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
05/26/1993

Recalls and Field Corrections: Foods -- Class II -- 05/26/1993

MAY 26, 1993 93-21

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________
PRODUCT Sure-Curd, a coagulant enzyme used in cheese manufacturing,
in 5 gallon containers. Recall #F-343-3.
CODE M33220-F0605-05Y.
MANUFACTURING Pfizer Inc., Food Science Group, Milwaukee, Wisconsin.
RECALLED BY Manufacturer, by letter April 15, 1993. Firm-initiated
recall complete.
DISTRIBUTION Illinois, New York, Ohio, Utah, Wisconsin.
QUANTITY 228 5-gallon containers were distributed.
REASON The product was manufactured using city water that may have
been contaminated with cryptosporidium.

_______________
PRODUCT Artificially flavored Strawberry Magic Fizz Popping Candy.
Recall #F-344-3.
CODE Uncoded.
MANUFACTURER Coca-Cola Foods, a division of the Coca-Cola Company,
Houston, Texas.
RECALLED BY Manufacturer, by Fax April 7, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,300,000 packages were distributed.
REASON Product is contaminated with metal fragments.

_______________
PRODUCT Orchid brand Mandarin Orange Segments in light syrup, in 11
ounce cans. Recall #F-345-3.
CODE Manufacturing dates of 1988, 1989, and 1991.
MANUFACTURER Nanchang Cannery and Brewery, Peoples Republic of China
(manufacturer of the cans manufactured in 1991). The
manufacturer of the 1988 and 1989 product is unknown.
RECALLED BY CTC Food International, Inc., doing business as Oriental
Trading Company International Inc., South San Francisco,
California, by letter between March 10 and 12, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Washington state, California, Oregon, Hawaii.
QUANTITY 3,998 cases (24 cans per case) with manufacturing dates of
1991, were distributed. Quantity for the product with
manufacturing dates of 1988 and 1989, is undetermined.
REASON Product contains excessive levels of lead.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________
UPDATE Diazepam Injection, UPS 5 mg/ml, and Cyanocobalamin
Injection, 1000 mcg/ml, Recall #D-208/209-3, manufactured
by Steris Laboratories, which appeared in the April 14,
1993 Enforcement Report involves products distributed under
the H.L. Moore label only.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________
PRODUCT Bulk Guaifenensin USP, in 50 or 50.6 kg fiber drums.
Recall #D-268-3.
CODE Lot numbers range between 22766 and 30921.
MANUFACTURER B.I. Chemical Corporation, Petersburg, Virginia.
RECALLED BY Manufacturer, by letter April 16 and 26, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Midwest and east coast.
QUANTITY 157,063 kg were distributed.
REASON Presence of aluminum particles.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________
PRODUCT Recovered Plasma. Recall #B-239-3.
CODE Unit numbers: 0348530, 0348540, 0349880, 0349950, 0350050.
MANUFACTURER Our Lady of Lourdes Regional Medical Blood Center,
Lafayette, Louisiana.
RECALLED BY Manufacturer, by telephone December 4, 1992. Firm-
initiated recall complete.

-2-DISTRIBUTION Florida.
QUANTITY 5 units.
REASON Blood products which tested initially reactive for the
hepatitis B surface antigen (HBsAg) were distributed.

_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Platelets; (d)
Cryoprecipitated AHF; (e) Platelets for Further
Manufacture; (f) Recovered Plasma. Recall #B-240/245-3.
CODE Unit numbers: (a) 01K24554, 01K39576; (b) 01G08587,
01GG02332, 01K44030, 01K47450, 01M43643, 01M46659,
01X14111; (c) 01K47450, 01M46659, 01X14111; (d) 01GG02332,
01K44030; (e) 01M43643; (f) 01G08587, 01GG02332, 01K44030,
01K47450, 01M43643, 01M46659, 01X14111.
MANUFACTURER American Red Cross Blood Services, Rochester, New York.
RECALLED BY Manufacturer, by telephone between October 12, 1991, and
October 6, 1992, and by letters dated between October 31,
1991, and December 2, 1992. Firm-initiated recall ongoing.
DISTRIBUTION New York, Tennessee, California, Switzerland.
QUANTITY (a) 2 units; (b) 7 units; (c) 3 units; (d) 2 units; (e) 1
unit; (f) 7 units.
REASON Blood products, which tested negative for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1), but
were collected from donors who previously tested repeatedly
reactive for anti-HIV-1, were distributed.

_______________
PRODUCT Source Plasma. Recall #B-255-3.
CODE N-24691-142.
MANUFACTURER M.P.S., Inc., doing business as Opelousas Plasma Center,
Opelousas, Louisiana.
RECALLED BY Manufacturer, by telephone and by facsimile February 10,
1993. Firm-initiated recall complete.
DISTRIBUTION California and Germany.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly reactive for the
antibody to the hepatitis C virus (anti-HCV), was
distributed.

_______________
PRODUCT Platelets, Pheresis. Recall #B-256-3.
CODE Unit numbers: 461899, 461900, 466301, 466302, 466303,
466305.
MANUFACTURER Community Blood Center, Dayton, Ohio.
RECALLED BY One consignee notified firm and firm notified other
consignees by telephone on January 15, 1993. Firm-
initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 6 units.
REASON Blood products labeled with the incorrect expiration dates
were distributed.

-3-_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen
Plasma; (d) Platelets for Further Manufacture; (e)
Recovered Plasma. Recall #B-259/263-3.
CODE Unit numbers: (a) 01GG01581, 01GG04913, 01H39340,
01H71925, 01K46095, 01K71331, 01X43584;
(b) 01GG01581, 01GG04913, 01H71925, 01K71331, 01X43584; (c)
01H71925, 01K46095, 01X43584; (d) 01K46095; (e) 01GG01581,
01K71331.
MANUFACTURER American Red Cross Blood Services, Rochester, New York.
RECALLED BY Manufacturer, by telephone July 30, 1992, and May 10, 1992,
and by letters dated March 10, April 29, May 1, June 18,
July 29, August 27, September 16, and October 15, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION New York, California.
QUANTITY (a) 7 units; (b) 5 units; (c) 3 units; (d) 1 unit; (e) 2
units.
REASON Blood products, collected from donors who either reported
histories of behavior which are known to increase risk of
developing Acquired Immune Deficiency Syndrome (AIDS);
reported a history of hepatitis; or previously tested
repeatedly reactive for the antibody to hepatitis C virus
encoded antigen (anti-HCV), were distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen
Plasma; (d) Platelets for Further Manufacture;
(e) Recovered Plasma. Recall #B-246/250-3.
CODE Unit numbers: (a) 01G56528, 01G84914, 01H64537, 01K49746,
01K58979, 01X08779, 01X17079, 01X41416, 01X66673; (b)
01G84914, 01H64537, 01K58979, 01X17079, 01X41416; (c)
01H64537; (d) 01X08779; (e) 01G56528, 01G64022, 01G84914,
01K49746, 01K58979, 01X08779, 01X17079, 01X41416.
MANUFACTURER American Red Cross Blood Services, Rochester, New York.
RECALLED BY Manufacturer, by telephone between October 12, 1991, and
October 6, 1992, and by letters dated between October 31,
1991, and December 2, 1992. Firm-initiated recall ongoing.
DISTRIBUTION New York, Tennessee, California, Switzerland.
QUANTITY (a) 9 units; (b) 5 units; (c) 1 unit; (d) 1 unit; (e) 8
units.
REASON Blood products, which tested negative for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1), but
were collected from donors who previously tested repeatedly
reactive for anti-HIV-1, were distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-251-3.
CODE Unit #G41311.
MANUFACTURER Sacramento Medical Foundation Blood Center, Sacramento,
California.
-4-RECALLED BY Manufacturer, by telephone January 7, 1992. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.

_______________
REASON Blood product, collected from a donor who tested initially
reactive for the antibody to human immunodeficiency virus
type 1 (anti-HIV-1), was distributed.
PRODUCT Whole Blood. Recall #B-252-3.
CODE Unit #X12286.
MANUFACTURER Holmes Regional Medical Center, Inc., Melbourne, Florida.
RECALLED BY Consignee notified firm, by telephone January 11, 1993.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit.
REASON Blood product, labeled with the incorrect expiration date,
was distributed.

_______________
PRODUCT Whole Blood. Recall #B-253-3.
CODE Unit #9224736.
MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida.
RECALLED BY Consignee notified firm by telephone February 11, 1993.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit.
REASON Blood product labeled with the incorrect expiration date
was distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-254-3.
CODE Unit #5605197.
MANUFACTURER Department of the Navy, Naval Hospital Blood Bank,
Pensacola, Florida.
RECALLED BY Consignee notified firm by telephone August 22, 1992.
Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit.
REASON Blood product labeled with the incorrect expiration date
was distributed.

_______________
PRODUCT (a) Red Blood Cells Frozen; (b) Recovered Plasma.
Recall #B-257/258-3.
CODE Unit #4780199.
MANUFACTURER Department of the Navy, National Naval Medical Center,
Bethesda, Maryland.
RECALLED BY Manufacturer, by telephone September 24, 1992. Firm-
initiated recall complete.

-5-DISTRIBUTION New Jersey.
QUANTITY 1 unit of each component.
REASON Blood products, which tested negative for the 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, were distributed.

RECALLS AND FIELD CORRECTION: DEVICES -- CLASS II
_______________
PRODUCT Embolic Coil Pusher-16 used to facilitate the delivery of
embolic coils through a catheter to an area of vascular
abnormality. Recall #Z-530-3.
CODE Product #401216, lot numbers: A13770, A13783, A13807,
A13820, A13839, A13886, A13904.
MANUFACTURER Target Therapeutics, Inc., Fremont, California.
RECALLED BY Manufacturer, by telephone, fax, or by visit in February
1993, followed by letter February 22, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 395 units were distributed; firm estimates 20 percent of
the product remains on the market.
REASON The Teflon Sheath wall thickness may be less than the
firm's specification which results in less strength while
advancing the coil, and promotes the likelihood of the
Teflon sheath to buckle, kink or perforate.

_______________
PRODUCT 5mm Grasping Forceps with Ratchet, Model B-2, used for
removing and manipulating damaged tissue after a small
incision during surgery. Recall #Z-531-3.
CODE All codes.
MANUFACTURER Jakoubek, Germany.
RECALLED BY Endolap, Inc., Orlando, Florida, by telephone December 14,
1992, followed by letter. Firm-initiated recall ongoing.
DISTRIBUTION California, Arizona, Florida, Oklahoma, North Carolina,
Illinois, Iowa, Pennsylvania, Kansas, New Jersey.
QUANTITY 36 units were distributed.
REASON The instrument may fail, e.g., the ratchet (spring) may
break, and the device will not open or close.

_______________
PRODUCT Site TXR Disposable Peristaltic Cassette, used in eye
surgery. Recall #Z-542-3.
CODE Order part #600-2100, lot #PQ088.
MANUFACTURER Iolab, Puerto Rico.
RECALLED BY Iolab Corporation, Claremont, California, by telephone and
written notification. Recalls were destroyed July 20,
1992. Firm-initiated recall complete.
DISTRIBUTION Arizona, California, Florida, Indiana, Maryland, Nevada,
Oklahoma, Pennsylvania, Texas, Virginia, West Virginia.
QUANTITY 1,188 units were distributed.

-6-REASON Non-sterile units for testing (packaged and labeled as
finished, sterile product) were erroneously distributed.

_______________
PRODUCT Storz Coburn Intraocular Lens, Model P337LUV, + 23.0
Diopter, Haptic Angle 6.5 Degrees. Recall #Z-543-3.
CODE Control numbers beginning with 8H72.
MANUFACTURER Storz Ophthalmics, Inc., Clearwater, Florida.
RECALLED BY Storz Instrument Company, St. Louis, Missouri, by telephone
February 25, 1993, followed by letter March 12, 1993.
Firm-initiated recall complete.
DISTRIBUTION Minnesota.
QUANTITY 11 lenses were distributed; firm estimates none remains on
the market.
REASON The lenses were packaged upside down in the containers
causing the vaulting to be reversed.

_______________
PRODUCT Microlight 830 Cold Laser Therapy System, consisting of
Microlight 830 Laser Probe, Battery/Charging Console, and
Battery Pack, used for the treatment of carpal tunnel
syndrome. Recall #Z-544-3.
CODE Serial numbers: 105, 107, 108, 120, 121, 123, 124, 125,
126, 127, 142, 145, 147, 149, 150, 151, 156, 158, 163, 167,
168, 171, 174, 1052, 1053, 1141, and 14 units without
serial numbers. Note that prior to december 19, 1991, the
devices were not labeled with serial numbers.
MANUFACTURER CB Svendsen a/s, Vaerlose, Denmark.
RECALLED BY Lasermedics, Inc., Stafford, Texas, by letter April 13,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, California, Florida, Kentucky, Michigan, New
Jersey, New Mexico, Nevada, New York, Oklahoma,
Pennsylvania, Texas.
QUANTITY 41 units were distributed.
REASON Devices were distributed without 510(k) approval.

_______________
PRODUCT U.S. Laser Model 303-50 Pulsed ND:YAG Laser System.
Recall #Z-548-3.
CODE None.
MANUFACTURER U.S. Laser Corporation, Wyckoff, New Jersey.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan March 5, 1993. Firm-initiated field correction
ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Noncompliance with the performance standards for laser
products. The laser system was noncompliant with the
protective housing requirements for the intro-cavity beam
path and for additional protective housing labels that are
applicable to the required protective housing.

-7-SEIZURE:
_______________
PRODUCT Chick peas (93-637-395).
CHARGES Adulterated - The article contains insects, insect
fragments, larvae, and rodent hair, and is insect damaged;
and, the it has been held under insanitary conditions
whereby it may have become contaminated with filth.
FIRM Almacenes Del Castillo, Inc., Catano, Puerto Rico.
FILED April 13, 1993; U.S. District Court for the District of
Puerto Rico; Civil #93-1576-GG; FDC #66686.
SEIZED May 3, 1993 - goods valued at approximately $34,400.

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END OF ENFORCEMENT REPORT FOR MAY 26, 1993. BLANK PAGES MAY FOLLOW.
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