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
11/22/1995
ENFORCEMENT REPORT FOR 11/22/95
November 22, 1995 95-47
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Egg Bagels (frozen), packaged 6 bagels per plastic bag.
Recall #F-034-6.
CODE All lots currently in market; cases coded 42163, individual
plastic bags coded 42198.
MANUFACTURER Sir Bagel, Concord, Ontario, Canada.
RECALLED BY Rich Products Corporation, Buffalo, New York, by memorandum
dated September 20, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,189 cases (16 retail units per bag) were distributed.
REASON Product contains undeclared eggs and FD&C Yellow #5.
_______________
PRODUCT Garlic Olive Oil, in 12.7 ounce glass bottles.
Recall #F-052-6.
CODE None.
MANUFACTURER St. Gregory's Retreat Center and Farm, Mexico, New York.
RECALLED BY Manufacturer, by telephone on June 4, 1995, followed by
visit. FDA-initiated recall complete.
DISTRIBUTION New York, New Jersey.
QUANTITY 90 bottles were distributed.
REASON The garlic clove in the product has the potential to support
the growth of Clostridium botulinum spores but there is
moderate likelihood that this would pose a hazard to health.
_______________
PRODUCT Hot Stuffed Peppers under the La Frede Deluxe and Pasta
Fresca labels, in 16 ounce and 32 ounce glass jars.
Recall #F-053-6.
CODE None.
MANUFACTURER Pasta Fresca, Brooklyn, New York.
RECALLED BY Cannillo's Importers and Wholesale Grocers, Passaic, New
Jersey, by letter dated July 25, 1995. Firm-initiated
recall complete.
DISTRIBUTION New Jersey and New York.
QUANTITY 62 cases (12 16-ounce jars per case) and 10 cases (12 32-
ounce jars per case) were distributed.
REASON The manufacturer of the product did not register and file a
scheduled process for this Acidified and Low Acid Canned
Food (ALACF) product as required by 21 CFR Part 108.25 and
did not comply with mandatory provisions of 21 CFR Part 114.
_______________
PRODUCT Baker's Harvest Original Style Sesame Wheat Snack Crackers,
packaged in 8 ounce boxes. Recall #F-055-6.
CODE 1P212U and 1P262W.
MANUFACTURER Bremner, Inc., Princeton, Kentucky.
RECALLED BY Bremner, Inc., St. Louis, Missouri, by verbal notification
and by letter September 29, 1995. Firm-initiated recall
complete.
DISTRIBUTION Oregon, California, Utah.
QUANTITY Approximately 2,196 12-box cases were distributed.
REASON Product contained undeclared FD&C Yellow No. #5 and #6.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Dessaux Amora Red Wine Vinegar Aged in Wood in 1 L (33.8
fluid ounce) plastic bottles. Recall #F-054-6.
CODE C. 3747.
MANUFACTURER Amora, France.
RECALLED BY KDI Specialty Foods, Inc., Deer Park, New York, by letter
dated October 17, 1995. FDA-initiated recall ongoing.
DISTRIBUTION New York, New Jersey, Massachusetts, Delaware, New
Hampshire, Vermont, Connecticut, Pennsylvania, North
Carolina, Maryland, Virginia.
QUANTITY 97 cases (12 bottles per case) were distributed.
REASON Product contains undeclared sulfites.
_______________
UPDATE Recall #F-048/051-6, Rising Sun Farm brand Salad Vinaigrette
and Marinades in 12.5 fluid ounce glass jars, which appeared
in the November 15, 1995 Enforcement Report should read:
Firm-initiated recall complete.
-2-RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT SLO-BID 50 mg and SLO-BID 75 mg (Theophylline, extended
release capsules, USP), Rx bronchodilator.
Recall #D-017/018-6.
CODE Lot #MN1468 EXP 7/99 and Lot MN1509 EXP 8/99.
MANUFACTURER Rhone-Poulenc Rorer Pharmaceuticals, Inc., Collegeville,
Pennsylvania.
RECALLED BY Manufacturer, by letter dated November 3, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that 10,238 units of lot MN1509 and 17,448
units of lot MN1468 remained on market at time of recall
initiation.
REASON A small number of capsules were found low filled.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Zestril (Lisinopril) 20 mg, physician samples, indicated for
the treatment of hypertension. Recall #D-019-6.
CODE Lot #4127T EXP 9/1/97.
MANUFACTURER Zeneca Pharmaceuticals, Wilmington, Delaware.
RECALLED BY Manufacturer, by voice mail message on September 29, 1995,
followed by letter dated October 3, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY Firm estimates none remains on the market.
REASON A small number of tablets may contain metal particles.
_______________
PRODUCT CIS-DTPA, kit for the preparation of TC 99m Pentetate 10 ml
vial, for diagnostic use by intravenous injection.
Recall #D-020-6.
CODE Lot numbers: 2302, 2303, and 2304.
NOTE: Lot #2302 and #2303 distributed under CIS label Lot
#2304 distributed under Mallinckrodt label.
MANUFACTURER CIS-US, Inc., Bedford, Massachusetts.
RECALLED BY Manufacturer, by letter dated October 23, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 9,755 vials of lot 2302, 3,185 vials of lot 2303, and 7,440
vials of lot 2304 were distributed.
REASON Product exceeds specification for moisture content.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Platelets. Recall #B-063-6.
CODE Unit #53GZ73217.
MANUFACTURER American Red Cross, Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated February 7, 1995. Firm-
initiated recall complete.
-3-DISTRIBUTION Maryland.
QUANTITY 1 unit.
REASON Blood product, corresponding to Red Blood Cells which was
contaminated with a gram positive coccus suspected to be
Staphylococcus epidermidis, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-067-6.
CODE Unit #40LW03094.
MANUFACTURER American National Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by letter dated July 28, 1995. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product, which was collected from a donor who had
emigrated from an area designated as endemic for malaria,
was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-068-6.
CODE Unit numbers: 40FG27244 and 40FG27581.
MANUFACTURER American National Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by letters dated August 2, 1995. Firm-
initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 2 units.
REASON Blood product, which was collected from a donor who had
visited an area designated as endemic for malaria, was
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated
AHF; (d) Single Donor Plasma; (e) Recovered Plasma; (f)
Platelets, for further manufacture; (g) Fresh Frozen Plasma,
for further manufacture. Recall #B-069/075-6.
CODE Unit numbers: (a) 53GH28576, 53GH28149, 53FK13077,
53FK11578, 53FK10007, 53FK08892, 53FK07949, 53FK07186,
53FK0650l, 53FL11279, 53FN02577, 53FL08351, 53FK01128,
53KR33163, 53KS30005, 53KR29664, 53KR27900, 53GN36777,
53GL29052, 53KY34757, 53KS21162, 53GJ19300, 05L05446,
05K10117, 05N68100, 05H07016, 05S43878;
(b) 53FK13077, 53K10007, 53FL08351, 05L05446, 05K10117,
05N68100, 05H07016;
(c) 53FL11279, 53KR33163, 05S43878;
(d) 53FK13077, 53FN02577, 53KS30005, 53KR29664, 53GN36777,
53GL29052, 53KY34757, 53KS21162, 53GJ19300;
(e) 53GH28576, 53GH28149, 53FK11578, 53FK10007, 53FK08892,
53FK07949, 53FK07186, 53FK06501, 53FL11279, 53FL08351,
53FK01128, 53KR33163, 05S43878;
(f) 53FK06501, 53FN02577;
(g) 05L05446, 05K10117, 05N68100, 05H07016.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
-4-RECALLED BY Manufacturer, by letters in June and July 1994. Firm-
initiated recall complete.
DISTRIBUTION Maryland, Virginia, California, North Carolina, Washington,
D.C., Switzerland.
QUANTITY (a) 27 units; (b) 7 units; (c) 3 units; (d) 9 units;
(e) 13 units; (f) 2 units; (g) 4 units.
REASON Blood products, which tested repeatedly reactive for the
antibody to the human immunodeficiency virus type 1 (anti-
HIV-1), or which tested negative for anti-HIV-1 but were
collected from a donor who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-076/077-6.
CODE Unit numbers: KC58133 and KE43756.
MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa.
RECALLED BY Manufacturer, by letter dated December 27, 1994. Firm-
initiated recall complete.
DISTRIBUTION Iowa.
QUANTITY 2 units of each component.
REASON Blood products, which were collected from a donor who had
traveled to an area designated as endemic for malaria, were
distributed.
_______________
PRODUCT Source Plasma. Recall #B-080-6.
CODE Unit #XK81410.
MANUFACTURER Community Bio-Resources, Inc., Louisville, Kentucky.
RECALLED BY Manufacturer, by letter dated June 13, 1995. Firm-initiated
recall complete.
DISTRIBUTION Austria.
QUANTITY 1 unit.
REASON Blood product, which was collected from a donor who had
sexual contact with an individual who tested positive for
the human immunodeficiency virus type 1 (HIV-1), was
distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS: CLASS III
=====================
_______________
PRODUCT Recovered Plasma. Recall #B-064-6.
CODE Unit #53GZ73217.
MANUFACTURER American Red Cross, Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated February 7, 1995. Firm-
initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, corresponding to Red Blood Cells which was
contaminated with a gram positive coccus suspected to be
Staphylococcus epidermidis, was distributed.
-5-_______________
PRODUCT Fresh Frozen Plasma. Recall #B-079-6.
CODE Unit numbers: M50204 and M50205.
MANUFACTURER Carolina Georgia Blood Center, Inc., Greenville, South
Carolina.
RECALLED BY Manufacturer, by letter dated April 21, 1995. Firm-
initiated recall complete.
DISTRIBUTION South Carolina, North Carolina.
QUANTITY 2 units.
REASON Blood product, which was prepared greater than eight hours
after phlebotomy, was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Glutaraldehyde Concentration Indicator Strips
(a) ProChek G (15 strip) foil packs;
(b) OmniChek G (15 strip) foil packs;
(c) ProChek G (3 strip) foil packs. Recall #Z-074/076-6.
CODE Lot numbers: (a) 0827995, 0828095, 1929895, 1929995,
1930295, 2030095, 2030195, 2030395;
(b) 2631395, 2631495, 2631595; (c) 1227995, 1228195,
1629095, 1629195, 1629295, 1729295, 1729395, 1729495,
1729595, 1829695.
MANUFACTURER Albert Browne, Ltd., Anstay Leicester, UK.
RECALLED BY Cottrell, Ltd., Englewood, Colorado, by verbal notification
on October 6, 1995, followed by letter October 9, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 2,652 packs; (b) 71 packs; (c) approximately 24,666
sample packs were distributed.
REASON The products have degraded as a result of incomplete package
seals introduced at the time of manufacture, causing the
strips to indicate a "Pass" condition instead of a "Fail"
condition when a glutaraldehyde solution is at or below a
minimum effective concentration of 1.5%.
_______________
PRODUCT Rubella IgM Elisa Serology Test Kit, 96 determinations, in-
vitro diagnostic for the detection of IgM antibodies to
Rubella antigen in human serum by Enzyme-Linked
Immunosorbent Assay. Recall #Z-077-6.
CODE Catalog #2305350, Lot numbers: ST15-104, ST15-105, ST15-106,
715-106M, ST15-108, ST15-109, ST15-109A.
MANUFACTURER Clark Laboratories Inc., Jamestown, New York.
RECALLED BY Manufacturer, by letter dated September 15, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 409 kits were distributed; firm estimates none remains on
the market.
REASON These lots provided false positive test results.
-6-_______________
PRODUCT Gesco brand 3 Fr. Per-Q-Cath Tray with Guidewire, a silicone
radiopaque percutaneous central venous catheter available in
a tray with accessories for vascular access.
Recall #Z-115-6.
CODE Catalog #P3G, Lot #21-060196.
MANUFACTURER Gesco International, Inc., Subsidiary of MedChem Products,
Inc., San Antonio, Texas.
RECALLED BY MedChem Products, Inc., Woburn, Massachusetts, by letters
dated June 2, 1995, and October 3, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 11,365 units were distributed from June 27 to October 13,
1994.
REASON Complaints of leakage and breakage exceeded historical
limits.
_______________
PRODUCT CT Scanners with Software Version 2.1 installed, used to
produce cross-sectional images of the body by computer
reconstruction of x-ray transmission data:
(a) Model Twin; (b) Model Helicat. Recall #Z-131/132-6.
CODE Units with software version 2.1 installed.
MANUFACTURER Elscint Ltd. Haifa, Israel.
RECALLED BY Elscint, Inc., Hackensack, New Jersey. FDA approved the
firm's corrective action plan November 9, 1995. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 18 units.
REASON An error in the software coding the scan data may be lost
during the process of archiving the data and consequently
producing no images.
-7-
END OF ENFORCEMENT REPORT NOVEMBER 22, 1995. BLANK PAGES MAY
FOLLOW.
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