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
11/13/1991
Recalls and Field Corrections: November 13, 1991
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
Product: Orzo Pasta, 2 pounds. Recall #F-043-2.
Code: None.
Manufacturer: Ital Pasta Limited, Brampton, Ontario, Canada.
Recalled by: Ferro Foods Corporation, Brooklyn, New York, by
letter July 17, 1991. Firm-initiated recall ongoing.
-1-
Distribution: New York.
Quantity: 252 cartons were distributed.
Reason: Product is contaminated with Candida Glabrata and S. Aureus.
----
Product: Queso Fresco Margarita Mexican Style Fresh White Cheese,
in 5 ounce plastic packages. Recall #F-038-2.
Code: AUG 16 1991.
Manufacturer: The Quay Corporation, Skokie, Illinois.
Recalled by: Manufacturer, by visit July 29, 1991. Firm-initiated
recall complete.
Distribution: Chicago, Indiana, Wisconsin.
Quantity: 30 - 40 cartons (70 packages per carton) were
distributed.
Reason: Product is contaminated with Enterotoxigenic E. coli.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Isosweet 100 High Fructose Corn Syrup in bulk tank
shipments. Recall #F-039-2.
Code: Bulk shipments made on 10-15-91, 10-16-91, 10-17-91,
10-18-91.
Manufacturer: A.E. Staley Manufacturing Co., Decatur, Illinois.
Recalled by: Manufacturer, by telephone October 18, 1991.
Firm-initiated recall ongoing.
Distribution: Missouri, Kentucky, Michigan, Wisconsin, Indiana, Illinois.
Quantity: 31 shipments of approximately 47,000 pounds each were
distributed; firm estimates 75% of the product remains
on the market.
Reason: Product contains high sulfite levels.
-----
Product: Bottled Spring Water, in 8 ounce bottles.
Recall #F-041-2.
Code: RD1641 and 1631.
Manufacturer: West Virginia Spring Water Company, Berkeley Springs,
West Virginia.
Recalled by: Manufacturer, by letter September 29, 1991. Firm-
initiated recall ongoing.
Distribution: North Carolina.
Quantity: 936 cases (12 bottles per case) were distributed.
Reason: Product is contaminated with mold.
----
-2-
Product: Spring Water packaged under the following labels:
Monadnock Mountain Water, Inc. (Naturally Sodium Free),
Mountain Spring, Idelnot Spring Water, Shop 'N save 100%
Natural Spring Water, Shaw's Spring Water, Farm Fare Natural
Spring Water, Crystal Spring Water, and Buck Natural
Spring. Recall #F-042-2.
Code: (1206-1220). Product manufactured between July 25, and
August 8, 1991.
Manufacturer: Idlenot Farm Dairy, Inc., Wilton, New Hampshire.
Recalled by: Manufacturer, by telephone and FAX September 6, 1991,
followed by letter September 7, 1991. Firm-initiated
recall ongoing.
Distribution: New Hampshire, Massachusetts, Vermont.
Quantity: Approximately 19,500 gallons were distributed.
Reason: Off odor and off taste due to tetrahydrofuran.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Phentermine HCl Capsules, USP, 30 mg, in bottles of
100, a Rx controlled drug used for management of exogenous
obesity as a short term adjunct (few weeks).
Recall #D-018-2.
Code: Lot #B3303 EXP 7/93.
Manufacturer: Rexar Pharmacal Corporation, Valley Stream, New York.
Recalled by: Manufacturer, by letter August 27, 1991. Firm-initiated
recall ongoing.
Distribution: Pennsylvania.
Quantity: Approximately 2,976 bottles were distributed.
Reason: The label does not bear the required symbol for controlled
substances.
----
Product: Suprax - Cefixime Powder for oral suspension, 100 mg,
5 ml in 75 ml bottle, an Rx antibiotic.
Recall #D-020-2.
Code: 313-306, 313-307, 313-308, 313-310.
Manufacturer: Biocraft Laboratories, Inc., Elmwood Park, New Jersey.
Recalled by: Lederle Laboratories, Pearl River, New York, by
letter on or about October 30, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
-3-
Quantity: 10,582 bottles were distributed; firm estimates little
stock remains on the market.
Reason: The carton and bottle label incorrectly declare the
contents as 1 gram instead of 1.5 grams.
----
Product: (a) Diazepam Tablets, 2 mg, 5 mg and 10 mg, in bottles
of 100 and 500 unit dose packaging 10 x 10 and 4 x 25;
(b) Methyldopa Tablets, 250 mg in bottles of 100 and
1,000 and 500 mg in bottles of 100 and 500;
(c) Verapamil HCl Tablets, 80 mg in bottles of 100 and
500 and 120 mg in bottles of 100 and 500. All have
the Warner Chilcott blue print on white labels and
are Rx designated. Recall #D-021/027-2.
Code: All products with expiration date of 10/91 or later.
(a) 2 mg: N 0047-0141-24, 30, 40, 41;
5 mg: N 0047-0142-24, 30, 40, 41;
10 mg: N 0047-0143-24, 30, 40, 41;
(b) 250 mg: N 0047-0865-24, 32;
500 mg: N 0047-0866-24, 30;
(c) 80 mg: N 0047-0557-24, 30;
120 mg: N 0047-0573-24, 30.
Manufacturer: Warner Chilcott Division, Warner-Lambert Company,
Morris Plains, New Jersey.
Recalled by: Manufacturer, by letter September 23, 1991. Firm-
initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 2 mg: 7,829,300 tablets;
5 mg: 44,583,000 tablets;
10 mg: 14,981,600 tablets;
(b) 250 mg: 9,741,300 tablets;
500 mg: 4,039,800 tablets;
(c) 80 mg: 21,691,000 tablets;
120 mg: 5,554,900 tablets were distributed.
Reason: Current good manufacturing practice deficiencies.
----
Product: (a) Otrivin Nasal Spray, 0.1%, 15 mL (Xylometazoline HCl,
USP);
(b) Otrivin Nasal Drops, 0.1%, 20 mL (Xylometazoline HCl,
USP);
(c) Otrivin Pediatric Nasal Drops, 0.05%, 20 mL
(Xylometazoline HCl, USP);
(d) Privine Nasal Solution, 0.05%, 20 mL (Naphazoline HCl,
USP);
(e) Privine Nasal Spray, 0.05%, 15 mL (Naphazoline HCl, USP);
All are OTC products administered to the nasal mucosa for
temporary relief of nasal congestion. Recall #D-029/033-2.
-4-
Code: All lot numbers of the following five products:
CCP Product NDC Code Size
(a) 2701 0028-6188-57 15 mL
(b) 2704 0028-6114-58 20 mL
(c) 2705 0028-6116-58 20 mL
(d) 6529 0083-6511-58 20 mL
(e) 6533 0083-6534-57 15 mL
Manufacturer: Ciba-Geigy Pharmaceuticals Division, Summit, New
Jersey.
Recalled by: CIBA Consumer Pharmaceuticals, Edison, New Jersey, by
letter April 29, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Total Privine 2,403,700 (excluding pints);
Total Otrivin 1,384,500.
Total amounts of both products, estimated, that remained on
the market, at the initiation of the recall were 399,800
units (from 1990) and 179,000 units (from 1991), totaling
578,000 units.
Reason: Product leakage and evaporation due to package closure
deficiencies in some bottles.
----
Product: Brethine 5 mg Tablets, in 100 tablet bottles and
in 100 tablet unit dose blister pack, a bronchodilator
for oral administration. Recall #D-034-2.
Code: Lot numbers: 1B122240 EXP 10/94, (100 tablet bottles),
2B122240 EXP 10/94 (unit dose pack), B122240 (bulk).
Manufacturer: Ciba-Geigy Pharmaceuticals, Division of Ciba-Geigy
Corporation, Summit, New Jersey.
Recalled by: Manufacturer, by letter July 8, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 20,148 100-tablet bottles and 21,046 unit dose blister
packs were distributed.
Reason: An Acutrim tablet core was found in a unit dose blister
pack of Brethine tablets.
----
Product: Whole Blood. Recall #B-036-2.
Code: Unit #AT3810.
Manufacturer: Blood Bank of Alaska, Anchorage, Alaska.
Recalled by: Manufacturer, by telephone August 2, 1991.
Firm-initiated recall complete.
Distribution: Alaska.
Quantity: 1 unit.
Reason: Blood product, untested for hepatitis B surface antigen
(HBsAg), but labeled as nonreactive for HBsAg, was
distributed.
----
-5-
Class III -
Product: Medical Air, USP, distributed in type "E" cylinders.
Recall #D-016-2.
Code: Lot number 6000G112.
Manufacturer: AGA Gas, Inc., Twinsburg, Ohio.
Recalled by: Manufacturer, by visit July 15, 1991. Firm-initiated
recall complete.
Distribution: Ohio.
Quantity: 15 cylinders were distributed.
Reason: Product does not meet specification for CO2 content.
----
Product: Kasdenol 10 gram in amber glass bottles, a germicidal
mouth wash and gargle. Recall #D-017-2.
Code: Lot #KA0220 EXP 2/92.
Manufacturer: United Guardian, Inc., Hauppague, New York.
Recalled by: Manufacturer, by letter July 15, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 5,186 units were distributed.
Reason: Available chlorine is below specification.
----
Product: Terpin Hydrate and Codeine Elixir USP, 4 ounce, in
16 ounce, and 128 ounce bottles, under Halsey's
Blue Cross label. Recall #D-019-2.
Code: Lot numbers: 45099, 45149, 45208, 45209, 45238,
45237, 45256, 45289, 45089.
Manufacturer: Halsey Drug Co., Brooklyn, New York.
Recalled by: Manufacturer, by letter October 10, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 224,376 4-oz bottles, 17,294 16-oz bottles, and 776
128-oz bottles were distributed.
Reason: Product marketed not in accordance with CFR Part 341.
----
Product: Theodrine Tablets, antiasthmatic, in 100 and 1,000
tablet bottles. Recall #D-028-2.
Code: Lot numbers: 902NC083 EXP 2/92, 008NC020 EXP 8/92,
010NC020 EXP 11/92, 011NC001 EXP 11/92, 012NC030
EXP 12/92.
Manufacturer: Chelsea Laboratories, Inc., Monroe, North Carolina.
Recalled by: Rugby Laboratories, Inc., Rockville Center, New York,
by letter July 24, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
-6-
Quantity: LOT # PACKAGE SIZE DISTRIBUTED AMT ON MKT
902NCO83 100 12,290 BTLS 12,289 BTLS
1000 200 BTLS 200 BTLS
008NCO20 100 11,235 BTLS 11,234 BTLS
1000 323 BTLS 324 BTLS
010NC020 100 8,810 BTLS 8,803 BTLS
1000 600 BTLS 596 BTLS
011NC001 100 7,875 BTLS 7,086 BTLS
1000 675 BTLS 562 BTLS
012NC030 100 9,768 BTLS 9,768 BTLS
1000 486 BTLS 472 BTLS
Reason: Product may not meet dissolution specifications through
expiration date.
----
Product: Dyazide Capsules (Triamterene 50 mg, Hydrochlorothiazide
25 mg), in bottles of 1,000 and for professional samples
in packages of 30, 2 x 4's, 1 x 4's and 100's, a Rx
diuretic anti-hypertensive. Recall #D-035-2.
Code: Lot numbers: 1296E90, 37E90, 57E90, 67E90, 197E90, 267E90,
307E90, 387E90, 417E90, 517E90, 957E90, 1377E90, 28E90,
68E90, 148E90, 208E90, (REGULAR PRODUCTION) AND 67E90,
1377E90, 168E90 (30'S), 168E90, (2 X 4'S) (PHYSICIAN
SAMPLES).
Manufacturer: Smithkline Beecham Pharmaceuticals Company, Cidra,
Puerto Rico.
Recalled by: Manufacturer, by letter November 1, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates none remains on the market.
Reason: Product does not meet dissolution specifications.
----
Product: Literature associated with Bacdown Handsoap.
Recall #D-036-2.
Code: None.
Manufacturer: Decon Laboratories, Inc., Bryn Mawr, Pennsylvania.
Recalled by: Manufacturer, by electronic message September 9, 1991
followed by letter mailed November 1, 1991. Firm-
initiated field correction ongoing.
Distribution: New Jersey, Massachusetts, England.
Quantity: Approximately 200 reprints were distributed.
Reason: Promotional literature misbrands the product.
----
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
-7-
Class II -
Product: 15 Coburn Intraocular Lenses (IOLs), various powers,
sizes, and focal lengths. Recall #Z-058-2.
Code: Control Model Diopter Length
I04733 -120UV +25.5 13.75 mm
I37735 -72 +17.5 13.75 mm
K12213 -72 +17.5 13.75 mm
K12215 -72 +17.5 13.75 mm
K12219 -72 +17.5 13.75 mm
K12220 -72 +17.5 13.75 mm
L42902 -120 +18.0 12.75 mm
M63013 -121UV +23.0 13.75 mm
N13123 -90 -14.0 12.50 mm
N61916 -121UV +11.5 13.75 mm
N61930 -121UV +11.5 13.75 mm
P20931 -107UV +17.0 13.75 mm
Q57335 -121UV +20.5 13.75 mm
W49908 -120UV +19.0 13.75 mm
1K8365 -121 +20.0 13.75 mm.
Manufacturer: Storz Ophthalmics, Inc., Clearwater, Florida.
Recalled by: Manufacturer, by letter May 14, 1991. Firm-initiated
recall ongoing.
Distribution: New York, Michigan, California, Florida, Maine, Utah,
Maryland, Germany, Sweden.
Quantity: 15 lenses were distributed.
Reason: Implantation of a lens could result in refractive
error or mis-sizing of the lens.
----
Product: Visiguide/79 JR4 S Judkins Type Right 4 Coronary w/Side
holes Softip Guiding Catheters, length 100 cm, 8 French.
Recall #Z-059-2.
Code: Lot MGA912803.
Manufacturer: Schneider (USA), Inc., Plymouth, Minnesota.
Recalled by: Manufacturer, by telephone beginning September 25, 1991,
followed by letter. Firm-initiated recall complete.
Distribution: Arkansas, California, Connecticut, Georgia, Louisiana,
Maine, Massachusetts, New Hampshire, New Jersey, New York,
North Carolina, Texas, Wisconsin.
Quantity: 110 units were distributed.
Reason: The catheter is labeled as having side holes, but does
not have the side holes.
----
Class III -
Product: 4C Plus Abnormal Low Coulter Counter Cell Control:
3 ml Lot 613 Exp. Date April 8, 1991 (Product
is packaged in kits only). Recall #Z-060-2.
-8-
Code: (A) 4C Plus Abnormal Low Cell Control
9x3 ml, Lot 613F;
(B) 4C Plus Tripack Cell Control 9x3 ml
Lots 103339K, 103340K;
(C) 4C Plus Tripack Cell Control 6x3 ml
Lot 108119K.
Manufacturer: Coulter Diagnostics, Hialeah, Florida.
Recalled by: Manufacturer, by letter March 18, 1991. Firm-initiated
recall complete.
Distribution: Nationwide and international.
Quantity: 95 kits of lot 613F, 1,521 kits of lot 103339K,
730 kits of lot 108119K and 2,003 kits of lot 103340K
were distributed; firm estimates none remains on the
market.
Reason: The control was assayed before it had stabilized which
may result in high mean cell volume values.
----
Product: 4C Plus Abnormal High Coulter Counter Cell Control:
1. 3 ml Lot 824 EXP June 24, 1991 (Product is packaged
in kits only)
(A) 4C Plus Abnormal High Cell Control 9x3.3 ml
(B) 4C Plus Tripack Cell Control 6x3.3 ML
2. 6 ml Lot 4455 EXP June 16, 1991 (Product is
package in kits only); 4C Plus Abnormal High/Low Cell Control
3. 3 ml Lot 811 EXP April 7, 1991 (Product is packaged
in kits only)
(A) 4C Plus Abnormal High Cell Control 9x3 ml
(B) 4C Plus Tripack Cell Control 9x3 ml
(C) 4C Plus Tripack Cell Control 6x3 ml
4. 3.3 ml Lot 822 EXP June 12, 1991 (Product is
packaged in kits only)
(A) 4C Plus Abnormal High Cell Control
9x3.3 ml. Recall #Z-061/064-2.
(B) 4C Plus Tripack Cell Control 9x3.3 ml
(C) 4C Plus Tripack Cell Control 6x3.3 ml
Code: 1. (A) Lots 103367K, 103368K;
(B) Lot 108134K;
2. Lot 28168K;
3. (A) Lot 811F (1 Level of Control);
(B) Lots 103336K, 103337K, 103338K, (3 Levels
of Controls);
(C) Lot 108118K.
4. (A) Lot 822F, 822Fl;
(B) Lots 103363K, 103364K;
(C) Lot 108131K, 108132K.
Manufacturer: Coulter Diagnostics, Hialeah, Florida.
Recalled by: Manufacturer, by letters of April 5, 1991 and June 5, 1991.
Firm-initiated recall complete.
Distribution: Nationwide and international.
-9-
Quantity: Firm estimates none remains on the market.
Reason: The control was assayed before it had stablizied which may
result in low red cell distribution width values.
----
VETERINARY PRODUCTS
NONE
Seizure Actions Filed:
Product: Crab Meat (91-575-080).
Charge: Adulterated - Product was picked and packed under
insanitary conditions whereby it may have become
contaminated with filth.
Firm: Fish Market, Inc., Bayou LaBatre, Alabama.
Filed: October 29, 1991 - U.S. District Court for the
Southern District of Alabama; Civil #91-0876-AH-S,
FDC #66300.
-10-
###