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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