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
10/14/1992
RECALLS AND FIELD CORRECTIONS: October 14, 1992
FOODS -- CLASS I
92-42
UPDATE Frozen Crabmeat, in 8 ounce tubs, manufactured by Young
Shellfish Company, Recall #F-486-2 which appeared in the August
19, 1992, Enforcement Report has been extended to include code
C-53.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT Candy gum products:
(a) Mini Fruity Toot Mix Fruit Bubble Gum Treats, 17 pieces per
package;
(b) Lem'n Lime Lemon and Lime Bubble Gum Treats, 5 pieces per
package;
(c) Gum Slingers Bullet Bubble Gum Treats, 11 pieces per
package;
(d) Bubbloids Round Bubble Gum Treats, 8 pieces per package;
(e) Fruity Toots. Recall #F-084/088-3.
CODE All lots.
MANUFACTURER Candygum S.p.A., Milano, Italy.
RECALLED BY LTX of America, McClean, Virginia, by letter July 21, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 872 cases were distributed.
REASON Products contain undeclared FD&C Yellow No. 5.
PRODUCT Maybelline 175M-01 Great Lash Mascara Very Black, in 0.43 fluid
ounce blister pack bottle. Recall #F-089-3.
CODE Lot #2H109.
MANUFACTURER Maybelline Products Company, Inc., North Little Rock, Arkansas.
RECALLED BY Manufacturer, by letter August 21, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 20,706 units were distributed.
REASON Product contains metal particles.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLALSS II
PRODUCT Dicyclomine HCl Tablets, USP, 20 mg, in bottles of 100, 500,
and 1,000, a Rx anti-spasmodic and anti-cholinergic.
Recall #D-011-3.
CODE Lots numbered consecutively 6013-30 through 6013-123.
MANUFACTURER Pioneer Pharmaceuticals, Inc., Irvington, New Jersey.
RECALLED BY Manufacturer, by fax April 9, 1992, and by letter April 13,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 26,846,500 tablets were distributed.
REASON Use of unapproved manufacturing procedures.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Rx oral solutions:
(a) Thioridazine Hydrochloride Oral Solution, USP, 30 mg/ml
(Concentrate); 4 fluid ounce amber glass bottles, used for the
management of manifestations of psychotic disorders,
distributed under PBI, Major, GG labels;
(b) Thioridazine Hydrochloride Oral Solution, USP, 100 mg/ml
(Concentrate), in 4 fluid ounce amber glass bottles, used for
the management of manifestations of psychotic disorders,
distributed under PBI, Major labels;
(c) Trifluoperazine Hydrochloride Oral Solution (Concentrate)
10 mg/ml, 2 fluid ounce amber glass bottles, used for the
management of the manifestations of psychotic disorders,
distributed under PBI, W/C Warner Chilcott, UDL labels.
Recall #D-012/014-3.
CODE All lots.
MANUFACTURER Pharmaceutical Basics, Inc., Morton Grove, Illinois.
DISTRIBUTION Nationwide.
QUANTITY The firm estimates that (a) 6,800 bottles; (b) 7,400 bottles;
(c) 5,300 bottles remain on the market.
REASON Products fail stability specifications for color prior to
expiration date.
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RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT Platelets. Recall #B-441-2.
CODE Unit #90028.
MANUFACTURER Memorial Blood Center of Minneapolis, Minneapolis, Minnesota.
RECALLED BY Manufacturer, by telephone June 1, 1992. Firm-initiated recall
complete.
DISTRIBUTION Minnesota.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly reactive for the
antibody to hepatitis B core antigen (anti-HBC), was
distributed for transfusion.
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-003/004-3.
CODE Unit #49F10415.
MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by letter dated November 7, 1991. Firm-initiated
recall ongoing.
DISTRIBUTION Oklahoma, California.
QUANTITY 1 unit of each component.
REASON Blood products, which tested negative for hepatitis B surface
antigen (HBsAg) but were collected from a donor who previously
tested repeatedly reactive for HBsAg, were distributed.
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-005/007-3.
CODE Unit #5Z5147.
MANUFACTURER Puget Sound Blood Center, Seattle, Washington.
RECALLED BY Manufacturer, by telephone and by letters dated October 28,
1991, and November 20, 1991. Firm-initiated recall ongoing.
DISTRIBUTION Washington state, New York.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor who reported an exposure
to hepatitis seven months prior to donation, were distributed.
PRODUCT Antilymphoblast Globulin (Equine). Recall #B-010-3.
CODE Lot #50280E.
MANUFACTURER University of Minnesota, Department of Surgery, Minnesota ALG
Program, St. Paul, Minnesota.
RECALLED BY Manufacturer, by telephone July 30 and 31, 1992, followed by
letters sent on or about August 4, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY Approximately 1,070 vials were distributed.
REASON Vials of ALG which had leaky seals were distributed.
PRODUCT Fresh Frozen Plasma. Recall #B-011-3.
CODE Unit #P07079.
MANUFACTURER Marathon County Blood Bank, Wausau, Wisconsin.
-3-
RECALLED BY Manufacturer, by telephone on or about April 9, 1992, followed
by letter April 21, 1992. Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit.
REASON Blood product which tested repeatedly reactive for the
antibodies to the human immunodeficiency virus, type 1 and 2
(anti-HIV-1/2) was distributed for transfusion.
PRODUCT Platelets. Recall #B-012-3.
CODE Unit numbers: 1818328, 1818331, 1820675.
MANUFACTURER The Greater New York Blood Program, doing business as Hudson
Valley Blood Services, Valhalla, New York.
RECALLED BY Manufacturer, by telephone May 30, 1991. Firm-initiated recall
complete.
DISTRIBUTION New York.
QUANTITY 3 units.
REASON Platelets labeled with incorrect expiration dates were
distributed.
PRODUCT Recovered Plasma. Recall #B-013-3.
CODE Unit #05S69396.
MANUFACTURER American Red Cross Blood Services Washington Research Project
(former Washington Region), Washington, D.C.
RECALLED BY Manufacturer, by letters dated January 8, 1992, and February 5,
1992. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly reactive for the
antibody to human immunodeficiency virus type 1 (anti-HIV-1),
was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-008/009-3.
CODE Unit #112160.
MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, Alaska.
RECALLED BY Manufacturer, by telephone August 28, 1992. Firm-initiated
recall complete.
DISTRIBUTION Alaska.
QUANTITY 1 unit of each component.
REASON Blood products, untested for the antibodies to human
immunodeficiency virus, types 1 and 2 (anti-HIV-1/2, were
distributed.
PRODUCT Recovered Plasma. Recall #B-014-3.
CODE Unit #05M31502.
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MANUFACTURER American Red Cross Blood Services Washington Research Project
(former Washington Region), Washington, D.C.
RECALLED BY Manufacturer, by letters dated January 8, 1992, and February 5,
1992. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly reactive for the
antibody to human immunodeficiency virus type 1 (anti-HIV-1),
was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Guardian Transfer Benches, used to support an individual in a
sitting position while they move from one location to another:
(a) Model #98008 Transfer Bench, Non-Padded;
(b) Model #98009 Transfer Bench, Non-padded, with commode
opening;
(c) Model 98013 Transfer Bench, Padded, with commode opening;
(d) Model 98014 Transfer Bench, Padded;
(e) Model 98314 Economy Transfer Bench, padded.
Recall #Z-1322/1326-2.
CODE All units with the date codes 920201 through 920318.
MANUFACTURER Guardian Products, Inc., North Hollywood, California.
RECALLED BY Manufacturer, by letter March 23, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 151 units; (b) 42 units; (c) 268 units; (d) 467 units;
(e) 509 units were distributed.
REASON The backrest component may not attach securely to the frame
underside members and fall off, due to improperly crimped
nut-certs (riv nuts) in the frame attachment holes.
UPDATE Recall #Z-1224/1235-2, which appeared in the September 2, 1992
Enforcement Report should include:
Steerocath Standard Distal 1/Bidirectional Steerable Pacing
Catheter, Custom Model, lot numbers 1L061, 1L002, 1L066.
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II
PRODUCT (a) Sunup Sulfamethazine Prolonged Release Bolus;
(b) Sulfa-Span Sulfamethazine Anti-Bacterial Prolonged Release
Bolus. Recall #V-001/002-3.
CODE Lot numbers: (a) 112623, 112624; (b) 112567 through 112578.
MANUFACTURER Miles, Inc., Shawnee Mission, Kansas.
RECALLED BY Manufacturer, by letter September 3 and 9, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
-5-
QUANTITY (a) 1,643 50-pound bolus packages; (b) 9,806 50-pound bolus
packages were distributed.
REASON Unapproved source of bulk sulfamethazine used in the
manufacture of the products.
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END OF ENFORCEMENT REPORT FOR OCTOBER 14, 1992. BLANK PAGES MAY
FOLLOW.
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