ENFORCED>FDA Enforcement Report
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Enforcement Report
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ENFORCE
08/21/1996
ENFORCEMENT REPORT FOR 08/21/96
August 21, 1996 96-34
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Betty Crocker, SuperMoist Lemon, Pudding in
the Mix, cake mix, net weight 1 pound 2.25
ounces (18.25 ounces). Recall #F-656-6.
CODE First five digits of production code: A607Z,
A608Z, A610Z, A611Z, A611T, A612T, A613T,
A620M, A621M, B609Z, B610Z, L625Z, M601T,
M602T, M610Z, M611Z.
MANUFACTURER General Mills, Inc., Cedar Rapids, Iowa;
General Mills, Inc., Toledo, Ohio;
General Mills, Inc., Lodi, California.
RECALLED BY General Mills, Inc., Minneapolis, Minnesota,
by letters on July 18 and 24, 1996. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 91,284 cases (12 boxes per case) were
distributed.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Super G brand Vitamin E 200 IU ** 100
Capsules. Recall #F-655-6.
CODE Lot #4994 EXP 8/99.
MANUFACTURER International Labs, Inc., St. Petersburg,
Florida.
RECALLED BY Manufacturer, by telephone on July 12, 1996
and by press release issued by Giant Foods on
July 12, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Maryland, District of Columbia, Delaware, New
Jersey, Virginia.
QUANTITY 5,360 bottles were distributed.
REASON Some bottles contained a chloral hydrate
capsule which is a sedative that induces
sleep.
_______________
PRODUCT Various flavored Veryfine Apple Quenchers, in
46 fluid ounce bottles:
(a) Apple Raspberry Cherry
(b) Apple Strawberry Banana
(c) Apple Peach Plum
(d) Apple Pear Passion Fruit.
Recall #F-657/660-6.
CODE (a) V960222A; (b) V960232A; (c) V960242A;
(d) V960242B.
MANUFACTURER Veryfine Products, Inc., Westford,
Massachusetts.
RECALLED BY Manufacturer, by letter and press release
dated March 15, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Massachusetts, Rhode Island, Connecticut, New
Hampshire, Maine, Vermont, New York, New
Jersey, Pennsylvania, Maryland, Virginia,
Illinois, Wisconsin, Florida.
QUANTITY 11,145 cases (6 bottles per case) were
distributed.
REASON Product is adulterated due to the presence of
mold and yeast.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Norpace CR Disopyramide Phosphate Extended-
Release Capsules, 150 mg, Rx antiarrhythmic.
Recall #D-226-6.
CODE Lot #6A482 EXP 1/98.
MANUFACTURER G.D. Searle & Company, Caguas, Puerto Rico.
RECALLED BY G.D. Searle & Company, Skokie, Illinois, by
letter dated August 2, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,791 bottles were distributed; firm estimated
that 50% of product remained on market at time
of recall initiation.
-2- REASON Some units may contain Maxaquin
(antimicrobial) tablets due to packaging
error.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Suprax (Cefixime) Film Coated Tablets, 200 mg
and 400 mg, in bottles of 50 and 100, and in
10 tablet physician sample packages, a
cephalosporin antibiotic.
Recall #D-220/222-6.
CODE 50 Tablet - 200 mg. - Codes: 362-814 (EXP
10/96); 362-815 (EXP 10/96); 368-824
(EXP 10/96)
100 Tablet - 200 mg. - Code: 368-826
(EXP 10/96)
50 Tablet - 400 mg. - Codes: 360-812 (EXP
6/96); 376-834 (EXP 6/96); 362-802 (EXP
12/96); 368-809 (EXP 12/96); 372-823 (EXP
1/97); 368-830 (EXP 1/97); 372-829 (EXP 1/97)
100 Tablet - 400 mg. - Code: 358-801
(EXP 6/96)
10 Tablet Physician Samples - 400 mg. - Code:
368-804 (EXP 12/96); 376-817 (EXP 11/96);
382-800 (EXP 11/96).
MANUFACTURER Lederle Laboratories, Sanford, North Carolina.
RECALLED BY Whitehall-Robins Wyeth-Ayerst, Richmond,
Virginia, by letter dated March 29, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, United Kingdom, Puerto
Rico, Virgin Islands.
QUANTITY Firm estimates none remains on the market.
REASON Product subpotent near end of expiry due to
change in storage temperatures at the
manufacturer.
_______________
PRODUCT Qualitest Products brand Prednisone Tablets,
USP, 5 mg, in blister-packs of 21 tablets.
Recall #D-223-6.
CODE Lot #041056A EXP 2/98.
MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte,
North Carolina (packager/responsible firm)
RECALLED BY Qualitest Products, Inc., Huntsville, Alabama,
by letter on July 25, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Florida, Georgia, Indiana, Iowa, Kentucky,
Missouri, North Carolina, Ohio, South
Carolina, Tennessee, Virginia.
QUANTITY 1,195 packs were distributed.
-3- REASON Dosing instructions are defaced as the blister
pack is used due to inversion of the label on
the pack.
_______________
PRODUCT Glucotrol (Glipizide) Tablets, 10 mg, in
bottles of 100, prescribed for the control of
hyperglycemia. Recall #D-224-6.
CODE Lot #58P021A EXP 5/98.
MANUFACTURER Pfizer - Roerig, Inc., New York, New York.
RECALLED BY AmeriSource Health Services, doing business as
American Health Packaging (AHP), Columbus,
Ohio (repacker), by electronic mail message on
July 24, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,352 bottles were distributed.
REASON Side panel incorrectly identifies strength as
5 mg; actual strength is 10 mg.
_______________
PRODUCT Tornalate (Bitolterol Mesylate) in 15 ml
metered dose inhaler canisters, indicated for
prophylactic and therapeutic use as a
bronchodilator. Recall #D-225-6.
CODE Lot #B420NC EXP 3/98.
MANUFACTURER Sterling Pharmaceuticals, Inc., (now NYCOMED,
Inc.), Barceloneta, Puerto Rico.
RECALLED BY Dura Pharmaceuticals, Inc., San Diego,
California (distributor), by telephone on
January 15, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION New Jersey, New York, Texas, Pennsylvania,
Florida, Nebraska, South Carolina, Virginia.
QUANTITY 516 units were distributed.
REASON Incorrect expiration date; 9/96 assigned
instead of 9/98.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-569-6.
CODE Unit numbers: 6007971, 6007972, 6007981,
6026830, 6026839, 6026862.
MANUFACTURER Community Blood Center of the Ozarks,
Springfield, Missouri.
RECALLED BY Manufacturer, by telephone on February 20,
1996. Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 6 units.
REASON Blood products corresponding to a unit of
pooled Platelets were contaminated with
Staphylococcus epidermidis.
-4- _______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma. Recall #B-571/573-6.
CODE Unit numbers: (a) 0123671, 5615211; (b)
0123671, 5615211; (c) 0123671, 5615211.
MANUFACTURER North Jersey Blood Center, East Orange, New
Jersey.
RECALLED BY Manufacturer, by telephone on November 8,
1994. Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY (a) 2 units; (b) 2 units; (c) 2 units.
REASON Blood products tested negative for 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.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Recovered Plasma.
Recall #B-574/577-6.
CODE (a) S18957, S27934, S29497, S30692, S30977,
S34061, S38053, S38525, S40428, S65634,
S40925, S43624, S42582, S14060, S18426,
S18352, S19477, S09773, S26368, S26289,
S28672, S28660, S30489, S26586, S26874,
S35162, S35196, S30350, S38725, S38732, S43035
(b) S18957, S27934, S29497, S30692, S34061,
S38525, S65634, S42582, S18426, S18352,
S19477, S26368, S26289, S28672, S26586,
S26874, S35162, S35196, S38732
(c) S18957, S38525, S40428, S65634, S14060,
S30350
(d) S27934, S29497, S30692, S30977, S34061,
S38053, S40925, S42582, S18426, S18352,
S19477, S22405, S26368, S26289, S28672,
S28660, S30489, S26586, S26874, S35162,
S35196, S38725, S38732, S43035.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY Manufacturer, by letter dated May 3 or June
24, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Illinois, Indiana, Virginia, New York.
QUANTITY (a) 31 units; (b) 19 units; (c) 6 units; (d)
24 units.
REASON Blood products were tested for antibody to the
human immunodeficiency virus type 1 (anti-HIV-
1) and hepatitis B surface antigen (HBsAg)
using instrumentation that did not meet
manufacturer specifications.
-5-
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Red Blood Cells. Recall #B-570-6.
CODE Unit #29133 6839.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on March 5, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product remained at room temperature for
an unacceptable length of time.
_______________
PRODUCT Platelets, Pheresis. Recall #B-590-6.
CODE Unit #40P44941.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on March 4, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON A unit of Platelets, Pheresis was not stored
under continuous agitation.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Sceptor System Anaerobe MIC/ID Panels, a
microorganism identification and
susceptibility test panel which are intended
for use with Sceptor Anaerobe Broths for
identification and susceptibility testing of
anaerobic bacteria from clinical specimens.
Recall #Z-980-6.
CODE Catalog #80305, lot numbers: 501306 EXP
2/1/95 and 408317 EXP 9/1/95.
MANUFACTURER Becton Dickinson Microbiology Systems (BDMS),
Cockeysville, Maryland.
RECALLED BY Manufacturer, by letter on May 31, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nationwide, Singapore, Taiwan, Mexico,
Belgium, Canada.
QUANTITY 108 cartons of lot 501306 and 102 cartons of
lot 408316 were distributed; Firm estimates
none remains on the market.
REASON The antimicrobial agent Metronidazole in these
panel lots have been found to be incorrect,
with the actual panel well concentrations
being twice the amount indicated in the
labeling.
-6- _______________
PRODUCT Various Gauze Bandage Compresses and Roller
Bandages individually packaged in heat sealed
clear plastic poly bags:
(a) Product #10-40-13 - Triangular Bandage 40"
x 40" x 56"
(b) Product #10-50-05 - Bandage Compress 2"
(c) Product #10-50-07 - Bandage Compress 2"
Off-Center
(d) Product #10-60-05 - Bandage Compress 3"
(e) Product #10-60-07 - Bandage Compress 3"
Off-Center
(f) Product #10-70-05 - Bandage Compress 4"
(g) Product #10-70-07 - Bandage Compress 4"
Off-Center
(h) Product #10-80-02 - 18" x 36" Gauze
Compress
(i) Product #10-80-04 - 36" x 36" Gauze
Compress
(j) Product #10-80-06 - 24" x 72" Gauze
Compress
(k) Product #10-90-01 - Gauze Roller Bandage
1" x 6 yards
(l) Product #10-90-02 - Gauze Roller Bandage
2" x 6 yards
(m) Product #10-90-03 - Gauze Roller Bandage
4" x 6 yards. Recall #Z-1022/1034-6.
CODE None. All product labeled as sterile
distributed since January 1995.
MANUFACTURER Textus Ningbo Manufacturing Company, Ltd. Bai
Dy, Fenghua Peoples Republic of China.
RECALLED BY Textus USA, Inc., Peoria, Illinois, by letter
dated July 22, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Ohio, Kansas, California, New Jersey.
QUANTITY 71,110 pieces were distributed; firm estimated
that 10-15% of product remained on market at
time of recall initiation.
REASON There is a lack of assurance of sterility of
the bandages and compresses.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS I
=============
_______________
PRODUCT Bulk Supersweet Feeds Commercial 25/50
Medicated, starter ration for young pigs.
Recall #V-022-6.
CODE Batches 24-30.
MANUFACTURER Supersweet West, L.P., Garden City, Kansas.
RECALLED BY Consolidated Nutrition, L.C., Fort Wayne,
Indiana, on June 7, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Colorado.
-7- QUANTITY 26,013 pounds were distributed.
REASON Rumensin (monensin) was inadvertently added to
the feed instead of the approved combination
of chlortetracycline/sulfathiazole/penicillin.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
============
_______________
PRODUCT Medisca brand Clenbuterol Hydrochloride, bulk
powder, in 1, 5 and 10 gram bottles, used to
treat respiratory problems in horses.
Recall #V-023-6.
CODE Catalog #10255, Lot numbers: CBH0895 EXP 9/00
and 100/M10 EXP 10/95.
MANUFACTURER Medisca, Inc., St. Laurent, Quebec, Canada
(supplier).
RECALLED BY Medicsca, Inc., Plattsburgh, New York
(distributor), by telephone followed by letter
on June 17, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Oklahoma, Minnesota, Wisconsin, Arizona,
Maryland, Virginia, Alabama, Arkansas,
Colorado.
QUANTITY 20 grams were distributed.
REASON Product is an unapproved new animal Drug -
Import Alert (#68-03) exists for automatic
detention of clenbuterol in any form from
Canada or other countries unless an approved
INAD exists.
_______________
PRODUCT (a) Thyroid Powder packaged in 2 pound 5
ounce, 1 pound, and 10 pound containers, Rx,
for use in equine as a supplemental source of
thyroid, under the Eudaemonic Corporation
label;
(b) Equisyn-T4 Levothyroxine Sodium Powder,
Rx, for use in equine as a supplemental source
of the thyroid hormone T4, under the
Eudaemonic Corporation label and one private
name, Levothyroxine Sodium Powder, under the
Burns Veterinary Supply, Inc. label.
Recall #V-024/025-6.
CODE: (a) Lot numbers - Eudaemonic Corporation -
1014-1 April '97
1014-2 April '97
2064-2 July '97
2064-3 July '97
2064-4 July '97
3114-1 Nov '97
3114-2 Nov '97
3114-3 Nov '97
3414-1 Dec '97
-8- 3414-2 Dec '97
3414-3 Dec '97
2505-4 Sept '98
3635-1 Dec '98
0866-1 Mar '99
(b) Lot # Expiration Date
2904-1 Sept '96
3344-3 Nov '96
2994-3 Oct '96
1325-1 May '97 (Burns)
1505-3 June '97 (Burns).
MANUFACTURER Eudaemonic Corporation, Omaha, Nebraska.
RECALLED BY Manufacturer, by issuing an undated
"Withdrawal Notice to Distributor Level" on or
about June 11, 1996, and by letter July 18,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 15,808 l-pound containers; 278 10-pound
containers; 2,227 2-pound 5 ounce containers
(b) 2,910 l-pound containers; 329 10-pound
containers; 200 2-pound 5 ounce containers
were distributed.
REASON Stability data for Levothyroxin Sodium and
Equisyn T-4 does not support labeled
expiration date.
_______________
PRODUCT (a) Chlorhexi Derm Scrub, antimicrobial scrub
for the preparation of a surgically aseptic
site, one gallon size, Product Number 17-680
(b) Chlorhexi Derm Shampoo with Chlorhexidine,
Antiseptic, Antifungal, Cleanser, one gallon
size, Product Number 15-640
(c) Clear X Ear Cleansing Solution, 4 ounce
bottle, Product #10-005
(d) CortiCalm Lotion, anti-inflammatory,
antipruritic, 1% Hydrocortisone, 6 ounce
bottle, Product No. 19-820
(e) Equitar Shampoo, used to treat Equine
Seborrhea and other equine Dermatoses, in 32
ounce size Product No.9-398, and in one gallon
size Product No. 9-399
(f) LyTar SHAMPOO, For Dogs Only,
Antiseborrheic, Antiseptic, Antipruritic, in
one gallon size, Product No. 1-310, 12 ounce
size, Product No. 9-302, 6 ounce size, Product
No. 1-300
(g) OxyDex SHAMPOO, Topical Antibacterial
Therapy, in 6 ounce size, Product No. 1-200,
lot numbers 21515 and 29225 and in 12 ounce
size, Product No. 6-230
(h) Relief CREME RINSE, Antipruritic, in one
gallon size, Product number 19-675, 12 ounce
-9- size, Product number 18-960, and in a 8 ounce
size, Product number 18-940
(i) Relief Antipruritic SHAMPOO, 8 ounce size,
Product number 18-900
(j) SebaLyt SHAMPOO All-Purpose Antiseborrheic
Formulation, one gallon size, Product number
5-360, in 12 ounce size, Product number 9-355,
in 6 ounce size, Product number 5-350
(k) SeboRX SHAMPOO For Dogs and Cats, to
reduce scaling and seborrheic activity,
antiseptic and keratolytic, in one gallon size
Product number 19-375, and in 8 ounce size,
Product number 19-375
(l) Sulf OxyDex SHAMPOO, Topical Antibacterial
Therapy, in one gallon size, Product number
10-207 and in 12 ounce size, Product number
10-206, and in 6 ounce size, Product number
10-205
(m) Skin Formula 3V Caps Dietary Supplements,
containing Omega 3 fatty acids plus Vitamins A
D and E, which are beneficial for the
maintenance of healthy skin and coats in dogs
and cats, in 60 capsule size bottles, for
"Small and Medium Breeds", Product number
20-140, and for "Medium and Large Breeds"
product number 20-141, for "Large and Giant
Breeds" Product number 20-142.
Recall #V-026/038-6.
CODE Lot numbers: (a) 159170; (b) 558280;
(c) 18535, 24915; (d) 06855;
(e) 155021, 157211; (f) 156201, 3350301,
155280, 151290, 257101, 3552101, 150101,
150211, 258011, 353111; (g) 21515, 29225,
28215, 33125, 33235; (h) 5304, 5291;
(i) 5390, 5471, 259080, 157021, 251121;
(j) 154280, 153280, 151190, 351090, 153070,
2991, 153070, 25815; (k) 4499, 4530;
(l) 28335, 19515, 34615, 27645;
(m) 50263, C328C5, C349C5, 0524F51, 0525F51,
50264, C329C5, C350C5, 0531F51, 50286, C330C5,
C351C5, 0504F51.
MANUFACTURER DVM Pharmaceuticals, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter dated June 11, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 313,841 product units were distributed.
REASON Products assayed either above or below the
specified potency ranges. Products are super
and subpotent.
-10-
END OF ENFORCEMENT REPORT FOR AUGUST 21, 1996. BLANK PAGES MAY FOLLOW.
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