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
09/08/1993
Recalls and Field Corrections: Foods -- Class I -- 09/08/1993
SEPTEMBER 8, 1993 93-36
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
=========================
_______________
PRODUCT Laurel's Heart brand Garlic Spread in 4 ounce glass bottles,
(a) Hellfire Garlic Spread; (b) Wildfire Garlic Spread (c)
Mildfire Garlic Spread. Recall #F-615/617-3.
CODE None.
MANUFACTURER Laurel's Heart, Shingle Springs, California.
RECALLED BY Laurel's Heart, Sacramanto, California, by telephone July
17, 1993, and letter July 19, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION California, Delaware, Missouri.
QUANTITY 462 bottles were distributed.
REASON The product has the potential to support the growth of
Clostridium botulinum toxin.
_______________
PRODUCT Kroger and Fry brand Canned Gravies (a) Chicken Gravy; (b)
Brown Gravy; (c) Mushroom Gravy; (d) Turkey Gravy, packed in
13.5 ounce cans. Recall #F-618/621-3.
CODE All codes.
MANUFACTURER Kroger State Avenue Manufacturing, Cincinnati, Ohio.
RECALLED BY The Kroger Company, Cincinnati, Ohio, via electronic mail to
their five regional offices, June 30, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Unknown.
REASON The product has the potential to support the growth of
Clostridium botulinum toxin.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
======================
_______________
PRODUCT Wegmans brand Blueberry Waffles, frozen, net weight 16.5
ounces. Recall #F-573-3.
CODE All lots in distribution prior to 6/11/93.
MANUFACTURER Western Waffles Ltd., Richmond, B.C., Canada.
RECALLED BY Wegmans Food Markets, Inc., Rochester, New York, by letter
June 11, 1993. Firm-initiated recall complete.
DISTRIBUTION Western and Central New York State.
QUANTITY Unknown.
REASON The product contains undeclared FD&C Red No. 2, Red No. 40
and Blue No. 1.
_______________
PRODUCT Dorman's Lo-Chol Swiss Cheese Alternative, Slices, less than
5 mg. of cholesterol per ounce, net weight 5 ounces, and 12
pound loaves. Recall #F-580/581-3.
CODE A25 JUL 932M (5 ounce package); 7/22/93 (12 pound loaf).
MANUFACTURER Dorman-Roth Foods, Inc., Monroe, Wisconsin.
RECALLED BY Dorman-Roth Foods, Inc., Hasbrouck Heights, New Jersey, by
telephone April 8, 1993, followed by letter April 9, 1993.
Firm-initiated recall complete.
DISTRIBUTION New York, New Jersey.
QUANTITY 281 cases (12 5-ounce packages and 25 12-pound loaves) were
distributed; firm estimates none remains on the market.
REASON Product contains metal pieces.
_______________
PRODUCT Sage Drink (Chan Refresco Especial) in 12 ounce packages.
Recall #F-583-3.
CODE None.
MANUFACTURER Associated Distributors, Inc., Beltsville, Maryland.
RECALLED BY Manufacturer by letter May 11, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Maryland, Washington, D.C., Northern Virginia, New York.
QUANTITY 80/12 ounce packages were distributed.
REASON Product contains FD&C Red No. 2, an unapproved color
additive.
_______________
PRODUCT Calcium with Vitamin D Tablets under the labels: (a) Vitamin
Classics, (b) Sonergy, (c) Spring Valley. Recall #F-610-3
CODE (a) 205141A, 205141B, 205141C, 224155B; (b) 231074A; (c)
218849A, 218849B, 218849C, 230691A, 230691C.
MANUFACTURER Nion Laboratories, Irwindale, California.
RECALLED BY Amcon Industries, Buena Park, California, by telephone and
fax March 25, 1993. Firm-initiated recall ongoing.
DISTRIBUTION (a) Arizona, California, Illinois, Ohio, Utah, Washington
state, (b) California, (c) Colorado, Florida, Georgia,
Illinois, Michigan, New York, Texas.
-2-
QUANTITY (a) 2,508 bottles; (b) 300 bottles; (c) 12,488 bottles were
distributed.
REASON The product contains Vitamin D at ten times the amount
indicated on the label.
_______________
PRODUCT Hot Corn Drink (Shuco Athol Especial) in 12 ounce packages.
Recall #F-612-3.
CODE None.
MANUFACTURER Associated Distributors, Inc., Beltsville, Maryland.
RECALLED BY Manufacturer by letter May 11, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Maryland, Washington, D.C., Northern Virginia, New York.
QUANTITY 100/12 ounce packages were distributed.
REASON Product contains FD&C Red No. 2, an unapproved color
additive.
_______________
PRODUCT Picarindo brand Tamarind Fruit Candy, a snack for children
in 5.5 ounce net weight ceramic jar. Recall #F-609-3
CODE All lots.
MANUFACTURER Alfredo Zacarias Fiqueroa, Morelia, Michigan.
RECALLED BY Dulceria El Molino Import & Export, City of Commerce,
California. The State of California Food and Drug Unit
issued a press release warning the public on May 5, 1993,
with follow-up letter on May 19, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION California.
QUANTITY 132 cases were distributed.
REASON Product contains excessive levels of lead.
_______________
PRODUCT Himalayan Brand Apricot Kernels in 8 ounce bags, Recall #F-
622-3.
CODE C12120.
MANUFACTURER R.S. Organic Imports, Inc. (responsible firm), North
Tarrytown, New York.
RECALLED BY Manufacturer by letter in mid March, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION New York, Washington state, Florida, Massachusetts,
Connecticut, Pennsylvania, Ohio, Virgin Islands.
QUANTITY 50/8 ounce bags were distributed.
REASON The product contains excessive levels of cyanide.
-3-
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
======================
_______________
PRODUCT Various brands Red Grape Juice (a) Grape Juice from
Concentrate with Vitamin C; (b) Grape Juice from
Concentrate; (c) Grape Juice, Unsweetened, in 32, 40, 46
ounce and 64 ounce bottles. Recall #F-577/579-3.
CODE "CT 314 ____04/16/94" and EARLIER CODES (e.g. CT 314 ___
12/20/92.
MANUFACTURER Spear Packing Corporation, New Brunswick, New Jersey.
RECALLED BY Manufacturer, by telephone and letter April 23 and 26, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Alabama, Florida, Illinois, Massachusetts, Maryland,
Michigan, Mississippi, North Carolina, New Jersey, New York,
Ohio, Pennsylvania, South Carolina, Tennessee, Virginia.
QUANTITY 63,861 cases were distributed. Firm estimates 300 bottles
remain in the marketplace.
REASON Products contain undeclared ingredients.
_______________
PRODUCT Barley Drink ("LYA" Salvadorena Powdered Drink Mix) in 12
ounce packages. Recall F-584-3.
CODE None.
MANUFACTURER Associated Distributors, Inc., Beltsville, Maryland.
RECALLED BY Manufacturer by letter on or about May 11, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Maryland, Washington, D.C., northern Virginia, New York.
QUANTITY 35 cartons/12 ounce packages were distributed.
REASON Product contains FD&C Red No. 40, which is not declared on
label.
_______________
PRODUCT "Cuzcatlan" Instant Refreshment of Chang in 12 ounce
packages. Recall #F-613-3.
CODE None.
MANUFACTURER Associated Distributors, Inc., Beltsville, Maryland.
RECALLED BY Manufacturer by letter on or about May 11, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Maryland, Washington, D.C., Northern Virginia, New York.
QUANTITY 40 packages were distributed.
REASON Product contains FD&C Red No. 40, which is not declared on
label.
-4-
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=======================
_______________
PRODUCT Ethex brand Nitroglycerin Extended-Release Capsules, 9 mg.,
packaged in 60 capsule and 100 capsule bottles, for the
prevention of angina pectoris due to coronary artery
disease. Recall #D-329-3.
CODE V2593, exp. 12/95; V2905, exp. 2/95; V2707 exp. 1/96.
MANUFACTURER KV Pharmaceutical Company, St. Louis, Missouri.
RECALLED BY Ethex Corporation, St. Louis, Missouri, by letter August 19,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 927 cases/12 bottles per case/60 capsule bottles; 550
cases/12 bottles per case/100 capsule bottles were
distributed.
REASON Lack of adequate assurance of potency through expiration
date and process validation.
_______________
PRODUCT Colchicine Tablets USP 0.6 mg, in 100, 250 and 1000 tablets
per bottle, used for the treatment of gout. Recall
#D-331-3.
CODE Lot numbers: 2047-802, exp. date 8/93; 2047-806, exp. date
8/93; 2047-807, exp. date 9/93; 2047-808, exp. date 9/93;
2047-809, exp. date 10/93; 2047-810, exp. date 10/93; 2047-
811, exp. date 11/93; 2047-812, exp. date 12/93; 2047-813
exp. date 11/93; 2047-814, exp. date 12/93.
MANUFACTURER Zenith Laboratories Caribe, Inc., Cidra, Puerto Rico.
RECALLED BY Manufacturer by letter August 16, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 11,155,219 tablets were distributed.
REASON Potency not assured through expiration date.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
====================
_______________
PRODUCT Triamcinolone Acetonide 0.05% in Absorbase, in 1 pound
plastic jars. Recall #D-330-3.
CODE All lots.
MANUFACTURER Carolina Medical Products Co., Farmville, North Carolina.
RECALLED BY Manufacturer by letter August 25, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION North Carolina.
QUANTITY Firm estimates 300/1 pound jars remain on market.
REASON Product marketed without ANDA approval.
-5-
_______________
PRODUCT Epi Pen, 0.3 mg. Epinephrine Auto-Injector, an Rx drug used
for allergic emergencies (anaphylaxis). Recall #D-332-3.
CODE 1SX032 Exp. OCT 93.
MANUFACTURER Survival Technology, Inc., St. Louis, Missouri.
RECALLED BY Survival Technology, Inc., St. Louis, Missouri, Center
Laboratories/Division of EM Pharmaceuticals, Inc., Port
Washington, New York, by letter July 12, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 9,754 units were distributed.
REASON Marginally subpotent.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
==================
_______________
PRODUCT "Blood Bank Donor" Computer Software Module.
Recall #B-184-3.
CODE Versions 302 and 303.
MANUFACTURER Cerner Corporation, Kansas City, Missouri.
RECALLED BY Manufacturer by letter June 29, 1990. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY Nine blood banks using version 302 and sixteen blood banks
using version 303 were distributed.
REASON Computer software, containing a design defect that
could result in the assignment of incorrect ABO and Rh
groups, was distributed.
_______________
PRODUCT Recovered Plasma, Recall #B-359-3
CODE Units numbers: A21838, A22033, A22066, A22135, A22137,
A22155, A22184, A22207, A22234, A22245, A22309, A22346,
A22371, A30030, A30059, A300068, A30087, A30101, A30111,
A30114, A30159, A30183, A30184, A30195.
MANUFACTURER Southern California Permanente Medical Group/dba Kaiser
Foundation Blood Donor Center, San Diego, California.
RECALLED BY Manufacturer by telephone March 11, 1993 and by letter March
17, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Florida, California.
QUANTITY 24 units were distributed.
REASON Recovered Plasma, collected from autologous donors who did
not meet the following suitability requirements for
allogeneic use was distributed or: 1) reported histories of
hepatitis or jaundice; 2) exhibited signs or symptoms of
AIDS; 3) reported recent tattoos, ear piercing or
acupuncture treatment; 4) reported receiving an allogeneic
transfusion within the twelve months prior to donating; 5)
reported a history of cancer; 6) reported current use of
medications.
-6-
_______________
PRODUCT Red Blood Cells, Recall #B-393-3.
CODE Unit number 3274952.
MANUFACTURER Michigan Community Blood Center, Saginaw, Michigan.
RECALLED BY Manufacturer by telephone and letter August 23, 1991 with
follow-up letter. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product collected from an ineligible donor, previously
deferred for ear piercing by a non-sterile method, was
distributed.
_______________
PRODUCT Recovered Plasma, Recall #B-395-3.
CODE Unit number 12FC56373.
MANUFACTURER American Red Cross Blood Services, Charlotte, North
Carolina.
RECALLED BY Manufacturer by facsimile April 1, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product, collected from a donor who provided a history
of treatment for gonorrhea in the previous twelve months,
was distributed.
_______________
PRODUCT (a) Red Blood Cells, (b) Fresh Frozen Plasma, (c) Recovered
Plasma. Recall #B-417/419-3.
CODE Unit numbers: (a) 0244829; (b) 0244829; (c) 0246920.
MANUFACTURER Inland Northwest Blood Center, Spokane, Washington.
RECALLED BY Manufacturer by letters March 31 and April 4, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Washington state, Idaho, Missouri.
QUANTITY 3 units were distributed.
REASON Blood products, collected from a donor who provided a
history of self-injected drug use, were distributed.
_______________
PRODUCT Red Blood Cells, Washed. Recall #B-423-3.
CODE Unit numbers: 25FG15052, 25V28342.
MANUFACTURER American Red Cross Blood Services, Syracuse, New York.
RECALLED BY Manufacturer by telephone November 30, 1992, with follow-up
letter dated December 3, 1992. Firm-initiated recall
complete.
DISTRIBUTION New York.
QUANTITY 2 units were distributed.
REASON Blood products, labeled with incorrect expiration dates,
were distributed.
-7-
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
==================
_______________
PRODUCT Recovered Plasma. Recall #B-360-3
CODE Unit numbers: A21987, A22019, A22187, A22224, A22269,
A22272, A22277, A22340.
MANUFACTURER Southern California Permanente Medical Group/dba Kaiser
Foundation Blood Donor Center, San Diego, California.
RECALLED BY Manufacturer by telephone March 11, 1993, and letter March
17, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Florida, California.
QUANTITY 8 units were distributed.
REASON Recovered Plasma, collected from autologous donors who did
not meet the following suitability requirements for
allogeneic use were distributed: 1) reported histories of
hepatitis or jaundice; 2) exhibited signs or symptoms of
AIDS; 3) reported recent tattoos, ear piercing or
acupuncture treatment; 4) reported receiving an allogeneic
transfusion within the twelve months prior to donating; 5)
reported a history of cancer; or 6) reported current use of
medications.
_______________
PRODUCT Dry Cryoprecipitated AHF. Recall #B-420-3.
CODE Unit numbers: 36M26282, 36M26293, 36M26304, 36M26307,
36M26319.
MANUFACTURER American Red Cross Blood Services, Columbia, South Carolina.
RECALLED BY Manufacturer by telephone February 23, 1993, with follow-up
letter March 11, 1993.
DISTRIBUTION Georgia.
QUANTITY 5 units were distributed.
REASON Unlicensed blood products were distributed in interstate
commerce.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
====================
_______________
PRODUCT Wound Clip Applicator for Endoscopic Surgical Use, used to
staple wounds after surgery. Recall #Z-637-3.
CODE None.
MANUFACTURER Olympus Optical Company, Ltd., Tokyo, Japan.
RECALLED BY Olympus Corporation, Lake Success, New York, by telephone
March 5, 1992. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY Firm estimates none remain on market.
REASON The metal ring in the device was manufactured backwards and
the clip does not release in surgery.
-8-
_______________
PRODUCT (a) Angled dissecting forceps (10 millimeter/unipolar) Cat.
#A5630 and (b) Coagulating dissecting forceps (05
millimeter/unipolar) Cat. #A5638. Recall #Z-638-3.
CODE Model #'s C0030 and C0038.
MANUFACTURER Cuda, Jacksonville, Florida.
RECALLED BY Olympus Corporation, Lake Success, New York by letter
January 15, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 705 units, (b) 1,385 units.
REASON The handle portion of the product has inadequate insulation
to prevent electrical current leakage to the clinician when
performing electrosurgical procedures at a high power
setting.
_______________
PRODUCT (a) Model GF-UM20 Endoscope, Ultrasound; (b) Model JF-UM20
Endoscope, Ultrasound; (c) Model CF-UM20 Endoscope,
Ultrasound. Recall #Z-674/676-3.
CODE All lots.
MANUFACTURER Olympus Optical Company, Ltd., Tokyo, Japan.
RECALLED BY Olympus Corporation, Lake Success, New York, by letter
November 3, 1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 26 units were distributed.
REASON The internal o-ring could lose its ability to seal properly
causing the balloon to inflate with water.
_______________
PRODUCT USCI Goetz Bipolar Electrode, 6 F, 125 CM, used to transmit
stimulus from the pulse generator to the heart and/or a
packing electrical signal from the heart to a recording
device. Recall #Z-695-3.
CODE Lot number 07DC0649.
MANUFACTURER USCI Division C.R. Bard, Inc., Glens Falls, New York.
RECALLED BY USCI Division C.R. Bard, Inc., Billerica, Massachusetts by
telephone with follow-up letter dated January 5, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION California, Colorado, Georgia, Louisiana, Minnesota, New
York, Illinois, Texas, Florida, Pennsylvania, Virginia.
QUANTITY 130 units were distributed.
REASON A single lot of Goetz Bipolar Electrode was mislabeled as
USCI NBIH Bipolar Electrodes, Item no. 007157, Lot 07DC0645,
on the inner pouch that protects each electrode. However,
the outer box that contains five individually pouched
electrodes was correctly labeled as USCI Goetz Bipolar
Electrodes.
-9-
####