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.
March 5, 1997 97-10
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT RX Guiatuss with Codeine Syrup, in 1 gallon,
16 ounce, 8 ounce, and 4 ounce bottles, an
expectorant, cough suppressant, under the
following labels: Barre, Rugby, Schein, and
H.L. Moore.
Recall #D-120-7.
CODE Lot numbers: RB6059, RA6016, RS5841, RP5742,
RP5743, RN5652, RL5568, RK5512, RJ5429,
RB5089, RA5028, RA5027.
MANUFACTURER Alpharma (Barre-National), Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter on January 14, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,563,288 units were distributed.
REASON Product lacks stability (i.e. codeine
phosphate analysis results showed decreasing
potency).
_______________
PRODUCT Sodium Acetate Injection, USP, 100 mEq, (2
mEq/ml), Preservative Free, in 50 ml single
dose vials, for IV use only after dilution, as
a source of sodium for addition to large
volume IV fluids to prevent or correct
hyponatremia in patients with restricted or no
oral intake. Recall #D-121-7.
CODE Lot numbers: 150681 EXP 5/97, 160634 EXP
4/98.
MANUFACTURER Fujisawa USA, Inc., Melrose Park, Illinois.
RECALLED BY Fujisawa USA, Inc., Deerfield, Illinois, by
letter dated February 11, 1997. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 29,375 vials were distributed; firm estimated
that 25 percent of the product remained on
market at time of recall initiation.
REASON Label error on declared strength (i.e. label
incorrectly states "Each ml contains 272.16 mg
sodium acetate" (anhydrous), it should read,
"Each ml contains 164 mg sodium acetate
(anhydrous).
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-386/387-7.
CODE Unit #40GT45514.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on July 23, 1996,
followed by letter dated July 30, 1996. Firm-
initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1).
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-388/389-7.
CODE Unit #40GL09293.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on July 23, 1996,
followed by letter dated July 30, 1996. Firm-
initiated recall complete.
DISTRIBUTION Florida and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1).
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-390/391-7.
CODE Unit #40GT45575.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on July 23, 1996,
followed by letter dated July 30, 1996. Firm-
initiated recall complete.
DISTRIBUTION Illinois and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1).
_______________
PRODUCT Red Blood Cells. Recall #B-416-7.
CODE Unit numbers: S54405, S56115, S56761, S49163,
S55063.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY Manufacturer, by telephone on January 5, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 5 units were distributed.
REASON Blood products were stored at an unacceptable
temperature.
_______________
PRODUCT Red Blood Cells. Recall #B-409-7.
CODE Unit numbers: 4004474, 1681268, 3010521,
3500779, 6007126, 7414729, 8007064, 4008128,
2000304, 1031016, 5023984, 7153469, 5009721,
4007348.
MANUFACTURER LifeSource Blood Services, Glenview, Illinois.
RECALLED BY Manufacturer, by letter dated April 18, 1996.
Firm-initiated recall complete.
DISTRIBUTION California, Illinois, Kentucky, Ohio.
QUANTITY 14 units were distributed.
REASON Blood products were not tested for anti-HCV
and no further testing was conducted on the
donors.
_______________
PRODUCT Red Blood Cells. Recall #B-417-7.
CODE Unit #47T29763.
MANUFACTURER American Red Cross Blood Services, Galesburg,
Illinois.
RECALLED BY American Red Cross Blood Services, Peoria,
Illinois, by telephone on August 30, 1996,
followed by letter. Firm-initiated recall
complete.
DISTRIBUTION Iowa.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for
the antibody to the hepatitis B core antigen
(anti-HBc).
_______________
PRODUCT Platelets. Recall #B-418-7.
CODE Unit #53F10114.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated October 28,
1996. Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Blood product was positive for anti-Kell and
anti-Jsa antibodies was distributed and
labeled as negative for unexpected antibodies.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma. Recall #B-423/425-7.
CODE Unit #29045-5068.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by letter dated September 9,
1996. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested initially reactive for
the hepatitis B surface antigen (HBsAg), but
had no repeat testing performed.
_______________
PRODUCT Platelets. Recall #B-427-7.
CODE Unit #53T32131.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated January 11,
1996. Firm-initiated recall complete.
DISTRIBUTION District of Columbia.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
whole blood with an extended collection time.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-428/429-7.
CODE Unit #53GN66133.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated October 10,
1995. Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who
emigrated from a malarial endemic area within
three years of donation.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-376/377-7.
CODE Unit numbers: 2649385 and 4900157.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone on September 5-6,
1996, and by letter dated September 27, 1996.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 2 units of each component were distributed.
REASON Blood products not quarantined and released
despite the donor's use of confidential
exclusion sticker.
_______________
PRODUCT Recovered Plasma. Recall #B-382-7.
CODE Unit #24124.
MANUFACTURER Marshalltown Medical & Surgical Center,
Marshalltown, Iowa.
RECALLED BY Manufacturer, by telephone, fax, and by letter
on November 10, 1994. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product was distributed prior to
completion of testing and subsequently tested
repeat reactive for anti-HBc.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-415-7.
CODE Unit numbers: 360052 364583 364818 365018
365066 365085 366376 366997 367010 367013
367016 367018 367767 368261 368573 368584
368590 368593 368598 368617 369730 369740
369749 369754 370993 371013 371273 371979
371982 371987 371995 372001 372011 372012
372014 372020 372021 372024 372025 372028
372238 372243 372246 373232 373716 380463
380488 380491 380493 380496 380498.
MANUFACTURER Memorial Blood Centers of Minnesota,
Minneapolis, Minnesota.
RECALLED BY Manufacturer, by telephone on February 13,
1996. Firm-initiated recall complete.
DISTRIBUTION Minnesota.
QUANTITY 51 units were distributed.
REASON Blood products were stored at temperatures
exceeding acceptable limits.
_______________
PRODUCT Red Blood Cells. Recall #B-419-7.
CODE Unit numbers: 17179-9840 and 17179-9966.
MANUFACTURER United Blood Services, McAllen, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on October 7, 1996. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 2 units were distributed.
REASON Blood products may have been exposed to
unacceptable temperatures.
_______________
PRODUCT Red Blood Cells. Recall #B-420-7.
CODE Unit numbers: 17179-8777, 17179-9747, 17180-
1248, 17180-1210, 17180-1048, 17180-0470.
MANUFACTURER United Blood Services, McAllen, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on September 23, 1996. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 6 units were distributed.
REASON Blood products may have been exposed to
unacceptable temperatures.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-430/431-7.
CODE (a) 0310131, 0310103, 0310147, 0310143; (b)
0310094, 0310098, 0310141.
MANUFACTURER Community Blood Bank of Lancaster County
Medical Society, Lincoln, Nebraska.
RECALLED BY Manufacturer, by telephone on May 15, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nebraska.
QUANTITY (a) 4 units; (b) 3 units were distributed.
REASON Blood products were incorrectly tested for the
hepatitis B surface antigen (HBsAg).
_______________
PRODUCT Whole Blood. Recall #B-453-7.
CODE Unit #53GJ31002.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by telephone on October 23,
1995. Firm-initiated recall complete.
DISTRIBUTION District of Columbia.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.
RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II =========
_______________
PRODUCT Adult Arterial Filters, indicated for use in
cardiopulmonary bypass procedures for removal
of particulate and gaseous micro emboli:
(a) Model No. 20; (b) Model No. M-220;
(c) Model No. M-40; (d) Model No. M-440;
(e) Model No. CBM-20; (f) Model No. CBM-40.
Recall #Z-287/292-7.
CODE Lot Numbers: 0132407-1 and 032406-501.
MANUFACTURER Medtronic Cardiopulmonary, Anaheim,
California.
RECALLED BY Manufacturer, by letter dated October 25,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 90,000 units were distributed.
REASON Breakage at the arterial outlet port.
_______________
PRODUCT Z-274/281-7, Royal Flush Plug Angiographic
Catheters with Beacon Enhanced Radiopaque
Tips, which appeared in the February 26, 1997,
Enforcement Report should read:
MANUFACTURER: Cook, Inc., Bloomington,
Indiana.
END OF ENFORCEMENT REPORT FOR MARCH 5, 1997. BLANK PAGES MAY FOLLOW.
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End of Enforcement Report for
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