.
RECALLED BY American Red Cross Blood Services, Tulsa, Oklahoma, by
returning the unit to ARC, Tulsa on January 10, 1992.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit.
REASON Blood product labeled with the incorrect expiration date was
distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
PRODUCT Platelets. Recall #B-339-2.
CODE Unit #7764646.
-10-
MANUFACTURER J. K. and Susie L. Wadley Research Institute and Blood Bank,
Dallas, Texas.
RECALLED BY Manufacturer, by letters dated July 23, 1991, October 25, 1991,
December 12 and 30, 1991, January 29, 1992, February 18, 1992,
March 23, 1992, April 21, 1992, and May 22, 1992.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON A unit of platelets, labeled with the identical unit number as
another unit of platelets, was distributed.
PRODUCT Platelets. Recall #B-356-2.
CODE Unit #42Y06963.
MANUFACTURER American Red Cross, Cleveland, Ohio.
RECALLED BY Manufacturer, by December 18, 1990. Firm-initiated recall
complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Blood product, not tested for the antibody to human
immunodeficiency virus type 1 (anti-HIV-1), was distributed.
PRODUCT Red Blood Cells. Recall #B-358-2.
CODE Unit #27029-4057.
MANUFACTURER United Blood Services, Hot Springs, Arizona.
RECALLED BY United Blood Services, Texarkana, Texas, by telephone on or
about April 8, 1992. Firm-initiated recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit.
REASON Blood product labeled with an incorrect expiration date was
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
UPDATE Recall #Z-772-2, VIP Bird Infant/Pediatric Ventilator, Part
#15003, which appeared in the July 15, 1992 Enforcement Report,
inadvertently located under the Class III drug category, is a
Class I recall.
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
PRODUCT Soft Thoracic Catheter, size FR 16, used as an accessory to a
Thoracic Drainage System. Recall #Z-857-2.
CODE Catalog #DSTC 16S, lot #02131.
MANUFACTURER Mallinckrodt Anesthesiology, Argyle, New York.
RECALLED BY Deknatel, Inc., Fall River, Massachusetts, by letter May 14,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 897 units were distributed.
REASON The blue tip of the catheter may become dislodged during use.
-11-
PRODUCT Soft Thoracic Catheter, size FR 32, used as an accessory to a
Thoracic Drainage System. Recall #Z-858-2.
CODE Catalog #DSTC 32S, lot numbers: 02478, 02358, 02371A, 02371B.
MANUFACTURER Mallinckrodt Anesthesiology, Argyle, New York.
RECALLED BY Deknatel, Inc., Fall River, Massachusetts, by letter April 22,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Europe.
QUANTITY 7,380 units were distributed; firm estimates very few units
remain on the market.
REASON The blue tip of the catheter may become dislodged during a
routine chest drainage procedure.
PRODUCT Mega Mini Lab Series E-Z Lumbar Puncture Kits:
(a) Sterile Lumbar Puncture Kit, Infant, Catalog #B21001;
(b) Sterile Lumbar Puncture Kit, Infant/Child Catalog #B21002;
(c) Sterile Lumbar Puncture Kit, Child, Catalog #B21003;
(d) Sterile Lumbar Puncture Kit, Adult, Catalog #B21004;
(e) Sterile Lumbar Puncture Kit, Adult, Catalog #B21005;
(f) Sterile Lumbar Puncture Kit, Adult, Catalog #B21006.
Recall #Z-859/864-2.
CODE Lot 911143 EXP 11/93.
MANUFACTURER Mega Medical, Inc., Tampa, Florida.
RECALLED BY Manufacturer, by letter on or about April 9, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Colorado, Florida, Utah, Alabama, Pennsylvania, Georgia,
Wisconsin, Missouri, Virginia, Washington, D.C.
QUANTITY 353 kits were distributed.
REASON The sterility of the device has been compromised by loss of
package integrity or lack of adequate sterilization.
PRODUCT Prosorba Column, used as a plasma filter for the treatment of
Idiopathic Thrombocytopenic Purpura (ITP). Recall #Z-865-2.
CODE l23l9lA, l23l9lB, l23l9lC, l23l9lD, l23l9lE, 0l0292A, 0l0292B,
0l0292C, 0l0292D, 0l0292E, 0l2892A.
MANUFACTURER IMRE Corporation, Seattle, Washington (manufacturer).
Melrath Gasket, Philadelphia, Pennsylvania (component supplier).
RECALLED BY Manufacturer, by telephone May 12, 1992, followed by letter.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 414 units were distributed.
REASON Columns may leak.
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
PRODUCT Schneider Teflon Fixed Core .025 inches, 145 cm, Straight Tip
Guidewires, used to percutaneously deliver a diagnostic
catheter to a specific part of the body. Recall #Z-866-2.
-12-
CODE Lot numbers: 17999, 18342, 18890.
MANUFACTURER Schneider Pittsburgh, Inc., Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by telephone March 5, 1992 followed by letter
March 6 and 12, 1992. Firm-initiated recall complete.
DISTRIBUTION Florida, Texas.
QUANTITY Firm estimates none remains on the market.
REASON One shelf box, labeled as moveable core guidewires, contained
packages labeled as moveable core guidewires but were actually
fixed core guidewires.
MEDICAL DEVICE SAFETY ALERTS
PRODUCT Medtronic SynchroMed Pumps, designed to contain and to
administer parenteral drugs to specific sites:
(a) SynchroMed Model 8615 Implantable Infusion Pump with Filter
and Attached Access Port;
(b) SynchroMed Model 8611H Drug Administration Device with
Model 8500-1 Access Port added as an accessory.
Safety Alert #M-061/062-2.
CODE All serial numbers.
MANUFACTURER Medtronic, Inc., Neurological Division, Minneapolis, MN
ALERTED BY Manufacturer, by letter June 15, 1992.
DISTRIBUTION Nationwide, Argentina, Australia, Canada, Hong Kong, Japan,
Mexico, The Netherlands.
QUANTITY (a) 900 units; (b) 1,533 units were distributed.
REASON Drugs intended for the pump reservoir were inadvertently
injected into the catheter access port during a refill
procedure.
MASS SEIZURES
PRODUCT Oxygen, USP (92-555-816/7).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the products' processing, packing, and
holding do not conform to and are not operated and administered
in conformity with current good manufacturing practice
requirements.
FIRM Sun Medical Equipment Company, Inc., Clawson, Michigan.
FILED May 12, 1992 - U.S. District Court for the Eastern District of
Michigan, Southern Division; Civil #92-CV72620DT, FDC #66423.
SEIZED May 18, 1992 - goods valued at approximately $5,600.
PRODUCT Prescription and over-the-counter drugs (92-506-615).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the products' manufacture, processing,
packing, and holding do not conform to and are not operated and
administered in conformity with current good manufacturing
practice requirements.
FIRM Esquire Pharmaceuticals, Inc., Westmont, Illinois.
FILED June 5, 1992 - U.S. District Court for the Northern District of
Illinois, Eastern Division; Civil #92C3743, FDC #66446.
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SEIZED June 9, 1992 - goods valued at approximately $224,000.
SEIZURES
PRODUCT Attenuating examination gloves (92-607-569).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for the product's manufacture are not in
conformity with current good manufacturing practice
requirements.
Misbranded - The product's premarket notification submitted to
FDA did not provide for resterilization and reuse of the gloves.
FIRM F & L Medical Products Company, Vandergrift, Pennsylvania.
FILED April 9, 1992 - U.S. District Court for the Western District of
Pennsylvania; Civil #92-1052, FDC #66426.
SEIZED April 10, 1992 - goods valued at approximately $42,670.
PRODUCT Oxygen, USP and Nitrogen NF (92-674-648/9).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the products' processing, packing, and
holding do not conform to and are not operated and administered
in conformity with current good manufacturing practice
requirements.
FIRM Thornton Enterprises, also known as South Jersey Welding Supply
Company, Vineland, New Jersey.
FILED June 26, 1992 - U.S. District Court for the District of New
Jersey; Civil #92 CIV 2340(JFG), FDC #66438.
SEIZED July 8, 1992 - goods valued at approximately $52,000.
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END OF ENFORCEMENT REPORT FOR JULY 22, 1992. BLANK PAGES MAY FOLLOW.
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