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.

March 4, 1998 98-09

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I =============
_______________
PRODUCT Ice cream, various flavors labeled for Food Lion,
packaged in ´ gallon cartons and 5 quart plastic
pails:
a) Food Lion Vanilla Flavored Ice Cream, ´ gallon
and 5 quart sizes coded 7-13-98
b) Food Lion Neapolitan Flavored Ice Cream, 5 quart size coded 7-13-98
c) Food Lion Fudge Royale Ice Cream, 5 quart size
coded 7-14-98
d) Food Lion Chocolate Ice Cream, 5 quart size.
Recall #F-273/276-8.
CODE a) 7-13-98; b) 7-13-98; c) 7-14-98; d) 7-14-98.
MANUFACTURER Dairy Fresh, Inc., Winston-Salem, North Carolina.
RECALLED BY Manufacturer, by press release followed by
telephone on October 27, 1997. Completed recall
resulted from sample analysis and follow-up by the
North Carolina Department of Agriculture, Food and
Drug Division.
DISTRIBUTION Delaware, Florida, Georgia, Kentucky, Maryland,
North Carolina, Pennsylvania, South Carolina,
Tennessee, Virginia, West Virginia.
QUANTITY 131,000 containers were distributed; firm
estimates none remains on the market.
REASON Products may have been contaminated with Listeria
monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ===========
_______________
PRODUCT Mayonnaise and salad dressing packaged in 48 fluid
ounce plastic jars:
a) Kraft Mayo Real Mayonnaise, UPC #21000-64014
b) Kraft Miracle Whip Salad Dressing, UPC
#21000-64514
c) Kraft Miracle Whip Light Dressing, UPC
#21000-64595. Recall #F-270/272-8.
CODE a) JUL 13 98 D, JUL 14 98 D, AUG 13 98 D, AUG 14 98 D
b) JUL 15 98 D, JUL 16 98 D, JUL 17 98 D, AUG 10
98 D, AUG 11 98 D, AUG 12 98 D, JUN 23 98 D and
JUN 24 98 D
c) JUL 14 98 D, JUL 15 98 D, AUG 13 98 D, AUG 25
98 D.
MANUFACTURER Kraft Foods, Inc., Garland, Texas.
RECALLED BY Kraft Foods, Inc., Northfield, Illinois, by
memorandum dated February 9, 1998 and by fax or
visit on or about February 16, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 42,339 cases (6 jars per case) were distributed.
REASON Products are in containers which are short weight by 2 fluid ounces,

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
============
_______________
PRODUCT Slow Fe Tablets, (160 mg dried ferrous sulfate,
USP, equiv. to 50 mg elemental iron), OTC, blister
packaged units of 90 units, indicated for the
treatment of anemia.
Recall #D-079-8.
CODE Lot numbers: U09868K EXP 7/99, U10076K EXP 8/99, U10077K EXP 8/99.
MANUFACTURER Novartis Pharmaceutical, West Sussex, England.
RECALLED BY Novartis Consumer Health, Inc., Summit, New
Jersey, by telephone on September 4, 1997, and
November 24, 1997, and by letters mailed on
September 5, 1997, and December 12, 1997. Firm-initiated recall ongoing.
DISTRIBUTION California, Georgia, Pennsylvania, Nebraska.
QUANTITY 39,324 cartons were distributed.
REASON Labeling lacks tetracycline, nursing, and
pregnancy warnings.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Upjohn brand Cortef Oral Suspension
(Hydrocortisone Cypionate oral suspension, USP),
10 mg per 5 mL, in 4 fluid ounce bottles, Rx oral anti-inflammatory.
NDC #0009-0142-01. Recall #D-080-8.
CODE Lot #86BTF EXP 10/31/02.
MANUFACTURER Pharmacia & Upjohn, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by telephone on January 27, 1998.
Firm-initiated recall complete.
DISTRIBUTION Connecticut, Georgia, Indiana, Massachusetts, New
Jersey, New York, North Carolina, Ohio, Virginia,
The United Kingdom.
QUANTITY 108 bottles were distributed.
REASON Subpotent.

_______________
PRODUCT Glyburide Tablets, 2.5 mg, in 90 tablet bottles,
Rx oral blood-glucose-lowering drug of the
sulfonylurea class. NDC #59762-3726-6. Recall
#D-081-8.
CODE Lot #135JU EXP 7/98.
MANUFACTURER Pharmacia & Upjohn, Puerto Rico.
RECALLED BY Greenstone Limited (a subsidiary of Pharmacia &
Upjohn Co.) Portage, Michigan, by letter on
January 5, 1998. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 10,426 bottles were distributed.
REASON Mislabeling - Product bears the incorrect
expiration date.

_______________
PRODUCT Prozac Pulvules (Fluoxetine Hydrochloride capsules), 10 mg, in units of 100 and 2000 count bottles, Rx indicated for the treatment of
depression, obsessive-compulsive disorder and
bulimia nervosa, under the Dista label.
NDC #0777-3104-02 BOTTLES OF 100
NDC 0777-3104-07 BOTTLES OF 2000.
Recall #D-082-8.
CODE LOT NUMBER EXP. DATE PACKAGE
1AH81B JULY 1, 1999 100 CAPSULES
1AH82B JULY 1, 1999 100 "
1AH83M JULY 1, 1999 2000 "
1AG33M JULY 1, 1999 2000 "
1AG34M JULY 1, 1999 2000 "
1AG35M JULY 1, 1999 2000 ".
MANUFACTURER Lilly Del Caribe, Inc., Carolina, Puerto Rico.
Shionogi Qualicaps, Whitsett, North Carolina
(capsule supplier).
RECALLED BY Eli Lilly Company, Indianapolis, Indiana, by
letter and by fax on January 22, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 106,190 bottles were distributed.
REASON Misbranded - Some capsules are incorrectly
imprinted as "20 mg units" and incorrectly item
coded for 20 mg capsules as "3105".

_______________
PRODUCT Prempro Tablets (Conjugated Estrogens
0.625mg/Medroxyprogesterone Acetate 2.5mg ), in
unit dose cartons of 28 tablets (14 tablets per
card) sold in cartons of 3, prescription hormone
replacement therapy.
NDC #0046-0875-01/02. Recall #D-083-8.
CODE Lot #9970927 EXP 7/99.
MANUFACTURER Wyeth-Ayerst Laboratories, Rouses Point, New York.
RECALLED BY Wyeth Ayerst Laboratories/Whitehall Robbins,
Richmond, Virginia, by letter dated January 29,
1998. Firm-initiated recall ongoing.
DISTRIBUTION Mid-Western United States.
QUANTITY 24,931 cartons were distributed.
REASON Content uniformity failure (medroxyprogesterone
acetate superpotent).

_______________
PRODUCT Xtra-Lax Laxative Tablets (Phenolphthalein), in
boxes of 30, 60, and 75 tablets, OTC product for
the relief of irregularity, under the following
brand names: Guardian Drug Co. (GDC), Kenney,
Mason Remedies, Drug Imporium, Q-Lax
(NDC 0603-0260-16), Relief Plus.
Recall #D-084-8.
CODE LOT # EXP. DATE
142-3071 01/98
142-3111 04/98
142-3237 05/98
142-3469 10/98
142-3565 11/98
142-3756 04/99
142-3828 05/99.
MANUFACTURER Guardian Drug Company, Trenton, New Jersey.
RECALLED BY Manufacturer, by letter on October 24, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 2,538 cases were distributed.
REASON Product failed disintegration testing.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-542/544-8.
CODE Unit #53H09225.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated November 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION Maryland and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products, which tested negative for the
antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor
who previously tested repeatedly reactive for
anti-HIV-1, Western blot negative.

_______________
PRODUCT Albumin (Human) 25% in 100ml Vials.
Recall #B-568-8.
CODE Lot Numbers: 684R004, 6C4R016A, 684R095.
MANUFACTURER Bayer Corporation, Clayton, North Carolina.
RECALLED BY Bayer Corporation, Elkhart, Indiana, by letter
dated January 9, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION Arizona, California, Florida, Indiana, New York,
Pennsylvania, Tennessee, Indonesia, Bulgaria,
Canada.
QUANTITY 15,777 vials were distributed; firm estimated that
very little product remained on market at time of recall initiation.
REASON Albumin, for which sterility assurance was not
sufficiently documented.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-582/583-8.
CODE Unit #53KN35680.
MANUFACTURER American Red Cross, Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated October 27, 1997,
and by fax on October 24, 1997.
Firm-initiated recall complete.
DISTRIBUTION District of Columbia and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for antibody to the
human immunodeficiency virus type 1 (anti-HIV-1), but collected from a donor who previously tested
repeat reactive for anti-HIV-1, Western Blot
negative and was incorrectly reentered.

_______________
PRODUCT Red Blood Cells. Recall #B-584-8.
CODE Unit #V39366.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY Manufacturer, by letter dated December 10, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for antibody to the human immunodeficiency virus type 1 (anti-HIV-1),
but was collected from a donor who previously
tested repeat reactive for anti-HIV-1, Western
Blot negative and was incorrectly reentered.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-593/594-8.
CODE Unit #49L83598.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by letter dated November 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
reported travel to an area designated as endemic
for malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-595-8.
CODE Unit #4918320.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, by letter dated September 29, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood products were tested negative for the
antibody to Hepatitis B core antigen (anti-HBc),
but was collected from a donor who previously
tested repeat reactive on two previous occasions
for anti-HBc.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-597/598-8.
CODE Unit #0819167.
MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo,
Texas.
RECALLED BY Manufacturer, by telephone on October 14, 1997,
and by letter dated January 16, 1998. Firm-initiated recall complete.
DISTRIBUTION Tennessee and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for Cytomegalovirus
(CMV) by EIA, but collected from a donor who
previously tested repeat reactive for CMV.

_______________
PRODUCT Platelets. Recall #B-605-8.
CODE Unit #03G00006.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by letter dated February 9, 1996.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to an area considered endemic for
malaria.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-606/607-8.
CODE Unit #03GF25194.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by letter dated August 17, 1995.
Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who
traveled to an area considered endemic for
malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-609-8.
CODE Unit #21GG85881.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letter dated January 7, 1998.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who was
exposed to hepatitis C.

_______________
PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF.
Recall #B-610/611-8.
CODE Unit #21GM76062.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by telephone on December 3, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of cancer.

_______________
PRODUCT Platelets. Recall #B-622-8.
CODE Unit #4540677.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter on December 1, 1997.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of clotted
Red Blood cells.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma; d) Buffy Coat. Recall #B-625/628-8.
CODE Unit #18S63459.
MANUFACTURER American Red Cross, Lansing, Michigan.
RECALLED BY Manufacturer, by telephone on May 28, 1997 and by
letters dated May 29, 1997 and April 16, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan, California, New Jersey.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from two donors with
the same whole blood number and one donor deferred
for body piercing within twelve months of
donation.

_______________
PRODUCT a) Platelets; b) Fresh Frozen Plasma.
Recall #B-631/632-8.
CODE Unit #18FS12068.
MANUFACTURER American Red Cross, Lansing, Michigan.
RECALLED BY Manufacturer, by letter on October 23, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component was distributed.
REASON Blood products corresponded to a unit of clotted
Red Blood Cells.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Platelets, Pheresis. Recall #B-317-8.
CODE Unit numbers: 17FX05851-12050, 17FX05851-12051.
MANUFACTURER American Red Cross, North Central Blood Services,
St. Paul, Minnesota.
RECALLED BY Manufacturer, by telephone on October 1, 1996, and
by letter dated October 11, 1996. Firm-initiated
recall complete.
DISTRIBUTION Minnesota.
QUANTITY 2 units were distributed.
REASON The product exceeded the acceptable standard for a
leukoreduced blood component.

RECALLS AND FIELD CORRECTIONS: DEVICES --
==================
_______________
PRODUCT Coulter Maxm Series Analyzers, an automated
differential cell counter:
a) Model No. 0041, COULTER MAXM System;
b) Model No. 0056, COULTER MAXM with AUTOLOADER;
c) Model No. 0141, COULTER MAXM with Reticulocyte
Analysis;
d) Model No. 0156, COULTER MAXM with AUTOLOADER
and Reticulocyte Analysis;
e) Model No. 0940, COULTER MAXM with Japanese DMS;
f) Model No. 0941, COULTER MAXM with AUTOLOADER
and Japanese DMS.
Recall #Z-335/340-8.
CODE All serial numbers.
MANUFACTURER Coulter Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter on August 8, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 2,075 units were distributed.
REASON Components in the reagent level sensor area of the
instrument can ignite.

_______________
PRODUCT Sterile Cotton Tipped Applicators (6" wood Stick) used in various custom procedure trays:
a) Heart Pack, Product No. CV4482F
b) Laparoscopy Pack, Product No. OBC595B
c) Laser Laparoscopy Tray, Product No. OB4283D
d) Basic Ophthalmology Pack, Product No. EYC024
e) Prep Set, Product No. PRC022A
f) Bone Tray w/ aux., Product Nos. GS6226F & G
g) C-Section Pack, Product No. OB5170F
h) Tubal Pack, Product No. OB5325E
I) Open Heart Pack, Product No. CVC378B
j) Eye Pack, Product Nos. EYL351 & A
k) Total Joint Tray, Product No. OP6116F
l) Pelvic Exam Tray, Product No. OB8788A
m) Lap Chole Tray, Product Nos. LZ6324F & G,
Product No. LZB773A, Product No. LZC594A,
n) Nasal Pack, Product No. NA4911E
0) Pediatric CVP/TPN Tray, Product No. DR5088
p) Bone Marrow Tray, Product No. GSD492B.
Recall #Z-341/356-8.
CODE Lot numbers: a) Nos. 46081720, 46082617,
46102297; b) 46122312, 47012250;
c) 47022362; d) 46082040; e) 46111764;
f) 46081988, 46102375, 46112056, 45112505,
46120319, 46122560, 47010303, 47011275,
47030845, 47031772;
g) 46091390, 46111016, 46121656, 47010809,
97010028RS, 47032329;
h) 46101185, 46101340, 46120067, 47013059,
47021050, 47051560; I) 46090748;
j) 46081056, 46111888, 47021884;
k) 47012922, 47022141, 47022339; l) 46082746;
m)Product Nos. LZ6324F & G, Lot Nos.46090754,
46100805, 46101898, Product No. LZB773A, Lot No.
46080940, Product No. LZC594A, Lot Nos. 46082136,
46112368, 47021591; n) Lot No. 46091335;
o) 46082038, 46082610, 46110300, 46122626,
47021475; p) 46082667 46090026, 46120655,
47011568.
MANUFACTURER Maxxim Medical, Richmond, Virginia (custom tray);
Banta Healthcare Products, Inc. (Formerly Ling
Products, Inc.), Neenah, Wisconsin (cotton tip
applicator).
RECALLED BY Maxxim Medical, Richmond, Virginia, by letter
dated June 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,706 trays were distributed.
REASON The cotton tip of the applicator may detach during
use.

_______________
PRODUCT EIE/Analytic Power Cart, Part #971-0100, used in
dental offices to supply power to and serve as a
base for other dental devices and accessories.
Recall #Z-360-8.
CODE Serial numbers: 05998&9, and 060000 through
060021. Additionally, 6 units had no serial
numbers assigned by ASI Medical, Inc.
MANUFACTURER ASI, Medical, Inc., Englewood, Colorado (contract
manufacturer).
RECALLED BY EIE/Analytic, Division of Ormco Corporation,
Glendora, California, by letter dated December 5,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, Arizona, California, Colorado, Florida,
Illinois, Massachusetts, Maine, Maryland, North
Carolina, New Jersey, New Mexico, Oklahoma, Utah,
Korea.
QUANTITY 28 units were distributed.
REASON The installation and design of the Power Carts
electrical system may have been a factor in the
malfunction of the unit.

_______________
UPDATE Recall #Z-326-8, Exactech, Inc., recall of Opteon
brand Femoral Stems, which appeared in the
February 18, 1998 Enforcement Report is being
updated as follows:
PRODUCT Opteon brand Femoral Stems, with laser cut
alignment marks, indicated for use in skeletally
mature individuals undergoing primary or secondary
surgery for proximal femoral fracture where
prosthetic replacement is determined by the
surgeon to be the preferred treatment. Recall
#Z-326-8.
CODES Part # Serial Number Range
102-01-01 any serial number before UHKG
102-01-02 any serial number before UGUH
102-01-03 any serial number before UGQM
and including UGNT-UGPB
102-01-04 any serial number before UGTA
102-01-05 any serial number before UGJN.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III =========
_______________
PRODUCT NeuroCare Group Camino Heyer-Schulte Hermetic II
External CSF Drainage Management System, Sterile for Single Use Only, used to provide a sterile fluid path for draining cerebrospinal fluid from the ventricles of the brain or the lumbar subarachnoid space to a collection bag. The primary indication for the product is external drainage in the management of hydrocephalic shunt
infections.
Recall #Z-334-8.
CODE Lots 1961716, 1970452, 1970745, and 1970746.
MANUFACTURER Heyer-Schulte NeuroCare, L.P., Anasco, Puerto
Rico.
RECALLED BY Heyer Schulte NeuroCare, L.P., Pleasant Prairie,
Wisconsin, by telephone on February 5, 1998,
followed by letter dated February 2, 1998. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 677 units were distributed.
REASON Part of the device, a burette chamber, may break off at the junction with the tubing and stopcock.

______________
PRODUCT Recall #Z-329/330-8, Maxima Forte Oxygenator (Medtronic, Inc., Anaheim, California), which appeared in the February 25, 1998 Enforcement Report is a Class III Recall.

END OF ENFORCEMENT REPORT FOR MARCH 4, 1998. BLANK PAGES MAY FOLLOW.

####

End of Enforcement Report for