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
08/16/1995
ENFORCEMENT REPORT FOR 08/16/95
August 16, 1995 95-33
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Various types of chocolate candies in 6 pound and 12 pound
containers; (1) Blueberry cream - dark; (2) Blueberry
cream -light; (3) Chocolate cream - dark; (4) Chocolate
cream milk; (5) Coconut cream - dark; (6) Coconut cream -
milk; (7) Coffee cream - dark; (8) Coffee cream - milk; (9)
Fudge - chocolate; (10) Fudge vanilla; (11) Maple cream -
dark; (12) Maple cream - milk; (13) Marshmallow - dark; (14)
Marshmallow - milk; (15) Nougats - dark; (16) Nougats -
milk; (17) Orange cream - dark; (18) Orange cream - milk;
(19) Peppermint patties - dark; (20) Peppermint patties -
milk; (21) Raspberry cream - dark (22) Raspberry cream -
milk; (23) Strawberry cream - dark; (24) Strawberry cream -
milk; (25) Vanilla cream - dark; (26) Vanilla cream - milk;
(27) Rocky road* - dark; (28) Rocky road* - milk;
(29) Fudge - peanut butter*; (30) Butter cream - dark; (31)
Butter cream - milk; (32) Lemon cream - dark; (33) Lemon
cream - milk; (34) Declairs - milk**; (35) Fudge - chocolate
nut***; (36) Fudge - vanilla nut***; (37) Figaros - milk
chocolate ****; (38) Figaros - dark chocolate****, Recall
#F-720/757-5.
CODE Not coded.
MANUFACTURER Philadephia Candies, Inc., Sharon, Pennsylvania.
RECALLED BY Manufacturer by letter June 1, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Pennsylvania, Ohio, New Hampshire, Georgia, Michigan, New
York, Vermont.
QUANTITY Unknown.
REASON All the products except Figaros contain eggs and eggs are
not declared on the label. In addition the products marked
* - contain undeclared peanuts, ** - contain undeclared
pecans, *** - contain undeclared walnuts, and **** - contain
undeclared filbert (hazelnut) paste only.
_______________
PRODUCT Rose shaped candy cake decorations, packaged 6 per pack/1
dozen per box and 6 dozen boxes per carton, Recall #F-763-5.
CODE All product manufactured since May 1994 to present.
MANUFACTURER Decko Products, Inc., Sandusky, Ohio
RECALLED BY McCormick and Company, Inc., Hunt Valley, Maryland by
press release via letter dated July 26, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico.
QUANTITY 16,612.75 dozen boxes were distributed.
REASON The product contains eggs and eggs are not listed as an
ingredient.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT "California Mix" (trail mix consisting of various dried
fruits and nuts, packaged in 10 pound, or 25 pound cardboard
boxes, Recall #F-759-5.
CODE All product with expiration date prior to "January 1996".
MANUFACTURER New England Natural Bakers, Inc., South Deerfield,
Massachusetts.
RECALLED BY Manufacturer by visit June 27, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Massachusetts, New York, Vermont.
QUANTITY Firm estimates none remain on market.
REASON The product contains undeclared sulfits.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Walgreen's Distilled Water, sodium free in one gallon
plastic jugs, Recall #F-758-5.
CODE All lots with UPC #0 49022-06588 8.
MANUFACTURER Mineral Springs Water, Mineral Springs, Arizona.
RECALLED BY Walgreen Company, Deerfield, Illinois by electronic mail
July 20, 1995. Firm-initiated recall ongoing
DISTRIBUTION Louisiana, Tennessee, Kansas, Texas.
QUANTITY 37,260 gallons were distributed.
REASON The label is false and misleading since the solid content
shows it is not distilled water.
_______________
PRODUCT (a) Lady Lee brand 100% Pasteurized Orange Juice, (b) Bel
Air brand Homestyle with Juicy Orange Bits Premium Squeezed
Pasteurized Orange Juice Not From Concentrate, Recall #F-
760/761-5.
CODE "07-17-95" Pull Date.
MANUFACTURER Olympic Foods, Inc., Spokane, Washington.
RECALLED BY Manufacturer by facsimiles on June 12 and 13, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Washington state, California.
QUANTITY (a) 725 cases; (b) 1,082 cases were distributed.
REASON The product is unfit for food due to contamination with
lactobacillus.
_______________
PRODUCT Vita-Min 75 Extra High Potency Multiple Vitamins with
chelated minerals, product labeled as a dietary supplement,
Recall #F-762-5.
CODE Lot #104-1241.
MANUFACTURER Kabco Inc., Amityville, New York.
RECALLED BY Manufacturer by letter July 31, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION New Jersey.
QUANTITY 100,000 tablets were distributed.
REASON This product is adulterated in that a valuable ingredient,
Vitamin A, has been omitted in whole or in part. The
product is also misbranded - false and misleading - label,
however, the most significant violation is the adulteration.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
=======================
_______________
PRODUCT Dilantin brand Phenytoin Sodium Injection 100 mg in 2 ml,
Recall #D-232-5.
CODE Lot #00515, exp. date 11/96.
MANUFACTURER Warner-Lambert Company, Rochester, New York.
RECALLED BY The Parke-Davis Division of Warner-Lambert Company, Morris
Plains, New Jersey, by letter July 14, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 15,157 packages were distributed.
REASON Product discoloration resulting from use of incorrect
stopper.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Red Blood Cells, Recall #B-496-5.
CODE Unit #20FF45584.
MANUFACTURER American National Red Cross, Boise, Idaho.
RECALLED BY Manufacturer, by letter January 10, 1995. Firm initiated
recall complete.
DISTRIBUTION Idaho.
QUANITY 1 unit.
REASON Blood product, which was collected from a donor who had
resided in an area designated as endemic for malaria, was
distributed.
_______________
PRODUCT Platelets, Pheresis, Recall #B-511-5.
CODE Unit #09P36514B.
MANUFACTURER American Red Cross Blood Services, Midwest Regional Blood
Service, Omaha, Nebraska.
RECALLED BY Manufacturer, on August 29, 1994. Firm-initiated recall
complete.
DISTRIBUTION Nebraska.
QUANTITY 1 unit.
REASON Blood product, corresponding to a portion of Platelets,
Pheresis, contaminated with Lancefield Group G streptococcus
and implicated in a transfusion reaction, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma, Recall #B-
512/513-5.
CODE Unit #s (a & b) 40GR42221.
MANUFACTURER American Red Cross Blood Service, Peoria, Illinois.
RECALLED BY Manufacturer by letter March 15, 1995. Firm-initiated
recall complete.
DISTRIBUTION California, New York, Illinois.
QUANTITY 2 units were distributed.
REASON Blood products, which were incorrectly tested for hepatitis
B surface antigen (HBsAg), were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Red Blood Cells Frozen; (c)
Platelets; (d) Platelets, Pheresis; (e) Fresh Frozen Plasma;
(f) Cryoprecipitated AHF; (g) Recovered Plasma; (h)
Platelets, For Further Manufacture; (i) Platelets, Pheresis
For Further Manufacture, Recall #B-518/525-5.
CODE Unit #s: (a) C05869, C26334, C26964, C27996, C29417, C29603,
C31028, C31382, C31805, C32957, C33687, C33915, C37321,
C37975, C38167, F03996, F13162, F67762, F68012, F71953,
F74399, F75873, F78014, F81015, F86804, F92762, M65401,
M76575, M92688, M95941, V07387, V53612, V54294, V55963,
V56322, V61791, V64308, W02153, W07857, X22324, X22899,
X23012, X26274, X59714; (b) M95941; (c) C05869, C27996,
C31028, C31805, C33687, C33915, C37321, C37975, C38167,
F13162, F67762, F68012, F74399, F92762, M59682, M76575,
M76887, X22324, X22899, X59714; (d) P04384-A, P04537-A,
P04537-B, P04812-A, P04812-B, P12150, P12317, P12480,
P12567, P12663, P13445, P14219, P14317, P14504, P14576,
P14656, P14844, P14938; (e) C29417, C37321, C37975, F13162,
F86804, M95941, X59714; (f) C32957; (g) F03996, F67762,
F68012, F71953, F78014, F81015, F92762, W02153, W07857; (h)
F67762, F68012, F71953, F78014, F81015, F92762, W02153,
W07857; (i) F03996, F86804, W07857; (j) P14730.
MANUFACTURER Central California Blood Center, Presno, California
RECALLED BY Manufacturer by letters between December 1993 and March
1994. Firm-initiated recall ongoing.
DISTRIBUTION California
QUANTITY 6 units were distributed.
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 Platelets, Pheresis, Recall #B-536-5.
CODE Unit #32P52688
MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin.
RECALLED BY Manufacturer by letter September 22, 1994. Firm-initiated
recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit.
REASON Blood product, collected from a donor currently taking the
drug, Proscar, was distributed.
_______________
PRODUCT Platelets, Pheresis, Recall #B-537-5.
CODE Unit #26031-0099.
MANUFACTURER United Blood Service Blood Systems, Inc., Fort Smith,
Arkansas.
RECALLED BY United Blood Service Blood Systems, Inc., Scottsdale,
Arizona by telephone September 14, 1993. Firm-initiated
recall complete.
DISTRIBUTION Arkansas, Arizona.
QUANTITY 1 unit.
REASON Blood product, which was labeled with an incorrect
expiration date, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Recovered Plasma, Recall #B-539/542-5.
CODE Unit #s (a) 4524324, 4524342, 4524345, 4524351; (b) 4524351;
(c) 4524345; (d) 4524342 & 4524349.
MANUFACTURER Blood Care, Dallas, Texas.
RECALLED BY Manufacturer by telephone April 7, 1995 with follow-up
letter dated April 21, 1995 and May 5, 1995. Firm-initiated
recall complete.
DISTRIBUTION Texas, Switzerland.
QUANTITY 8 units were distributed.
REASON Blood products, in which the sterility of the collection
system was possibly compromised, were distributed.
_______________
PRODUCT Granulocytes, Pheresis, Recall #B-543-5.
CODE Unit #0313257.
MANUFACTURER Blood Care, Dallas, Texas.
RECALLED BY Manufacturer by letter February 24, 1995. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly reactive for the
antibody to the human immunodeficiency virus type 1 and 2
(anti-HIV-1/2), was distributed.
_______________
PRODUCT Platelets, Recall #B-549-5
CODE Unit #8091880.
MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas.
RECALLED BY Manufacturer by telephone April 12, 1995. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly reactive for the
antibody to the hepatitis C virus encloded antigen (anti-
HCV), was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
===================
_______________
PRODUCT Fresh Frozen Plasma, Recall #B-497-5
CODE Unit #s 09T47523, 09T47526, 09T47527, 09T47528.
MANUFACTURER American National Red Cross, Omaha, Nebraska.
RECALLED BY Manufacturer by letter June 9, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nebraska.
QUANTITY 1 unit was distributed.
REASON Blood product, which was not frozen within eight hours after
collection, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma, Recall #B-
509/510-5.
CODE Unit #s (a) 53FL24703, 53FL24696, 53FL24670, 53FX27703,
53FX27715, 53G81164, 53G81161, 53FQ22541; (b) 53FL24696,
53FL24670, 53G81164, 53G81161, 53FQ22541.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY Manufacturer by telephone November 23, 1993 with follow-up
letter dated November 30, 1993. Firm-initiated recall
complete.
DISTRIBUTION Maryland, Washington, D.C.
QUANTITY 2 units were distributed.
REASON Blood products, associated with a unit of pooled Platelets
which was contaminated with Propionibacterium acnes, were
distributed.
_______________
PRODUCT (a) Whole Blood, (b) Red Blood Cells; (c) Fresh Frozen
Plasma, (d) Recovered Plasma, Recall #B-514/517-5.
CODE Unit #s (a) 40GR41841; (b,c,& d) 40FL04624, 40GS42969.
MANUFACTURER American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY Manufacturer by letter March 15, 1995. Firm-initiated
recall complete.
DISTRIBUTION California, New York, Illinois.
QUANTITY 4 units were distributed.
REASON Blood products, which were incorrectly tested for HBsAg,
were distributed for transfusion and further manufacture.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma;
(d) Platelets, Pheresis For Further Manufacture, Recall #B-
526/529-5.
CODE Unit #s (a) 67762, V53612; (b) F67762; (c) F67762; (d)
P14730.
MANUFACTURER Central California Blood Center, Fresno, California.
RECALLED BY Manufacturer by letter dated between December 1993 and March
1994. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 4 units.
REASON Blood products, which tested negative for anti-HIV-1 but
were collected from donors who previously tested repeatedly
reactive for anti-HIV-1, were distributed for transfusion or
for further manufacture.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma, Recall #B-
530/531-5.
CODE Unit #15G22958 (a & b)
MANUFACTURER American Red Cross Blood Services, Boise, Idaho.
RECALLED BY Manufacturer by letter September 7, 1994; and by letter
September 14, 1994. Firm-initiated recall complete.
DISTRIBUTION Montana, California.
QUANTITY 2 units.
REASON Blood products, which were untested for hepatitis B surface
antigen (HBsAg), were distributed for transfusion.
_______________
PRODUCT Whole Blood CPDA-1, Recall #B-533-5.
CODE Unit #s P16003, P16004, P16005.
MANUFACTURER Sacramento Medical Foundation Blood Center, Sacramento,
California.
RECALLED BY Manufacturer on or about April 15, 1990. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 3 units.
REASON Blood product, which was labeled with an incorrect
expiration date, was distributed for transfusion.
_______________
PRODUCT Red Blood Cells, Recall #B-534-5
CODE Unit #s FC94621; FE06561.
MANUFACTURER Sacremento Medical Foundation Blood Center, Sacramento,
California.
RECALLED BY Manufacturer on or about May 6, 1991 and August 12, 1991.
Firm-initiated recall ongoing.
DISTRIBUTION California.
QUANTITY 2 units.
REASON Blood product, which was labeled with an incorrect
expiration date, was distributed.
_______________
PRODUCT Red Blood Cells, Recall #B-535-5.
CODE Unit #s FC45433, FC45434, FC45435, FC45436, FC45437,
FC45440.
MANUFACTURER Sacramento Medical Foundation Blood Center, Sacramento,
California.
RECALLED BY Manufacturer on or about July 13, 1990. Firm-initiated
recall ongoing.
DISTRIBUTION California.
QUANTITY 6 units.
REASON Blood product, which was labeled with an incorrect
expiration date, was distributed for transfusion.
_______________
PRODUCT Red Blood Cells, Recall #B-538-5.
CODE Unit #26033-1843.
MANUFACTURER United Blood Service Blood Systems, Inc., Fort Smith,
Arkansas.
RECALLED BY United Blood Service Blood Systems, Inc., Scottsdale,
Arizona by telephone March 1, 1994. Firm-initiated recall
complete.
DISTRIBUTION Arkansas
QUANTITY 1 unit.
REASON Blood product, which was labeled with an incorrect
expiration date, was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Optima Blood Oxygenators:
(a) Catalog #050212-000 - Hollow Fiber Open System w/open
filtered reservoir;
(b) Catalog #050214-000 - Hollow Fiber Open System w/open
non-filtered reservoir;
(c) Catalog #050255-000 - Hollow Fiber Membrane Oxygenator
w/no reservoir;
(d) Catalog #436112-000 - Catalog #050212-000 as above
combined with Heart/Lung Pack;
(e) Catalog #436114-000 - Catalog #050214-000 as above
combined with Heart/Lung Pack;
(f) Catalog #436155-000 - Catalog #050255-000 as above
combined with Heart/Lung Pack. Recall #Z-1018/1023-5.
CODE Lot Numbers: All product manufactured up to Lot #11Z7000.
MANUFACTURER COBE Cardiovascular, Inc, Arvada, Colorado.
RECALLED BY Manufacturer, by voice mail message sent November 28, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 23,436 units; (b) 1,006 units; (c) 9,184 units; (d)
2,780 units; (e) 252 units; (f) 1,440 units were
distributed.
REASON Cracked and leaking end caps at the arterial port and sample
luer.
_______________
PRODUCT Specific Centrysystem 3 Dialysis Control Units, Centrysystem
2 Dialysis Units with Ultrafiltration Control (UFC),
Centrysystem 2 Ultrafiltration Control Modules, and 3-Way
Bypass Valve Spares Kits, Recall #Z-1086-5.
CODE Various catalog and serial numbers, but all contain a 3-Way
Bypass Valve (p/n 860003-020).
MANUFACTURER Cobe Renal Care, Inc., Lakewood, Colorado.
RECALLED BY Manufacturer by letter June 19, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, international
QUANTITY 1,830 units were distributed.
REASON When the 3 Way By-Pass valve is in the "deliver dialysate to
dialyzer" mode, some of the dialysate may be shunted into
the bypass line, thereby reducing the prescribed flow of
dialysate to the dialyzer.
_______________
PRODUCT Digital Ultrasound System, Model EUB-515 Plus, device
provides pictorial representations of faint signals
reflected from inside the body for radiology, OB/GYN,
vascular, urological, G.I. and surgical ultrasound
examination, Recall #Z-1096-5.
CODE Serial numbers are as follows:
SE13689008 SE13689009 SE13690002 SE13690008 SE14153026
SE14153029 SE14242011 SE14242011 SE14242014 SE14374002
SE14374003 SE14374004 SE14374005 SE14374006 SE14403001
SE14403002 SE14403003 SE14403004 SE14403005 SE14403066
SE14403007 SE14403008 SE14403009 SE14403010 SE14465001
SE14465002 SE14465003 SE14465004 SE14465005 SE14486001
SE14486002 SE14486003 SE14486004 SE14486005 SE14826101
SE14826102 SE14826103 SE14826104 SE14826105 SE14918101
SE14918102 SE14918103 SE14918104 SE14918105 SE14918106
SE14918107 SE14918108 SE14918109 SE14918110 SE14919101
SE14919102 SE14919103 SE14919104 SE14919105 SE14919106
SE14919107 SE14919108 SE14919109 SE14919110 SE15018104
MANUFACTURER Hitachi Medical Corporation, Tokyo, Japan.
RECALLED BY Hitachi Medical Corporation of America, Tarrytown, New York,
by letter July 5, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 152 devices were distributed.
REASON The power supply for this device can fail due to fuses which
are inadequate to limit current flow.
_______________
PRODUCT Adult Sterile Cardia Stimulation Electrodes, Recall #Z-
1097/1098-5.
CODE (a) Model 830-ST pull dates: May 8, 1995; Jul 3, 1995, Sep.
22, 1995, Dec. 1, 1995, Mar. 15, 1996, Jun. 14, 1996, Jul.
12, 1996, Aug. 18, 1996, Sep. 15, 1996; (b) Model 230-ST
pull dates July 10, 1995, Sep. 15, 1995, Jan. 1995.
MANUFACTURER Cardiotronics Systems, Inc., Carlsbad, California.
RECALLED BY Manufacturer by letter April 20, l995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 5,036 units were distributed.
REASON The sterility of the products may be compromised due to an
incomplete packaging seal caused by sealing equipment
operator error.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT (a) Canalicular Collagen Implants, Part No. 0051; (b)
Canalicular Collagen Implants, Part No. 0057, Recall #Z-
1087/1088-5.
CODE Lot #s (a) D95151; (b) D95152.
MANUFACTURER Look Incorporated, Ada, Oklahoma.
RECALLED BY Manufacturer by telephone July 11, 1995 with follow-up
letter dated July 12, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Tennessee.
QUANTITY 409 boxes were distributed.
REASON The collagen implants are labeled with the incorrect size.
_______________
PRODUCT Paramax Urea Nitrogen Reagent, intended for quantitative
determination of urea nitrogen in serum, plasma or urine,
Recall #Z-1089-5
CODE Lot #s: BUN 556A through BUN 566A.
MANUFACTURER Dade Diagnostic of Puerto Rico Inc., Aguada, Puerto Rico.
RECALLED BY Dade International Inc., Miami, Florida.
DISTRIBUTION Nationwide, international.
QUANTITY 68,163 packages were distributed from 8/15/94 to 5/15/95.
REASON Patient samples containing abnormal urea nitrogen (UN)
levels above the upper limit of linearity may not always be
flagged by the system, the results printed by the analyzer
may be within the dynamic range.
_______________
PRODUCT Sonoline SI-450D Ultrasound Imaging System with Version
1.1.5 Software Installed, product is used to detect
abnormalities in soft tissue structures and vessels, Recall
#Z-1095-5.
CODE All lots.
MANUFACTURER Siemens Medical Systems, Inc. Issaquah, Washington.
RECALLED BY Manufacturer. All products were sent a product alert dated
December 21, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, international.
QUANTITY 98 units were distributed.
REASON The transducers normally compatible with the system may
exceed their acoustic output and/or surface temperature
specifications due to software related problems.
END OF ENFORCEMENT REPORT FOR AUGUST 16, 1995. BLANK PAGES MAY
FOLLOW
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